Navigating Medical Device Regulations: A Comprehensive Guide to Market Access in Europe, Switzerland, and the UK

Navigating Medical Device Regulations: A Comprehensive Guide to Market Access in Europe, Switzerland, and the UK

Introduction and Guide to Market Access

In the intricate landscape of medical device regulations, successfully bringing products to market requires a thorough understanding of the varying requirements in different regions.

This market access guide provides comprehensive insights into the European Union (EU), Switzerland, and the United Kingdom (UK) regulations, shedding light on crucial aspects such as Authorized Representatives, Importers, and other economic operators. 

Crafting your Marketing Strategy

A well-defined marketing strategy is the foundation for entering any market. It is essential to carefully consider the products you wish to sell and the targeted regions. While the instinct might be to reach every corner, strategic planning helps avoid unnecessary costs. 

 Post-Brexit, the complexity has increased, necessitating separate Authorized Representatives and Importers for each region. 

Understanding Economic Operators

Authorized Representatives

In the EU, a manufacturer outside the region must appoint an Authorized Representative.

The Authorized Representative, prominently identified on product labels, shoulders responsibilities such as verifying EU conformity, registration obligations, and cooperation with competent authorities. 

EU MDR Article 11: Key Responsibilities of Authorized Representatives

  • Verify the EU declaration of conformity and technical documentation. 
  • Keep copies of technical documentation and the EU declaration of conformity. 
  • Comply with registration obligations. 
  • Provide information to demonstrate device conformity. 
  • Forward requests from competent authorities to the manufacturer. 
  • Cooperate on preventive or corrective actions. 
  • Immediately inform the manufacturer about complaints and suspected incidents. 
  • Terminate the mandate if the manufacturer acts contrary to obligations. 


Importers situated within the EU play a pivotal role in ensuring products’ adherence to regulations before entering the market. They verify CE marking, proper labelling, and other compliance criteria.

Significantly, they are obliged to keep meticulous records and promptly address non-compliance concerns. 

EU MDR Article 13: Duties of Importers

  • Place on the market only devices in conformity with the regulation. 
  • Verify CE marking, EU declaration of conformity, and manufacturer’s identification. 
  • Ensure proper labeling and instructions for use. 
  • Verify UDI assignment by the manufacturer. 
  • Maintain a register of complaints, non-conforming devices, recalls, and withdrawals. 
  • Cooperate with authorities on corrective actions. 
  • Inform the manufacturer and authorities about non-compliance and serious risks. 

The European Market

EU MDR 2017/745 and IVDR 2017/746

For medical devices and in-vitro diagnostics, compliance with EU MDR and IVDR is paramount. Manufacturers must meticulously follow the regulatory requirements outlined in these legislations.

Initiating with Article 10 and ensuring conformity with EU standards is the cornerstone. 

EU MDR Article 10: General Obligations of Manufacturers

  • Verify compliance with legislation, specifically EU MDR or IVDR Article 10. 
  • Comply with the requirements of EU MDR or IVDR Article 10 for economic operators. 
  • Provide necessary information to authorized representatives and importers. 

Authorized Representative

The EU Authorized Representative must be well-versed in EU MDR and IVDR requirements. The role encompasses tasks from verifying documentation to cooperating with authorities.

Transparency is critical, with the Authorized Representative’s details prominently displayed on product labels. 


Importers act as the last line of defence before products hit the market. As per Article 13, their verification processes ensure that only compliant devices enter the EU.

The importer’s role includes handling complaints, cooperating with competent authorities, and maintaining a comprehensive register. 

EUDAMED Registration

EUDAMED, the European Database for Medical Devices, plays a pivotal role in the regulatory landscape. Manufacturers, Authorized Representatives, Importers, and other entities must register in EUDAMED to obtain the Single Registration Number (SRN).

This digital hub facilitates information exchange, ensuring transparency and traceability. 

EUDAMED Registration Process

EUDAMED, the European Database for Medical Devices, is pivotal for transparent information exchange among stakeholders. The registration process involves: 

1. Identify your Role

Determine if you’re a Manufacturer, Authorized Representative, or Importer, each with unique responsibilities.

2. Access EUDAMED

Create an account on the user-friendly EUDAMED platform

3. Provide Details

Enter essential company information and specify your role.

4. Verification

Undergo a verification process to confirm the legitimacy 

5. Get SRN

Receive a Single Registration Number (SRN) upon successful verification.

6. Maintain Compliance

Regularly update the information to stay compliant. 

7. Information Exchange

Utilize EUDAMED for efficient information exchange with authorities and stakeholders. This streamlined process ensures regulatory compliance and facilitates seamless interaction within the EU’s medical device landscape. 



Switzerland, no longer part of the Mutual Recognition Agreement, mandates manufacturers outside the EU to appoint Authorized Representatives and Importers within Switzerland. The regulations mirror EU MDR and IVDR, emphasizing compliance. 

Differences in Switzerland

While Switzerland aligns closely with EU regulations, distinctions exist. The CH-REP symbol stands in for the EC REP symbol, and a unique registration process, distinct from EUDAMED, adds a layer of complexity. 

UK Market Access: Navigating the Post-Brexit Scenario

The UK Responsible Person

Post-Brexit, the UK Responsible Person assumes a role akin to the EU Authorized Representative. The UK MDR 2002 sets out responsibilities, emphasizing conformity checks, complaint management, and immediate reporting of non-compliance. 

UK MDR 2002 Responsibilities of the UK Responsible Person

  • Ensure the declaration of conformity and technical documentation are in order. 
  • Keep copies of technical documentation and the declaration of conformity. 
  • Provide information to demonstrate device conformity to the MHRA. 
  • Cooperate with the MHRA on preventive or corrective actions. 
  • Immediately inform the manufacturer about complaints and suspected incidents. 
  • Terminate the legal relationship if the manufacturer acts contrary to obligations. 

Symbolic Absence

Unlike the EU, the UK lacks a designated symbol for the Responsible Person. The absence prompts a textual mention on labels. Notably, this requirement applies to UKCA-marked products post-Brexit. 


Navigating the regulatory landscape for medical devices demands a nuanced understanding of region-specific requirements.

From strategic marketing planning to compliance with EU, Swiss, and UK regulations, this guide provides a detailed roadmap for manufacturers aiming to ensure seamless market access while embracing the intricacies of post-Brexit realities.

EUDAMED is a pivotal component, serving as the digital nexus for regulatory information exchange, ensuring compliance and traceability. 

Mastering Medical Device Audits: A Roadmap to Preparedness and Compliance Excellence

Mastering Medical Device Audits: A Roadmap to Preparedness and Compliance Excellence

Facing a medical device audit can be daunting, but with meticulous preparation and strategic responses, companies can turn this challenge into an opportunity for building a robust quality system.

Tips for Mastering Medical Device Audits

This article provides a detailed roadmap for mastering medical device audits, covering essential steps from internal audits to adeptly handling regulatory findings.

1. Demystifying Audits

Understanding the fundamental concepts behind medical device audits is crucial. ISO 19011 defines audits as systematic, documented, and independent processes for obtaining objective evidence.

This section also outlines the different types of audits, including internal and external audits conducted by regulatory bodies.

2. Navigating US and EU Audits

Medical device audits are mandatory for all device classes, but specific requirements vary depending on regulatory bodies and device classification.

In the EU and US, audits for medium to high-risk devices typically involve Notified Body audits for MDR/IVDR compliance and ISO 13485:2016 certification, FDA inspections for 21 CFR 820 compliance and manufacturing capability verification, and periodic surveillance audits.

Additionally, manufacturers are subject to unannounced and “for cause” inspections triggered by various issues.

3. Strategic Audit Preparation

Thorough preparation for an audit or inspection involves continuous auditing practices, mock audits, and self-identification of issues. Internal audits should be conducted rigorously, acting as rehearsals for external audits.

Mock audits, conducted by independent third parties, can reveal areas for improvement. Self-identifying issues and implementing corrective actions promptly demonstrates a proactive approach to compliance.

4. Selecting the Ideal Audit Host

When selecting an audit host, it’s crucial to choose someone who represents the company well, possesses in-depth knowledge of its operations and quality management system, and can handle pressure effectively.

The audit host is pivotal in ensuring a smooth and successful audit, so selecting the right individual is essential.

5. Document Readiness for Audits

To ensure a smooth audit process and avoid delays, organizations should pre-identify and readily have all necessary documents, including regulatory information, certificates, and records.

A centralized regulatory information management (RIM) system can significantly streamline the process by storing and linking to relevant documents from other systems.

6. Audit In-Action

During an audit, it is crucial to actively manage the process. The company host should introduce the organization and conduct a facility tour. While the auditor directs the audit, the host should assist and guide them throughout the process.

For unannounced inspections, a procedure should outline the reception and handling of such audits, including designating primary contacts and alternates.

Ideally, multiple company representatives should accompany the auditor, and they should not be left alone at any point. A “front room” team should transcribe every interaction and relay information to a “back room” team for support.

7. Best Information Sharing Practices

Employees should provide requested information to auditors but should consult with executives before sharing sensitive documents. Auditors should access information through photocopies or limited computer access.

Original documents can be presented but should not be kept by auditors. All information should be prepared, verified, recorded, and marked “Confidential” or “Proprietary” before being provided to auditors. An extra copy should be made for audit files.

8. Addressing Gaps in Information

Address missing or incorrect information by acknowledging the issue and discussing appropriate actions under the existing quality system. Be prepared to receive findings from any inspection and ensure that they are understood by both parties.

Address all findings diligently and respond to the regulatory body in charge of the audit with a satisfactory plan for correcting and preventing the recurrence of the identified issues.


In conclusion, medical device audits, though challenging, can be navigated successfully with thorough preparation and strategic responses.

Embrace the audit journey as an opportunity for continuous improvement, showcasing a commitment to compliance and the delivery of safe and effective medical devices.

Mastering medical device audits is not just a regulatory requirement – it’s a pathway to excellence in quality systems and product lifecycle management.

Establish a Medical Device Startup Company

Establish a Medical Device Startup Company

Introduction: Medical device startups play an essential role in revolutionizing patient care and improving quality of life. If you share our passion for innovation, starting a medical device company could prove rewarding yet challenging – this article offers comprehensive guidance to help get one started.

Tips to start a Medical Device Startup Company

1. Brainstorm an Engaging Idea:

Every successful medical device startup begins with an original idea. Start by researching the healthcare industry and identifying unmet needs or potential gaps in existing solutions; engaging healthcare providers, clinicians and patients for insights to gain further understanding;  engaging healthcare providers, clinicians/patients for insight.

Having this insight allows for creative problem-solving ideas which meet genuine needs while offering commercial viability potential.

2. Conduct Market Research:

Once your idea is developed, conduct extensive market research to gauge its viability. Consider factors like target market size and competition analysis; reimbursement policies consideration; pricing strategies investigation and market adoption factors as part of this analysis process.

Conducting such research will allow you to refine and assess the commercial potential of your idea while making more informed decisions in your startup journey.

3. Create an Effective and Diverse Team:

A strong and diverse team is critical to the success of any medical device startup. Bring on board experts with experience in product development, clinical research, marketing and finance; find individuals passionate about your mission with skills to overcome any hurdles; partner with advisors, consultants and industry professionals in order to leverage their knowledge and networks.

Establishing your product in multiple markets successfully relies heavily on finding an experienced regulatory partner who can collaborate on this endeavor.

4. Create a Prototype and Proof of Concept:

Give life to your vision by developing a prototype and proof of concept. This step involves translating engineering designs to functional prototypes and conducting preliminary tests – common challenges medical device startups encounter during this step include prioritizing features that set their product apart while iterating upon user, expert, and advisor feedback to refine its design according to user input received; additionally it’s wise to keep regulatory requirements front of mind to ensure compliance from day one.

5. Navigating the Regulatory Landscape:

Navigating and understanding the regulatory environment are integral parts of starting a medical device company, and OMC Medical’s team of regulatory affairs specialists can offer invaluable assistance here.

They know exactly what steps are necessary to gain regulatory clearance or approval for your medical device – their knowledge of FDA or CE marking requirements can help streamline this path, saving time and resources while ensuring compliance.

6. Secure Funding:

Producing a medical device from concept to commercialisation requires significant financial resources. In order to secure funding sources such as angel investors, venture capitalists, government grants and crowdfunding platforms – identify them beforehand by conducting due diligence processes with potential angel or venture investors before creating your pitch deck and business plan outlining market potential, competitive advantages and financial projections; develop relationships with prospective investors as you prepare for due diligence processes with them; seek guidance from experienced entrepreneurs or join incubator and accelerator programs offering funding options;

7. Establish a Go-to-Market Strategy:

Craft an inclusive go-to-market plan, covering marketing, sales and distribution channels. Create key opinion leaders as supporters for your product or service; employ digital marketing strategies or attend industry trade shows as means of increasing awareness while sparking interest; establish distribution channels to guarantee efficient product reach among target users.

8. Adopt Continuous Learning and Innovation:

For success in today’s ever-evolving medical device industry, cultivating a culture of continuous learning and innovation is paramount. Keep abreast of research findings, technological advancements, regulatory requirements and feedback from users and healthcare professionals on ways your product could be enhanced further; adjust accordingly in response to market dynamics and user needs in order to sustain growth over time.

Conclusion: Starting a medical device company requires innovation, persistence and careful strategic planning. By following these steps and drawing upon the experience and knowledge of industry experts, you can successfully navigate the complexities of the healthcare industry and develop groundbreaking medical devices that improve patient outcomes while contributing to expanding healthcare overall.

Finding an exciting medical device startup idea requires extensive research and investigation. Here are a few sources and methods that may help you uncover an impressive concept to move your vision forward:

Market Research:

Conduct market research to identify unfulfilled needs, gaps or challenges within the medical device industry. Assess current trends, emerging technologies and market dynamics while noting any areas where existing solutions fall short or innovative approaches could greatly enhance performance.

Market research tools available around the globe are invaluable resources for medical device startups. Here are a few commonly utilized ones:

  •  Statista: Statista is a user-friendly market research platform providing access to various statistics, market reports, industry studies on medical devices as well as consumer trends across numerous fields such as medicine.
  •  GlobalData is an industry leader in business intelligence and market research reports, offering in-depth analyses, forecasts and insights into the medical device industry – covering market trends, competitive landscape and emerging technologies.
  •  PHE Statistics: PHE provides regional-specific healthcare system NHS data platforms available worldwide.
  •  NHS Knowledge and Library Hub: Here you will find full-text versions of books, journal articles and access to NHS libraries of resources.
  •  PubMed: PubMed is an acclaimed database for biomedical literature research. With access to an expansive archive of research articles, clinical studies, and scientific publications related to medical devices, healthcare technologies and therapies – making it an indispensable source for keeping abreast of recent advancements in healthcare research and therapeutic advancement – PubMed can be used as an invaluable source for keeping abreast with recent innovations.
  •  IBISWorld: IBISWorld offers industry reports, market analyses and company profiles covering multiple industries – including medical devices. Their essays cover market trends, performance metrics and growth forecasts that provide invaluable market intelligence.
  • Google Trends: By using Google Trends, it is possible to gain an in-depth view of keyword popularity and search volume trends for medical device-related words or topics over time. With this tool at your disposal, it can provide valuable insights into market demand, consumer interest patterns and emerging trends relating to medical devices.
  • Euromonitor International: Euromonitor International offers market research reports and analyses across multiple industries, such as healthcare and medical devices. Their reports provide insight into market size, competitive landscape, consumer behaviour in various regions as well as regional differences.
  •  MedTech Innovator: MedTech Innovator is an international platform that presents medical device startups and provides insights into emerging technologies and innovations within the medical device industry. Additionally, this platform provides market trends, investor perspectives, networking events and networking opportunities.

These tools can assist you in gathering market data, industry trends and competitor analysis so you can make educated decisions regarding your medical device startup. Be sure to supplement them with primary research, expert interviews and validation from potential users for a complete understanding of the market.

1. Healthcare Professionals and Experts: For insights and perspectives from relevant healthcare professionals in providing healthcare and patient care services. These discussions may reveal what challenges healthcare professionals encounter when providing patient care services; their feedback could point out areas where medical devices could make significant impacts in real-life scenarios – sometimes direct action may be the key to success!

2. Addressing Patient Needs and Experiences: Pay close attention to patient needs and experiences by gathering stories, engaging with patient advocacy groups, conducting surveys or interviews and carefully listening for answers about challenges, limitations or ways medical devices could enhance quality of life or healthcare outcomes.

3. Solicit Feedback From Potential Users: Collect feedback from prospective users such as healthcare professionals, patients, caregivers and any other stakeholders involved with producing your medical device through interviews, focus groups or surveys in order to discover their pain points, preferences and desires for improved medical devices. Pay close attention as prospective users may provide invaluable feedback that can shape your idea while meeting end user requirements.

4. Technology and Innovation Hubs: Explore technology and innovation hubs such as startup incubators, accelerators or research centres dedicated to medical devices or healthcare. These hubs may offer resources, mentorship and networking opportunities with industry professionals and investors; engaging with these communities could open your mind up to new perspectives and foster creative problem-solving techniques.

5. Literature Review and Intellectual Property Analysis: When conducting a literature review related to medical devices, conduct an intensive analysis of all existing research, patents, scientific publications and intellectual property pertaining to them. This can provide insights into areas where significant advances have been made or where innovation may be necessary; intellectual property analysis also sheds light on untapped opportunities or possible areas for differentiation.

Keep in mind that coming up with an innovative idea requires research, creativity and industry knowledge. Be open to gathering varying viewpoints while validating your concepts through market research or feedback from others.

Create a Prototype and Proof of Concept

There are many companies that specialize in helping entrepreneurs and startups with prototype design. Their services range from consulting through prototyping – here are a few notable companies operating in this space:

1. IDEO: IDEO is an international design and innovation firm known for its human-centered design approach. Their services encompass product design, prototyping and designing strategy development as well as helping entrepreneurs create prototypes that align with user needs and market requirements.

2. Proto Labs: Proto Labs is a rapid prototyping and manufacturing service provider, offering 3D printing, CNC machining, injection molding and fast turnaround times to rapidly transform designs into functional prototypes.

3. Dragon Innovation: Dragon Innovation provides hardware startups with expert design, engineering and manufacturing support services from prototype design through mass production of their product development efforts.

4. Bresslergroup: Bressler group is a design and innovation consultancy, offering startups assistance in creating innovative product concepts and translating them to functional prototypes. Their specialty lies in user-centered design; furthermore they also offer industrial design engineering as well as prototyping expertise.

5. PCH International: PCH International is a product development and supply chain management firm that works with both startups and established brands alike, offering services like prototyping, manufacturing and logistics that help bring product ideas to fruition for startups.

6. Spark Innovations: Spark Innovations is a product design and development firm, specializing in turning ideas into prototypes and manufacturing-ready designs. Their services encompass industrial design, mechanical engineering, prototyping techniques and various other disciplines of study.

7. Altitude: Altitude is a design consultancy that assists startups with product design and development. They specialize in concept ideation, prototyping and user experience design services to produce engaging prototypes with functional capabilities that enable companies to test out their ideas with.

8. TTP (The Technology Partnership): TTP is an engineering and technology development firm offering product design, prototyping and manufacturing services for medical devices, consumer electronics and industrial products. Their teams boast extensive expertise across their various areas of specialization.

These companies specialize in working with startups, providing expertise, technical skills, and resources that can assist your prototype design from conception to realization. Selecting one that best meets your needs, budget, and project requirements is paramount.

Navigating the Regulatory Landscape

Navigating the regulatory environment when starting a medical device company is critical to its success. Adherence to regulatory requirements ensures patient safety, product efficacy and market access regardless of your launch location. Here are some key points for navigating this terrain:

1. Determine Applicable Regulations: Identify all regulatory bodies and laws relevant to medical devices in your target market, such as FDA in the U.S. regulating them under Food, Drug, and Cosmetic Act or In Vitro Diagnostic Regulation (IVDR or MDR) in Europe regulating them accordingly. Knowing which laws pertain directly to your device’s success is of utmost importance for its success.

2. Classify Your Device: Medical devices can be divided into various risk categories depending on their intended use and potential risks to patients, with each category determining regulatory requirements and levels of scrutiny for market approval. By classifying your device appropriately (Class I, II or III) you can better understand regulatory pathways, conformity assessment procedures and documentation requirements applicable.

3. Establish a Regulatory Strategy: From early in product development, create an in-depth regulatory strategy plan. This should include all steps and timelines necessary for regulatory compliance such as preclinical testing, clinical studies, quality management system implementation, regulatory submissions etc. Partner with experts or consultants to make sure your plan aligns with regulatory requirements.

4. Conduct Preclinical and Clinical Studies: Depending on the risk category of your device, preclinical and clinical studies may be required to demonstrate its safety and efficacy. Preclinical testing includes lab and animal models; while human participation testing occurs during clinical studies. Data generated during these studies provides regulatory submissions with evidence of your device’s safety and performance.

5. Quality Management System (QMS): Establish and implement an ISO 13485 compliant quality management system in order to comply with processes, design controls, manufacturing, post market surveillance requirements as well as regulatory standards imposed upon your processes and their system requirements – this ensures consistency, traceability and documentation throughout product life cycles.

6. Prepare Regulatory Submissions: Gather all necessary paperwork and create regulatory submissions for market approval, such as technical files, design dossiers, labelling information, risk analyses and clinical data. Ensure your documents comply with any specific requirements set by regulatory bodies in terms of format, content and process for submissions.

7. Post-Market Surveillance: Once regulatory clearance or approval is secured, establish post-market surveillance processes to track and report adverse events; conduct clinical follow-up studies post market; as well as create a vigilance system to track device’s ongoing safety and performance monitoring.

8. Keep Current on Regulatory Developments: As regulations for medical devices can change at an ever-increasing pace, stay abreast of any updates or revisions that might impact your device by engaging with industry associations or regulatory agencies as well as attending conferences or webinars to remain aware of new developments and ensure compliance.

Navigating the regulatory environment takes careful planning, strict adherence to standards and extensive knowledge of regulations affecting medical devices in your target market. Engaging regulatory specialists or consulting experts is invaluable when it comes to meeting compliance obligations, speeding approval processes and successfully bringing medical devices or services products or services to market.

Secure Funding:

As with anything, funding options for medical device startups vary across regions. Below are a few sources in Europe, the UK, Switzerland, USA, China and India,


1. European Investment Fund (EIF): The EIF offers funding through various programs such as venture capital funds and equity investments to support innovative startups across Europe – specifically medical device industry startups.

2. Horizon Europe: This European Union program offers grants, loans and equity investments to promote research and innovation across various fields – such as healthcare and medical technology.

3. European Investment Bank (EIB): The EIB offers financing and investment support to European innovative companies such as medical device startups through venture capital funds and direct investments.

United Kingdom:

1. Innovate UK: As the UK’s innovation agency, Innovate UK provides funding opportunities to both early-stage and established medical device businesses through programs that support research, development, and commercialisation activities.

2. Crowdfunding: Crowdfunding is famous in the UK and is known to attract bigger investors in the pool of thousands of investors. Standing out here is difficult but right technology has raised millions through this platform.


1. Swiss Innovation Agency (Innosuisse):

Innosuisse provides funding and support services to startups engaged in innovative projects within Switzerland, such as medical device startups. They offer grants, coaching sessions, as well as access to their network of experts and resources.

 United States:

1. National Institutes of Health (NIH): The NIH offers grants, contracts and funding opportunities for early stage and translational medical device research projects, including funding opportunities such as Small Business Innovation Research grants (SBIR) and Technology Transfer Research programs which assist startups creating innovative medical device products.

2. Small Business Administration (SBA): The SBA offers various loan programs, such as its 7(a) loan program that provides medical device startups with funding.

Medical device startups in these regions must research each funding source carefully and understand its eligibility criteria, application processes and terms in order to gain access to funds that could help their venture thrive. From local government agencies and incubators/accelerators/grant competitions all these sources could offer funding opportunities.


1. China National Medical Products Administration (NMPA) Funds: The NMPA provides grants and funding programs designed to facilitate developing and commercializing innovative medical devices in China, with an aim of encouraging domestic innovation while improving healthcare delivery systems in China.

 2. China Healthcare Investment Funds: Numerous investment funds specializing in healthcare and medical device industries exist within China, supported by government bodies to assist startups creating cutting-edge medical technologies and devices.

 3. Chinese Venture Capital Firms: China has an expansive venture capital ecosystem, with firms specialising in healthcare and medical technology investments offering funding, strategic advice and industry connections to medical device startups looking to break into Chinese market. These venture capital firms can be vital allies when venturing into new markets – be it medical device sales or distribution contracts in China.

 4. State and Local Government Programs: China has implemented funding programs designed to bolster local startups and foster innovation, including grants, subsidies and other forms of financial incentive to medical device companies located within their borders.

5. Partnerships With Chinese Companies: Medical device startups seeking funding and resources may benefit from entering strategic partnerships with established Chinese medical device manufacturers. Such relationships could take the form of licensing agreements, joint ventures or co-development initiatives that enable startups to capitalize on expertise provided by partners as well as distribution networks provided by partners.

It is crucial to recognize that successfully navigating China’s funding landscape requires local expertise and in-depth knowledge of market dynamics and regulations in China. Partnering with advisors, incubators or accelerators that specialize in healthcare funding opportunities could prove helpful in providing guidance.

China is an attractive location for medical device startups to find funding and expansion opportunities due to its expanding healthcare market and emphasis on innovation. To be successful at finding financing in this market, however, extensive research, due diligence and knowledge of local regulations must be performed prior to considering funding opportunities in China..

India provides various funding resources and programs to medical device startups. Here are a few:

1. Biotechnology Industry Research Assistance Council (BIRAC): As a government organization, BIRAC offers various funding schemes for innovative projects within biotechnology and healthcare. Startups creating medical devices may want to consider applying for grants such as the Biotechnology Ignition Grant (BIG), Biotechnology Industry Partnership Programme (BIPP), or Small Business Innovation Research Initiative (SBIRI).

2. Department of Science and Technology (DST)-Technology Development Board (TDB): The DST-TDB provides financial assistance through grants and soft loans for technology development and commercialisation, with medical device startups eligible for funding under either its Technology Development and Utilization Programme (TDUP) or Seed Support System (SSS).

3. Startup India: The Startup India initiative from the Government of India provides numerous benefits and support mechanisms for startups operating within medical device sector, including medical device companies. Startups may gain access to Fund of Funds for Startups (FFS) schemes, tax exemptions, and ease of regulatory compliance.

4. Incubators and Accelerators: India boasts an increasing number of healthcare and medical technology incubators and accelerators that offer funding, mentorship, networking opportunities, access to infrastructure resources as well as funding – such as T-Hub, Centre for Innovation Incubation and Entrepreneurship (CIIE), Atal Incubation Centers (AICs).

5. Venture Capital and Angel Investors: India boasts an active venture capital and angel investor community which invests heavily in healthcare technology startups. Engaging with these investors can provide access to funding as well as the industry expertise essential to growing medical device companies.

6. Public Sector Undertakings (PSUs): Indian public-sector PSUs can collaborate with startups to provide funding for innovative projects. Medical device startups could find partners such as Bharat Heavy Electricals Limited (BHEL), Indian Oil Corporation Limited (IOCL), or Hindustan Petroleum Corporation Limited (HPCL).

Medical device startups looking for funding opportunities in India’s diverse healthcare ecosystem must carefully research eligibility criteria, application processes and terms associated with each funding source or program before exploring possible avenues. Engaging with startup competitions, pitch events or networking forums could also open doors to investors that could open funding doors in this market.

Common sources:

Venture capitalists (VCs) and angel investors play key roles in funding startups and driving innovation across various industries – including medical device.

Venture capitalists (VCs) are professional investors that typically employ institutional funds in high-growth startups through venture capital firms. Operating through venture capital firms, VCs provide capital in exchange for equity or ownership stakes in startups in exchange for significant funding investments.

Before making their decisions on investments, venture capitalists conduct extensive due diligence analyses of market potential, growth potential assessment and potential risks of the startups they plan to invest in, to make informed investment decisions. Furthermore, venture capitalists offer strategic guidance, mentorship services, industry connections as well as access to their network which all help drive medical device startups forward!

Angel investors, on the other hand, are typically wealthy individuals who make early-stage startup investments. In contrast to venture capitalists, angel investors tend to be more flexible with their criteria and can provide funds at any point throughout a startup’s journey.

Angels tend to take higher risks by supporting promising ideas with passionate founders while providing financial support as well as mentorship and industry insights from previous endeavours. Angel investors play an essential role in kickstarting medical device startups and helping them gain traction in their respective markets.

Venture capitalists and angel investors offer medical device startups invaluable sources of funding and support, with venture capitalists being an especially invaluable source. Leveraging them can give startups access to capital, expertise, industry connections and guidance that helps navigate competitive landscapes, accelerate growth and secure long-term success.

Entrepreneurs must understand the differences in investment criteria for both types of investors in order to approach those most suitable for their startup’s stage of development and funding requirements.

Contact our expert team of consultants today and see how they can assist with specific support groups and agencies that offer funding solutions.

Adopt Continuous Learning and Innovation:

AI-Based Products: One of the primary concerns among startups today is creating trustful data sets for AI-powered products; numerous firms specialize in this process and can assist you with adding this capability into medical devices. Below are a few noteworthy firms:

1. IBM Watson Health: IBM Watson Health is a division of IBM that specializes in using AI and data analytics for healthcare purposes, offering solutions such as image analysis, genomic research, drug discovery processes and clinical decision support systems.

2. Google Health: Google Health employs AI technologies to develop innovative healthcare solutions, undertaking projects such as AI-powered diagnostic algorithms, natural language processing for medical records and predictive analytics for disease management.

3. Microsoft Healthcare: Microsoft Healthcare’s mission is to revolutionize healthcare with AI solutions. They offer tools, platforms, and services which enable developers to build and deploy AI applications within healthcare – as well as cloud infrastructure to speed deployment of these apps.

4. Arterys: Arterys offers AI-powered medical imaging solutions. Employing deep learning algorithms to analyze medical images and assist radiologists with diagnosing various conditions, Arterys’ platform enables faster and more accurate image analysis to facilitate early detection and treatment planning.

5. Aidoc: Aidoc is an AI-powered radiology solution provider. Their algorithms scan medical images quickly and efficiently to quickly recognize critical findings, helping radiologists streamline workflow while improving diagnostic accuracy.

6. BenevolentAI: It is an innovative artificial intelligence (AI) company that combines AI with scientific research in order to accelerate drug discovery and development. They utilize machine learning and data analytics tools in order to rapidly identify potential drug candidates and optimise treatment strategies quickly; providing services in oncology, neurology and rare disease areas among others.

7. Sensyne Health: Sensyne Health specialises in applying AI and clinical data analysis to advance patient care and medical research. They collaborate with healthcare providers and research organizations to design AI-powered solutions that enhance disease detection, patient monitoring, treatment outcomes and treatment success rates.

8. Imperial College London’s Faculty of Medicine conducts cutting-edge AI research for healthcare, working closely with industry partners and startups on AI technologies and algorithms that enhance diagnostics, drug discovery and personalized medicine.

9. Cambridge Medical Robotics: Cambridge Medical Robotics specialises in designing robotic systems for minimally invasive surgical procedures using cutting edge AI and machine learning technology to increase surgical precision, improve patient outcomes and accelerate recovery times.

10. PrecisionLife: PrecisionLife uses AI and machine learning techniques to analyze complex datasets and uncover unique insights for personalized medicine projects such as disease stratification, drug target identification and optimizing treatment strategies.

Before selecting an artificial intelligence (AI) development company, it’s crucial to assess their expertise, track record and experience within healthcare. Take into account their capacity for compliance with data privacy and regulatory issues as well as understanding of medical device manufacturing challenges. Partnering with an established AI firm will enable you to leverage cutting-edge technology while hasten development of your medical AI device.

Software-Based Products –

There are many solutions providers for IT support where  companies assist in the creation or development of software-based products or applications for yous, so as to guarantee optimal outcomes we suggest working with one or more of our recommended partners:

1. Blum Health’s Blum Connect offers an all-in-one solution for clinical application software development teams’ software development needs. Build or have your team build code and rules themselves.

2. Light-it offers comprehensive software development and security services from start to finish, while Google Health pioneered healthcare innovation with end-to-end solutions, cloud computing services, and security services.

3. Microsoft Healthcare – Provides premier healthcare solutions for developers through their cloud platform and custom software designs.

Contract Manufacturing Services for Healthcare Products: Numerous contract manufacturing services specialize in healthcare product production at scale. Such firms possess the expertise and infrastructure required for producing medical devices, pharmaceuticals and other items related to healthcare on an industrial scale – countries like UK, India, China have invested significantly in this area while DIT of these countries’ large-scale healthcare product production works closely with startups operating within this space.

June Newsletter 2023

June Newsletter 2023


Implementation of Regulation (EU) 2023/1194 on transitional provisions for products without an intended medical purpose | 21 June 2023

The deadlines for Annex XVI products mentioned in Implementing Regulation (EU) 2022/2346 has been extended in the Implementing Regulation (EU) 2023/1194 of 20 June 2023. To find out more about the extended deadlines, click here.

Addendum to MDCG Position Paper on the application of Article 97 | 30 June 2023

The position paper MDCG 2022-18 was published to provide a uniform approach to the application of Article 97 of MDR 2017/745 on medical devices (MDR) in situations where a certificate issued under the Directives has expired or expires before issuance of the necessary certificate(s) in accordance with the MDR.

The use of Article 97 MDR in those situations was meant to be a temporary solution. The goal of the position paper MDCG 2022-18 was to avoid a disruption of supply of devices on the EU market needed for health systems and patients.

Cybersecurity and Privacy in AI – Medical imaging diagnosis | 07 June 2023

ENVISA has released a report on Cybersecurity and privacy in AI – Medical imaging diagnosis. This report allows better assessment of the reality that artificial intelligence brings its own set of threats, which consequently insists on the search for new security measures to counter them.

This guide also strongly emphasizes privacy issues in the same way as cybersecurity issues, privacy being one of the most important challenges facing society today.

Security and privacy are intimately related, but both equally important, and a balance must be made specific to each use. As a result, as seen in this report, efforts to optimize security and privacy can often come at the expense of system performance.


ANSM notification on affixing barcodes for medical devices FSNs | 12 June 2023

n order to facilitate the identification of the devices affected by a field safety corrective action, ANSM recommends that manufacturers specify the following elements, directly in the field safety notice (FSN or appendix or web link that can be consulted directly):

  • Media allowing the automatic capture of data (one- or two-dimensional barcode) of the medical devices concerned, in particular those already having a UDI (unique device identification), for computerized inventory management.
  • The types of end recipients in the distribution chain concerned, to the manufacturer’s knowledge: pharmacy, pharmacy for indoor use, medical biology analysis laboratory, city care structure, large and medium-sized supermarkets, home healthcare provider …
  • The exhaustive list of references and batches or serial numbers targeted by the field safety corrective measure (unless all the batches are targeted).


Medical device distributors not required to submit device notifications until further notice | 06 June 2023

The Finnish Medicines Agency (Fimea) has temporarily waived the requirement for medical device distributors to submit device notifications in accordance with the Medical Devices Act. This decision aims to simplify the process and reduce the burden on distributors.

Fimea has introduced an electronic submission service for operator details, but it currently does not include device data. The suspension of device notifications seeks to balance regulatory compliance and practicality.


HPRA notification on new case management system for medical devices | 06 June 2023

HPRA will implement a new case management system for medical devices from 6th June, resulting in changes to communication methods regarding cases.

Please read the information below carefully to ensure this transition does not impact your correspondence with us relating to your case.

  • Change of case reference number (CRN)

Previously, the HPRA market surveillance or vigilance case reference numbers were displayed as VXXXXX or MSXXXXX.

Case numbers will now be alphanumerical for example CRN00011X. HPRA will still be able to identify any closed or ongoing cases using the old reference numbers.

  • Changes to email communications

New cases will be assigned a dedicated e-mail address for example Case [email protected].

This will enable sending of case-specific communications directly to the allocated team.

E-mail correspondence sent to manufacturers from the HPRA that is relevant to the case will come from this dedicated e-mail address.

Please consult with IT departments within the organisation to ensure that e-mails of this nature are not blocked.

Please note that vigilance reports should continue to be submitted through


Clinical investigation on medical devices: four decrees published in Official Gazette | 16 June 2023

Two ministerial decrees were recently published in the Official Gazette on June 13, 2023, in relation to administrative procedures for clinical investigations of medical devices. The first decree focuses on applications for clinical investigation of devices that are either not CE marked or are CE marked but used outside their intended purpose.

The second decree pertains to communications regarding clinical investigations on CE-marked devices used within their intended purpose. These decrees are in accordance with legislative decree n. 137/2022, which aligns national legislation with regulation (EU) 2017/745.

Effective from July 13, 2023, the decrees share a similar structure and aim to:

  • Identify the eligible entities to submit applications and communications for clinical investigations.
  • Clarify the procedures for submitting requests and communications related to clinical investigations.
  • Define the methods and timelines for obtaining the national-level opinion from an Ethics Committee.
  • Establish the means for communicating the initiation of investigations.

Additionally, two other ministerial decrees were published in the Official Gazette on June 14, 2023. The first decree focuses on ensuring the independence, transparency, and impartiality of the parties involved in handling clinical investigation requests.

It aims to prevent conflicts of interest and undue influence, mandating specific declarations and requiring abstention in cases of conflicts of interest.

The decree also allows for the involvement of experts with scientific and professional qualifications from research institutions, healthcare providers, or universities to evaluate survey questions.

The second decree addresses the requirements of suitable facilities for conducting clinical investigations aimed at demonstrating medical device conformity. It establishes that the assessment of facility suitability will be based on declarations submitted by the facilities’ legal representatives.

Moreover, the decree permits remote testing of devices using digital technologies under specified conditions. Both decrees also implement provisions outlined in legislative decree n. 137/2022 (paragraphs 5 and 8 of article 16).

Initiation of SMEMDN project to update EMDN | 19 June 2023

TThe SMEMDN project, funded by the EU4Health 2022 Work Program, has officially begun. It aims to support and maintain the European Medical Device Nomenclature (EMDN) required by EU regulations for medical devices.

The EMDN is based on the Italian classification system, the National Classification of Medical Devices (CND), which was adopted by the European Commission in 2019.

The project will last for 36 months and involves the Italian Ministry of Health and the Friuli Venezia Giulia Region. Its main objectives are to assist the European Commission in updating the EMDN, facilitate communication with member states and stakeholders regarding the nomenclature, provide tools to support the use of the EMDN, and collaborate with the World Health Organization.

The project follows a participatory approach, involving international stakeholders in maintaining and improving the EMDN. It considers technological advancements and evolving markets for medical devices. The EMDN has been used for medical device registrations in the European database for medical devices since October 2021.


Updated Guidance on Borderline Products | 20 June 2023

Certain products can be challenging to categorize as they may share similarities with medicines, such as medical devices, cosmetics, food supplements, or biocidal products. These products are referred to as borderline products until their classification is determined.

The MHRA plays a crucial role in assessing the nature of these products. It determines whether a product meets the criteria for classification as a medicinal product and provides guidance on its status. Additionally, the MHRA evaluates whether a product should be classified as a medical device or falls under a different category. The guidance was updated on 20th June 2023.

Software and AI as a Medical Device Change Programme | 14 June 2023

Software (and AI in particular) plays an increasingly prominent role in health systems, having a wide set of applications across health and social care. Many of these applications will be regulated as medical devices. It is increasingly important then that medical device regulation be fit for purpose, to ensure patients, public, and healthcare professionals are empowered with the best medical technology available.

This work programme will deliver bold change to provide a regulatory framework that provides a high degree of protection for patients and public, but also make sure that the UK is the home of responsible innovation for medical device software.

MHRA / HRA Coordinated Pathway | 20 June 2023

The MHRA and HRA have collaborated to establish a coordinated assessment pathway that simplifies the review process for clinical investigations with medical devices. This pathway enables parallel reviews by the MHRA and Research Ethics Committee (REC), ensuring efficient sharing of information and benefiting applicants

Regulating Medical Devices in UK | 20 June 2023

The UK medical device market is governed by the Medicines and Healthcare products Regulatory Agency (MHRA). This guidance provides information on the UK system, including for:

  • Getting your device certified
  • Conformity marking your device.
  • Registering your device with the MHRA

This guidance is divided into sections on the different rules that apply in Great Britain, Northern Ireland and the EU. Great Britain is England, Wales and Scotland.

Extended acceptance of CE marked medical devices on the Great Britain market | 01 July 2023

An extended timeframe for the acceptance of CE-marked medical devices on the British market is now implemented. This means that medical devices with the CE mark will be accepted on the British market after the current deadline of 30 June 2023.

As a result, CE marked medical devices may be placed on the Great Britain market to the following timelines:

  • General medical devices (MDs) compliant with the EU medical devices directive (EU MDD) or EU active implantable medical devices directive (EU AIMDD) with a valid declaration and CE marking can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2028
  • In vitro diagnostic medical devices (IVDs) compliant with the EU in vitro diagnostic medical devices directive (EU IVDD) can be placed on the Great Britain market up until the sooner expiry of the certificate or 30 June 2030, and
  • General medical devices, including custom-made devices, compliant with the EU medical devices regulation (EU MDR) and IVDs compliant with the EU in vitro diagnostic medical devices regulation (EU IVDR) can be placed on the Great Britain market up until 30 June 2030.


Medicinal Products with a Medical Device Component | 13 June 2023

Combination products are medicinal products with a medical device component. In the case of non-separable combinations (“integral” and “copackaged”), the combination product is not subject to the Medical Devices Ordinance. However, the medical device component must meet the basic safety and performance requirements according to Annex I EU-MDR.

For combination products (“integral” and “co-packaged”) currently authorized in Switzerland whose medical device component documentation also includes EU conformity certificates (CE certificates) for medical devices, the regulations on the validity of certificates set out in the changes to the EU-MDR will also apply.

If a new certificate is issued in accordance with EU-MDR, a separate application for variation does not have to be submitted. These certificates can be submitted together with another quality variation as an editorial change. If no other quality variations are planned in the near future, these certificates can also be submitted as a B.IV.1.z, type IA variation.

However, if the variation or new issuance of a certificate is the result of a significant change to the medical device component which affects/may affect the design or intended purpose or the quality, efficacy or safety of the combination product under medicinal product legislation, a separate application for variation must be submitted.


Guidance on Premarket submission for Device Software Functions | 10 April 2023

FDA has released a new guidance document on the Content of Premarket Submissions for Device Software Functions. This guidance document is intended to provide information regarding the recommended documentation for premarket submissions for FDA’s evaluation of the safety and effectiveness of device software functions, which are software functions that meet the definition of a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).


New guidance published on manufacturer evidence for IVD medical devices | 20 June 2023

TGA no longer accepts ISO 13485 certificates to support applications for new In Vitro Diagnostic (IVD) medical devices, except if the manufacturer made a Declaration of Conformity under the EU IVD Directive before 26 May 2022.

IVD medical devices that are already approved for supply based on ISO 13485 certificates will need to transition to another form of acceptable manufacturer evidence once the certificate expires, to continue to supply in Australia.

This guidance helps sponsors identify the actions they must take to transition to new manufacturer evidence and ensure ongoing regulatory compliance.


HSA’s SRA status for in vitro diagnostic medical devices (IVD)| 16 June 2023

The Health Sciences Authority (HSA) has been recognized by the WHO as the Strict Regulatory Authority (SRA) for high-risk In Vitro Diagnostic Devices (IVD).

This recognition allows HSA-registered IVDs to undergo an abbreviated WHO prequalification assessment, facilitating rapid access to international markets. HSA’s SRA status reflects its commitment to maintaining quality standards and improving public health.


Transition period for the use of electronic medical device certificates | 22 May 2023

The Medical Device Authority (MDA) will implement the use of electronic medical device registration certificates starting May 2, 2023 . The establishment can download the medical device registration certificate from the [email protected]+ system once the application is complete (status complete ) and the registration fee has been paid.

The use of electronic medical device registration certificates will be fully implemented from 1 January 2024 and no more physical medical device registration certificates will be issued by MDA.


Anvisa publishes new medical device import manual | 22 June 2023

The new Manual for Importing Medical Devices is available on Anvisa’s portal . The document aims to guide importers on the rules for submission and procedures for analyzing import processes .

The subjects are organized into topics , which help consultation on the regularization of companies and products, procedural instruction and analysis and inspection procedures . The specific legislation and situations applicable to each topic are also indicated.

This publication is not intended to replace the guidelines on petitioning for the import process already published by the Agency or the manual available on the Siscomex Portal . The idea is to complement this information on specific aspects of consent to import medical devices in the context of Anvisa.

Users will be able to evaluate requests for medical devices | 20 June 2023

Those who use the medical device application service will be able to evaluate the process with Anvisa. The implementation of the evaluation will start from this Wednesday ( 21/6). The functionality is being gradually expanded to all requests made through the Solicita system , with the sanitizing area being the pioneer in implementing the service.

At the end of each request process, a link is provided for the user to send their opinion about the service request in the Request. The purpose of the assessment is to improve the provision of services offered by the Agency .

 Another improvement that will be implemented is the categorization of services, to facilitate the location of the desired subjects, in addition to the other filters already available. The system will display only the subjects available for the selected process, reducing the possibility of errors in the petitions.

In addition, it will be possible to consult which service is associated with each subject and which other services are related (list of parent and child services) in the consultation tool available at

If the user identifies any lack of subject or service, he is requested to contact the appropriate area and describe the problem.



EU Proposes Amendments to Use Restrictions on D4, D5, D6 in Cosmetics | 27 June 2023

On June 22, 2023, the EU introduced new amendments to Annex XVII to Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) through a draft regulation notified to WTO.

This draft proposes to further restrict the use of Octamethylcyclotetrasiloxane (D4), Decamethylcyclopentasiloxane (D5), and Dodecamethylcyclohexasiloxane (D6) in cosmetics as well as other consumer and professional products. It is currently open for comment until August 21, 2023.

EU to Implement a Union-wide Ban on PFHxA in Cosmetics | 21 June 2023

On June 19, 2023, the EU notified WTO of a draft regulation aiming at amending the Annex XVII to Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).

This draft proposes to prohibit the use of Undecafluorohexanoic Acid (PFHxA), its salts, and related substances in various applications, including cosmetics. It is currently open for comment until August 18, 2023.

EU to Adopt Changes to Use Requirements for cosmetic ingredients | 14 June 2023

The EU introduced 11 changes to the ingredient lists in Cosmetics Regulation, including:

1) Adding one prohibited ingredient, and eight restricted ingredients;

2) Amending the use requirements for two permitted preservatives.

On June 8, 2023, EU notified WTO of a draft regulation that aims at revising the ingredient lists in Regulation (EC) No 1223/2009 (Cosmetics Regulation). The draft proposes to prohibit and restrict the use of certain cosmetic ingredients respectively, following the opinions from the Scientific Committee on Consumer Safety (SCCS), and is open for comments until August 7, 2023.


Canada Bans Cosmetic Animal Testing | 27 June 2023

On 27th June 2023 , the Honourable Jean-Yves Duclos, Minister of Health, announced that the Government of Canada has banned the cruel and unnecessary testing of cosmetic products on animals in Canada, representing a major step forward in supporting animal welfare by reducing our reliance on animal testing, while ensuring health and safety.

With the passing of Bill C-47, Budget Implementation Act, 2023, No. 1, the Food and Drugs Act (FDA) has been amended to ban cosmetic animal testing. The new legislative changes mean that in Canada, companies will no longer be allowed to test cosmetic products on animals or sell their cosmetics that rely on animal testing data to establish safety.

The practice of testing cosmetics on animals has significantly decreased worldwide and was rarely conducted in Canada. By implementing these changes, Canada is aligning with the global shift toward ethical cosmetic testing by joining other countries, including all European Union countries, Australia, the United Kingdom, and South Korea, that have already taken measures to prohibit cosmetic animal testing.

Beyond cosmetics, Health Canada is working with the international scientific and regulatory community to develop, validate and implement effective alternatives to animal testing.

This includes providing continued leadership and contributions to the work of various committees and organizations, such as the Organisation for Economic Co-operation and Development (OECD) and the International Cooperation on Alternative Test Methods (ICATM).


China NIFDC Consults on Updates to Prohibited Ingredients and Toxicological Test Methods for Cosmetics | 14 June 2023

On June 12, 2023, China’s National Institutes for Food and Drug Control (NIFDC) initiated a public consultation on proposed updates to the Inventory of Prohibited Ingredients for Cosmetics, along with the introduction of test methods for cosmetic ingredients. Interested parties are invited to provide their feedback and suggestions until July 15, 2023, by submitting the Feedback Form via email to [email protected].

Additionally, the consultation highlights the introduction of seven draft test methods for the toxicological test of cosmetic ingredients, which are developed according to Organization for Economic Co-operation and Development (OECD) guidelines. Notably, the draft U937 Cell Line Activation Test is a new animal testing alternative specifically for skin sensitization. It complements the existing skin sensitization test method in the Safety and Technical Standards for Cosmetics 2015 and aligns with the global movement towards cruelty-free practices.

China NIFDC Clarifies Detailed Registration Requirements for Special Cosmetics and New Cosmetic Ingredients | 26 June 2023

On June 5, 2023, China National Institutes for Food and Drug Control (NIFDC) released nine guidelines pertaining to the registration of Chinese domestic and imported special cosmetics, as well as high-risk new cosmetic ingredients (NCIs). 1 These guidelines provide clear details and time limits for the first registration, registration change, registration renewal and registration cancellation applications, which are highly informative for enterprises seeking guidance.

The latest guidelines are titled as follows:

  • Guidelines for the Approval of Registration of New Cosmetic Ingredients with High Risks
  • Guidelines for the Approval of Registration Change of Chinese Domestic Special Cosmetics
  • Guidelines for the Approval of Initial Registration of Chinese Domestic Special Cosmetics
  • Guidelines for the Approval of Registration Renewal of Chinese Domestic Special Cosmetics
  • Guidelines for the Approval of Registration Cancellation of Chinese Domestic Special Cosmetics (Cancellation upon Application)
  • Guidelines for the Approval of Registration Change of Imported Special Cosmetics
  • Guidelines for the Approval of Initial Registration of Imported Special Cosmetics
  • Guidelines for the Approval of Registration Renewal of Imported Special Cosmetics
  • Guidelines for the Approval of Registration Cancellation of Imported Special Cosmetics (Cancellation upon Application)

The main content of these guidelines include:

  • Administrative licensing item name and code
  • Sub-item name and code of administrative licensing
  • Business items that need to be handled
  • Competent authority
  • The Guidelines’ establishment and implementation basis
  • Executive agency
  • Approval levels
  • Types of administrative licensing items
  • Licensing conditions
  • Application documents
  • Intermediary services
  • Approval procedures
  • Acceptance and approval time limit
  • Fees
  • Administrative license


India Proposes Amendments to Cosmetics Rules 2020 | 05 June 2023

The proposed changes cover terminology modifications, the introduction of new rules, the relaxation of certain regulatory requirements, and various other adjustments.

On May 17, 2023, the Ministry of Health and Family Welfare of India initiated a public consultation on proposed amendments to the Cosmetics Rules 2020, with the goal of improving the regulation and quality control of cosmetics in India.

The consultation period lasts 45 days, during which stakeholders are encouraged to provide feedback and suggestions to the Ministry, either by mail (see Notes at the end of the article for detailed address) or by email to [email protected].


Thailand Cosmetics Regulation Update: Release of Prohibited ingredient list | 30 June 2023

Thailand has recently implemented changes in the cosmetics regulations, introducing a new list of prohibited ingredients and updating the requirements for permitted preservatives. The latest updates now align Thailand’s regulations with the latest ASEAN Cosmetic Directive revisions.

On June 22, 2023, the Ministry of Public Health of Thailand (MOPH) issued three notices through the 140th Government Gazette of 2023, detailing the regulatory revisions pertaining to prohibited ingredients and permitted preservatives in cosmetics.

These notices officially came into effect on June 23, with a transition period applying to some rules.


List of Updated ISO standards for June 2023

  • BS EN ISO 19979:2023 Ophthalmic optics. Contact lenses. Hygienic management of multi-patient use trial contact lenses (ISO 19979:2018)
  • BS EN IEC 61676:2023 Medical electrical equipment. Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology.
Software As a Medical Device and Its Clinical Evaluation

Software As a Medical Device and Its Clinical Evaluation

As technology advances across all healthcare fields, Software plays a significant role in all products. It is widely integrated into digital platforms serving both medical and non-medical purposes. Medical device software is one of three types of Software related to medical devices.

The other two types of medical device software include Software that is an integral part of the medical device (medical device software) and Software used in manufacturing or maintaining the medical device.

Software as a Medical Device Introduction

The International Medical Device Regulators Forum (IMDRF) defines SaMD as “software intended for one or more medical purposes that perform those purposes without being part of a hardware medical device.”

FDA defines SaMD as “Software that meets the definition of a device in 181 section 201(h) of the FD&C Act and is intended to be used for one or more medical purposes without being part of a hardware device.”

The use of SaMD is experiencing a steady rise, with its application extending to various technology platforms such as medical device platforms, commercial “off-the-shelf” platforms, and virtual networks, among others.

This kind of software was previously referred to as “standalone software,” “medical device software,” or “health software” by industry professionals, international regulators, and healthcare providers, often leading to confusion with other software categories.

How Do I Know if My Product is SaMD?

As a member of the International Medical Device Regulatory Forum (IMDRF), the FDA recognizes the structural similarity between the two organizations’ definitions of SaMD. The definitions provided by the FDA and IMDRF highlight two criteria that must be satisfied for software to be designated as SaMD.

To evaluate if the Software is a medical device, it is important to assess its compliance with the regulatory authority’s definition. The IMDRF emphasizes that the Software must be “intended for one or more medical purposes”. On the other hand, the FDA references FD&C, or the Federal Food, Drug, and Cosmetic Act, Section 201(h),  which outlines the definition of a device. This section defines a device as follows: 

According to Section 201(h) of the FD&C, a device encompasses various articles such as tools, implements, instruments, machines, devices, appliances, in vitro reagents and other similar or related items, including components and accessories.

  1. An article must also be legally recognised in the National Formulary, the United States Pharmacopoeia, or an analogous revision in order to meet the requirements of Section 201(h) of the FD&C Act’s definition of a device.     
  1. The product is intended to be used in the diagnosis of disease or other conditions as well as in the treatment, mitigation, treatment, or prevention of disease in people or animals, according to the definition of a device under FD&C Section 201(h).   
  1. In addition, a product must be intended to change any structure or function of the human or animal body without compromising its primary function for it to qualify as a device under Section 201(h) of the FD&C Act.

In addition, the definition of a device in Section 201(h) of the FD&C Act states that it must not achieve its primary purpose by chemical action in or on the human or animal body, nor must it rely on metabolism to achieve its purpose.

Note that the term “device” does not include software features that are excluded by Section 520(o). To apply this definition, it is essential to establish the intended use and indications for the use of your product. To refresh your understanding,

  • The intended use of a device refers to its designated purpose or the specific function for which the device is intended to be utilised. In other words, it defines the intended or intended application of the device
  • Indications for use pertain to the diseases or conditions that a device is designed to diagnose, treat, prevent, cure, or mitigate. These indications specify the target patient population and provide insights into why the device would be used on individuals with those diseases or conditions

Once the intended use and indications for the use of your product are defined, the second and third points in the FDA’s definition of a medical device will help determine whether your product falls under the regulatory scope of a medical device. These criteria will clarify whether your product meets the requirements for medical device regulation.

If you intend to market your software product in the United States, I recommend carefully reviewing the FDA’s guidance on Policy for Device Software Functions and Mobile Medical Applications.

This guidance provides valuable insights into the specific software functions that the FDA classifies as medical devices and functions that are not considered medical devices and, therefore, not subject to FDA regulation. Familiarizing yourself with this guidance will provide you having a thorough awareness of the regulatory environment for software products in the medical field.

If you’re still unsure about whether your product qualifies as a medical device, contacting the FDA directly for clarification is safest. Contacting the FDA now will provide reliable advice and ensure you receive accurate information tailored to your specific product and situation.

Is My Software Considered SaMD or SiMD?

When a product is found to fit the definition of a medical device, the second portion of the IMDRF and FDA definition of software as a medical device (SaMD) must be taken into account.

  1. According to the IMDRF definition, Software must be used for its intended purpose only and must not be an integral part of a physical medical device.  
  1. According to the IMDRF, the FDA makes it clear that Software as a Medical Device (SaMD) is not a part of a hardware device and is instead intended for standalone usage for one or more medical purposes.

This further limit the scope of Software as a medical device (SaMD), as the Software used to operate or control a hardware device does not fulfil the requirements to be categorised as a SaMD. Instead, this type of Software is referred to as SiMD or “software in a medical device.”

Here are some examples of Software that assist in operating a hardware medical device, which falls under the category of Software in a Medical Device (SiMD) and not Software as a Medical Device (SaMD):

  1. Software that controls the inflation or deflation of a blood pressure cuff
  2. Software that controls the delivery of insulin on an insulin pump
  3. Software used in the closed-loop control of a pacemaker.

“firmware,” or “micro-code,” indicating their classification as SiMD rather than SaMD.

To qualify as SaMD, a product must have standalone Software that independently carries out the functions defining it as a medical device, distinct from any associated hardware. The IMDRF guidance on “Possible Framework for Risk Categorization and Corresponding Considerations” further provides additional insights and clarifications regarding the SaMD definition.

1. SaMD is a medical device, including in-vitro diagnostic (IVD) medical devices.

2. SaMD can run on general-purpose computing platforms not specifically designed for medical purposes.

3. “Without being part of” means the Software is unnecessary for a hardware medical device to achieve its intended medical purpose.

4. Software intended to drive a hardware medical device does not meet the definition of SaMD.

5. SaMD can be combined, such as being integrated as a module, with other products, including medical devices.

6. SaMD can interface with other medical devices, including hardware medical devices, other SaMD software, and general-purpose Software.

7. Mobile apps that meet the defined criteria are considered SaMD.

Although it is crucial to distinguish between Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD), both types of Software adhere to many common standards for development, including the global standard for software lifecycle procedures is IEC 62304.  lifecycle processes.

If your Software falls under the category of SiMD, you will still find the guidance documents and standards outlined in this guide valuable and applicable.

What are Some Examples of SaMD?

1. Software that enables a mobile device to view diagnostic images from MRI, ultrasound, or X-ray scans.

2. Software that utilizes image processing techniques to aid in detecting breast cancer.

3. Software that diagnoses a medical condition by analyzing data from the tri-axial accelerometer on a smartphone.

4. Software that collects real-time patient data monitored by a healthcare professional and utilized to develop treatment plans.

Clinical Evaluation

Clinical evaluation is a methodical and well-organized process that creates clinical evidence by continuously creating, collecting, analyzing and evaluating clinical data on SaMD to create clinical trials that review the clinical context and performance indicators of SaMD.

The quality and scope of the clinical assessment is based on the SaMD function for the clinical objective, which also ensures that the SaMD   score is clinically valid and can be used consistently and predictably. 

3 Clinical Evaluation Software

To qualify the software, the following three criteria must be met. To qualify your software, you must meet the three criteria outlined below.

  • Valid Clinical Association of a SaMD
  • Analytical/Technical Validation of a SaMD
  • Clinical Validation

1. Valid Clinical Association of a SaMD

Verifying that your software’s output corresponds to the targeted clinical conditions is the main goal here. Use of secondary data analysis, clinical trials (new data generated), professional society guidelines, original clinical research, literature searches, and/or secondary data analysis are all options for carrying out that task. All SaMD should show a reliable clinical association.

2. Analytical/Technical Validation

Does your software correctly process input data to generate accurate, dependable, and precise output data?” is the question we are attempting to answer in this context. Develop supporting documentation that demonstrates your SaMD’s output met your expectations in terms of technicality.

This action is being assessed by a manufacturer as part of the software’s validation and verification phase (V&V).

3. Clinical Validation

SaMD has been evaluated in your target population and for your intended use; users are able to achieve clinically significant results through consistent and dependable use.