Blogs
Directive (EU) 2019/904 on the reduction of the Impact of certain Plastic Products on the Environment
Introduction Directive 2019/904 aims to mitigate the environmental and health impacts of specific plastic products, particularly in aquatic environments, while fostering the transition towards a circular economy through innovative and sustainable practices. It...
Iraq Medical Device Registration: KIMADIA Guidelines and Requirements
Navigating Medical Device Registration with Iraq's Regulatory Authority: KIMADIA Guidelines and Requirements Regulatory Authority: State Company for Marketing Drugs and Medical Appliances (KIMADIA) "Kimadia" refers to the Iraqi State Company for Marketing...
License Transfer for Medical Device to New Sponsors from Existing License Holders
License transfer for medical devices is a crucial aspect of the regulatory landscape governing the manufacturing and distribution of medical products. It allows existing license holders to transfer the rights to manufacture and market a specific medical device to a...
License Transfer for Medical Device to new Local AR – New Zealand
Medical devices play a crucial role in healthcare by diagnosing, treating, and monitoring various medical conditions. These devices are designed and manufactured by companies that must obtain licenses to sell their products in different markets. When a company wants...
The Role of Notified Bodies in Assessing Clinical Evaluation Reports (CERs) under EU MDR
Clinical evaluation is a continuous procedure that happens at every stage of a medical device's life cycle. It is typically carried out initially in the course of developing a medical device to determine what data must be produced to gain access to the market. The...
Navigating Regulatory Requirements: Compliance Essentials for Post-Marketing Surveillance
The medical device industry thrives on innovation, but ensuring patient safety remains paramount. Regulatory compliance, particularly in post-marketing surveillance (PMS), is crucial for safeguarding patients and maintaining market access. This article explores the...
Global Market Access Strategies for Software as a Medical Device (SaMD)
Introduction In the ever-evolving realm of healthcare technology, Software as a Medical Device (SaMD) stands out as a transformative force, offering personalized solutions tailored to individual patient needs. As demand surges for SaMD solutions worldwide,...
Ensuring Compliance and Quality: The Role of CE Marking in Safeguarding Patient Safety
The CE marking signifies a medical device's adherence to stringent European Union (EU) safety regulations. This compliance process, known as CE marking compliance for patient safety, is critical in ensuring the quality and effectiveness of medical devices. By...
EU MDR Unveiled: What You Need to Know About Medical Device Regulation in Europe
Introduction about Medical Device Regulation in Europe Introducing the Medical Device Regulation in Europe addresses several challenges. It aims to enhance medical device regulation in Europe to ensure a higher level of safety and effectiveness. The need for the MDR...
Understanding the Key Responsibilities of an Authorized Representative in the Medical Device Industry
In the complex ecosystem of the medical device industry, ensuring compliance with regulatory standards and navigating the path to market access are crucial tasks. Amidst this complexity, one key player stands out: the Authorized Representative (AR). ARs are recognized...
Staying Vigilant: Best Practices for Post-Market Surveillance under EU MDR
As medical device manufacturers navigate the landscape of post-market surveillance (PMS) under the European Medical Device Regulation (EU MDR), maintaining vigilance and adherence to best practices is crucial. Effective PMS not only ensures ongoing product safety and...
Strategic Approach to Compliance: Mastering the Quality Management System (QMS) in EU MDR
QMS (Quality Management System) and ISO 13485 A Quality Management System is defined by ISO 13485 as a set of processes, procedures, and responsibilities for achieving quality policies and objectives in a medical device manufacturing organisation. It is a structured...
OMC Medical to Showcase Global Market Access Solutions at KIMES 2024
Book time with Gayathri Ganesan: KIMES Exhibition OMC Medical Set to Attend KIMES, Invites Participants to Meet at UK Pavilion for Uninterrupted Market Access Solutions SEOUL, SOUTH KOREA - February 21, 2024 - OMC Medical, a leading provider of...
Navigating Healthcare with Implant ID Cards: What You Need to Know?
Implant ID Cards Introduction Implanted medical devices, from life-saving pacemakers to pain-relieving joint replacements, are transforming how we manage health conditions. However, carrying these technological marvels within our bodies presents a unique challenge:...
Beauty Beyond Borders: A Comprehensive Guide to Cosmetic Regulations in Saudi Arabia
In recent years, the beauty and cosmetics industry has witnessed exponential growth worldwide, breaking down geographical barriers and creating a global marketplace. One country that has embraced this transformative trend is Saudi Arabia, where the beauty industry has...
Navigating Biologic Product Registration in Thailand: TFDA Requirements, Procedures, and Validation Process
TFDA Requirements for Summary Product Characteristic (SPC) Name of the Medical Product Qualitative And Quantitative Composition Pharmaceutical Form Clinical Particulars Therapeutic indications Posology and method of administration Contraindication Special warnings and...
ARAB Health Event – Unlocking Global Markets
The ARAB Health Event is back and ready to pave the way for groundbreaking advancements in healthcare! This year, we invite you to embark on a journey of discovery as we delve into the theme of "Unlocking Global Markets." This extraordinary event promises to be a...
Regulation (EU) 2017/746 (IVDR): MDR IVDR Amendment Jan. 2023
Introduction Recent amendments to Regulation (EU) 2017/745, also known as the Medical Devices Regulation (MDR), have introduced significant changes to the timelines and conditions for placing certain medical devices on the market or putting them into service. This...
Overhauling Drug Registration: The Indonesian Food and Drug Authority’s Progressive Amendment
Drug Registration - The Indonesian Food and Drug Authority (BPOM) plays a crucial role in ensuring the safety and efficacy of pharmaceuticals within the Republic of Indonesia. In 2019, the BPOM made a significant stride towards enhancing public services and aligning...
Comprehensive Guide to Pharmaceutical Registration in Indonesia: BPOM, Regulations, and Approval Pathways
Territory: Southeast Asia Official Language: Indonesian/English Regulatory Authority Name: Badan Pengawas Obat dan Makanan (BPOM) Regulatory Authority website: https://www.pom.go.id/ Mail ID: [email protected] Regulation Name:...
Comprehensive Guide to Medicinal Product Registration in Armenia: Criteria, Procedures, and Quality Standards
MoH: Armenia Ministry of Health MoH website: https://www.gov.am/en/structure/1/ Regulatory Authority: Scientific centre of drug and medical technology expertise Link for Regulatory Authority: https://www.pharm.am/index.php/en/ Overview The registration of medicinal...
Streamlining Pharmaceutical Registration in Argentina: A Comprehensive Guide to Navigate the Regulatory Process for Drug Approval
MoH: Ministry of Health of Argentina MoH website: https://www.argentina.gob.ar/salud Regulatory Authority: The National Administration of Drugs, Food and Medical Technology Link for Regulatory Authority: https://www.argentina.gob.ar/anmat Applicable Regulation: DECREE...
Demystifying Pharmaceutical Registration in Albania: Your Ultimate Guide to Medicine, Drug, and OTC Product Approval Processes
MoH: The Ministry of Health and Social Protection. MoH website: https://shendetesia.gov.al Regulatory Authority: National Agency for Medicines and Medical Devices (AKPBM) Link for Regulatory Authority: https://akbpm.gov.al/ Medicine/Drug/OTC/Pharmaceutical...
Streamlining the Afghanistan Drug Registration: A Comprehensive Guide for Approval and Compliance
MoH: Ministry of Public Health MoH website: https://moph.gov.af/en Regulatory Authority: Afghanistan Food and Drug Authority National Medicine and Health Products Regulatory Authority (NMHRA) Link for Regulatory Authority: https://afda.gov.af/index.php/en/market-0...
How to place a device in the Northern Ireland market?
Under certain conditions, the UK MDR 2002 mandates that you notify the MHRA at the time of your device's initial sale in Northern Ireland. The manufacturer's location, the Authorised Representative's location, and the device class determine the specific criteria. ...
UK Medical Device Registration Process
How to do medical device registration with the Medicines and Healthcare products Regulatory Agency (MHRA)? The following steps are followed to register a medical device in the UK market as per the news released by MHRA on 10 Jan 2024. What can be...
Implementation of Medical Devices future Regime
🌐 Exciting News in the Healthcare Sector! 🏥 The UK Government is making significant strides in shaping the future regime for the implementation of medical devices. 🚀 🔬 The commitment to advancing healthcare technology is evident as the government sets the stage for a...
Understanding Borderline Cosmetics in the EU
Understanding the distinctions between product classes within the European cosmetics landscape can be complex and ambiguous, often requiring input from authoritative bodies. Certain products may share similarities but fall under different regulatory frameworks. When...
What makes Switzerland significant for Medical Device Manufacturers?
Switzerland is a premier destination for medical device manufacturers relying on sophisticated micromanufacturing or advanced precision techniques. This appeal is evident in Switzerland's choice of EMEA headquarters for industry leaders. The country boasts one of the...
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...
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...
Establish a Medical Device Startup Company
Medical device startups play an essential role in revolutionising 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.
Software As a Medical Device and Its Clinical Evaluation
Software as a medical device (SaMD) refers to a class of medical software that performs one or more medical tasks independently of a physical medical device. It can interface with other medical equipment or software or be utilised with non-medical computer platforms like smartphones. It may be used for a number of objectives, including illness detection, diagnosis, treatment, or prevention. The quality of life for patients and providers can be enhanced through its interactions with data. Regulation is necessary for SaMD since it is a novel and creative technology that must be safe.
Vigilance Terms and Concepts as Outlined in the Regulation (EU) 2017/745 on Medical Devices
According to European Union Medical Device Regulation (EU MDR) the term “Vigilance” is the identification, reporting and trending of serious incidents and the conduct of safety-related corrective actions (Market surveillance and vigilance). An ‘incident’ as per...
Technical Documentation Requirements MDD Vs MDR
Check out the difference between MDD vs MDR MDD vs MDR MDD A MDD Technical documentation must include: A general device description, including any information on any planned variants Design drawings, details on the planned method of manufacture, diagram of components,...
Safety Reporting on Clinical investigation
Under EU MDR 2017/245 Article 73, the sponsor shall report to all member states about the clinical investigations undertaken by the medical devices through an electronic system in case of any serious adverse events, device deficiency which leads to adverse events or...
eSTAR Pilot program by Health Canada & US FDA
eSTAR (electronic Submission Template and Resource) is an initiative launched by the US Food and Drug Administration in February 2020. It is a free, interactive PDF Form that provides assistance to the applicants in preparing the CDRH medical device submission for...
MDCG Guidance for Manufacturers of Class I Medical Devices
This document is intended to serve as guidance for Class I medical device manufacturers (excluding custom-made devices) that sell products bearing their name or trademark on the Union market in order to comply with MDR requirements. This guidance should also apply when an importer, distributor, or any other legal entity takes on the obligations owed by manufacturers.
Post Market Surveillance Plan – FDA
Post Market surveillance requirements are set out in Title 21 Code of Federal Regulation (CFR) Part 822. This article aims to put an adequate post-market surveillance authority into practice to increase the possibility that post-market surveillance (PMS) plans will result in valuable data gathering.
Registration of Legacy Devices in EUDAMED
Legacy Devices are the medical devices covered by a valid Directive certificate under Directive 93/42/EEC or Directive 90/385/EEC and continue to be placed on the market after the date of application of Regulation (EU) 2017/745 (MDR). Those devices should be...
Cosmetics Product Recall under FDA
Title 21 of the Code of Federal Regulations (CFR), section 7.3(g), describes a recall as a firm's removal or correction of a marketed product that FDA judges to be in violation of the laws we administer and against which the FDA would start legal action, such as...
Vigilance in EU MDR
MDR Vigilance is a strategy for gathering information on post-market adverse medical device incidents. Vigilance System strives to lessen the likelihood of incidents while also increasing patients’, healthcare provider, and other user protection. Chapter VII Section 2 of the EUMDR contains the vigilance requirements (Articles 87 to 92).
EU IVDR’s First certification for the type of IVD and Notified Bodies Procedures
The first certification for the type of device means that the device has no similar intended use with the products placed under the EU market.
EU MDR Market Surveillance Activities
Market surveillance is the activity carried out by the competent authorities according to Article 93 of MDR 2017/745 to ensure that products on the market comply with the relevant laws and regulations and with the current EU health and safety requirements. Maintaining...
MDCG 2022-16 Guidance for Authorised Representatives (AR)
Article 11 of the Regulation (EU) 2017/745 on medical devices (MDR) and EU Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) outlines the obligations and responsibilities for the Authorised Representatives (AR). Key points are taken for Authorised...
FDA’s Adverse Event Reporting for Cosmetics
The FDA keeps an eye on cosmetics sold on the market to make sure people may use them safely. When a consumer, manufacturer, or medical practitioner submits an adverse event report (AER), FDA may learn of a safety concern. Any issue that occurs after using a cosmetic product might be considered an adverse event.
Animal Testing for Cosmetics
The term "animal testing" refers to procedures carried out on living animals for research into basic biology and diseases, evaluating the efficacy of new pharmaceuticals, and testing the safety of consumer and industry products such as cosmetics, household cleaners,...
Manual on Borderline and Classification of Medical Devices
A manual on borderline products has been released by the Medical Device Coordination Group (MDCG), an advisory group of the European Commission in charge of the regulatory framework for medical devices. The method to determine a product’s regulatory status when it is questionable is thoroughly described in the document. The guidance, in particular, specifies the elements to be taken into account when reaching such a conclusion and offers recommendations.
The combination of medical devices and medicinal products based on MDCG 2022-5
Borderline medical products are the products which are a combination of medical devices and medicinal products which are intended to treat, prevent, diagnose diseases, or change physiological function.
EU Notified Body
A notified body is an independent organisation designated by an EU country to assess the conformity of products before being placed on the market. Under EU MDR 2017/745, the notified body is also called a conformity assessment body. A conformity assessment body...
MHRA Guidance on Stand-alone Software Medical Devices
Medical device apps are increasingly growing these days. MHRA has issued new guidance on the stand-alone software medical devices, including apps. This guidance is a crucial document for manufacturers and users of such medical devices.
IMDRF guide on Post Market Clinical Follow-up Studies (PMCF)
PMCF is a continuous process that updates the manufacturers’ clinical evaluation during the Post-market surveillance. They must collect user feedback, clinical data, and all other clinical experiences.
Product Liability Insurance for Medical devices
Medical devices are subject to product defects. These product defects arise due to design, manufacturing or even a failed instruction. These defects can cause risks to patient, and they can in turn sue the manufacturer for this.
Article 61 Clinical Evaluation in the EU MDR
Manufacturers must plan, carry out, and document a Clinical Evaluation in order to comply with the general safety and performance standards outlined in Annex I, as per Article 61. Clinical evaluation is a series of ongoing activities that use scientifically reliable techniques for the evaluation and analysis of clinical data in order to confirm the safety, clinical performance, and/or effectiveness of the medical device when used in accordance with the manufacturer’s instructions.
MEDDEV Guidelines for Clinical Evaluation EU MDR
During the conformity assessment, the manufacturer must submit the complete information material (labelling, IFU (Instructions for Use), any promotional materials and other relevant documents), Clinical evaluation plan & report with the available clinical data,...
The ‘Blue Guide’ on EU product rules implementation 2022
The amended ‘Blue Guide’ on the application of the product rules 2022’ (“Blue Guide”) was released by the European Commission on June 29, 2022. The Blue Guide allows a better understanding of EU product regulations and their uniform and coherent application across...
Risk Management of medical devices under MDR
All medical devices are associated with inherent risks of some level. It is imperative to understand the medical device's specific risks to a patient. Under EU MDR 2017/745, risk management is a continuous and iterative process. Manufacturers are expected to plan,...
Cybersecurity for Medical Devices – FDA and EU MDR Perspective
Medical devices and the software of those devices are connected to several types of networks. Therefore, it is particularly important for manufacturers to consider Cybersecurity at the initial stages of the development.
Cybersecurity for medical devices in Europe
Cybersecurity for Medical devices is advancing, and the use of software medical devices is also increasing daily. The increased interconnection of medical devices to computer networks and technological convergence have made devices and software programmes vulnerable to mishaps. With the advancement of software as a medical device, proper regulations must establish the safety and security of medical devices.
IMDRF Regulation on SaMD
IMDRF Regulation on SaMD: As more businesses see the benefits of utilizing their software development knowledge for the benefit of patients throughout the world, the market for software as a medical device (SaMD) is expanding quickly.