The Saudi Arabian Medical device registration and approval is governed by the Saudi Food and Drug Authority, also known as the SFDA. The procedure for the introduction of a medical device in the Saudi Arabian market is called Medical Device Marketing Authorization (MDMA).
SFDA has published a guidance document, MDS-REQ-001, on Requirements for Medical Device Marketing Authorization. This guidance provides detailed information on the authorization process.
Saudi Arabian Medical Device Classification
SFDA classifies medical devices into four classes: Class A, B, C & D. Medical device classification is done as per Annex 5 of MDS-REQ-001. The medical devices are classified based on 22 rules, while the in-vitro diagnostic devices are classified based on seven rules.
Any foreign manufacturer willing to market their product in the Kingdom of Saudi Arabia (KSA) must appoint a Saudi Arabia Authorized Representative (AR). This AR will carry out all the registration formalities on behalf of the legal manufacturer.
The AR must possess an Authorized Representative License to conduct the registration activities effectively.
What is GHAD System?
The SFDA has switched to an electronic system for document submission, called GHAD System. Local and Foreign manufacturers, via an AR, should submit their application electronically in the GHAD System.
The manufacturer shall prepare a Technical Documentation, comply with and confirm the Essential Principles of Safety and Performance and maintain an effective Quality Management System (QMS).
4 Components of Saudi Arabian Technical Documentation
Other essential components of Saudi Arabian Technical Documentation will include:
1. Device Description & Specification
2. Labels and IFUs
3. Risk Management File
4. Post Market Surveillance documents
SFDA can request more information if needed which should be provided to them within ten days of request.
In addition to the above-mentioned documents, clinical evaluation is another important documentation in the Technical File. Adequate clinical evaluation studies should be carried out to prove the safety and efficacy of the medical device.
Performance evaluation studies should be carried out demonstrating scientific validity, and clinical and analytical performance. A strong clinical evaluation report, plan, and post-market clinical follow-up should support the technical file.
Post Market Surveillance
Post Market Surveillance Report is required to be submitted by manufacturers of Class A devices. This report should be generated when necessary or when requested by the SFDA. Manufacturers of Class B, C and D devices should generate a Periodic Safety Update Report (PSUR).
A PSUR should be generated annually for Class C and D devices and once every two years for Class B devices. Class D and Implantable devices should produce Summary of Safety and Clinical Performance documentation.
The SFDA also accepts electronic Instructions for Use (e-IFU). The manufacturers should provide adequate risk assessment documentation related to the e-IFU. The risk assessment should be updated in conjunction with the post-marketing activities.
For devices with a fixed expiry date, the e-IFU should be maintained for at least two years after the end of the expiry date of the last produced device. For devices with no expiry, the e-IFU should be maintained for 15 years after the previous device has been manufactured.
About OMC Medical
OMC Medical is primarily based in the UK with offices around the globe offering regulatory support to medical device manufacturers; Offering assistance starting from medical device design requirements in accordance to the relevant applicable standards, obtain relevant MoH certification or listings, establishing your devices in a new market, keep product licenses up to date until the product is End of Service (EOS).
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 flourished, reflecting the changing cultural landscape. However, with growth comes the need for regulations to ensure consumer safety and product quality.
Legal Framework for Saudi Arabia Cosmetic Regulations
Saudi Arabia has established a robust legal framework to govern the cosmetics industry, ensuring that products meet stringent safety, efficacy, and quality standards. The Saudi Food and Drug Authority (SFDA) plays a pivotal role in regulating cosmetics and ensuring manufacturers follow the Cosmetic Regulations in Saudi Arabia.
The SFDA operates in accordance with international best practices, harmonizing its regulations with global standards to facilitate the import and sale of cosmetics in Saudi Arabia.
The Law of Cosmetic Products promulgated by Royal Decree number M/49 on 18/6/1436 AH is the Cosmetic Regulation followed in Saudi Arabia.
Registration Process for Cosmetic Regulations in Saudi Arabia
One of the primary requirements for cosmetic products entering the Saudi market is registration with the SFDA. Manufacturers and distributors must submit detailed documentation about their products, including information on ingredients, formulations, and safety assessments.
This rigorous registration process guarantees that cosmetics comply with Saudi regulations and do not pose any health risks to consumers.
Notifying is listing cosmetic products in the SFDA records via the Cosmetic Notification system (eCosma) and does not mean SFDA has evaluated the product safety.
Notifying aims to create a comprehensive database of cosmetic products manufactured locally or imported by recording them in SFDA records, and the notifier (responsible person) shall comply with the validity of the information entered and the safety of the products.
Product Testing and Safety
Cosmetic products must undergo rigorous safety assessments to meet the SFDA’s standards. This includes testing for microbiological contamination, stability, and compliance with permissible limits of certain ingredients.
Manufacturers are responsible for providing evidence of product safety during the registration or notification process.
Halal Certification
Given the cultural and religious context of Saudi Arabia, the concept of Halal (permissible in Islam) is of utmost importance. Like other consumer goods, cosmetic products may undergo Halal certification to ensure they adhere to Islamic principles.
While Halal certification is not mandatory, many manufacturers seek it as a mark of authenticity and to appeal to the sensibilities of the Saudi consumer base.
Ingredient Restrictions
Saudi Arabia imposes strict regulations on the ingredients used in cosmetics. Certain substances are prohibited or restricted due to their potential harm to consumers. The SFDA maintains a list of restricted ingredients, and compliance is mandatory for all cosmetic products sold in the country.
This includes a comprehensive ban on ingredients that are considered hazardous or pose a risk to human health. The notifier (responsible person) must ensure the integrity of the entered data and the product’s safety.
Note that the Authority published a list of the banned products and restricted use in the cosmetic products in addition to a list of preservatives and colouring items allowed in the Cosmetic Products Website in accordance to article four of the Implementing Regulation of the Cosmetic Products Law.
Labelling Requirements for Cosmetic Regulations in Saudi Arabia
Precise and accurate labelling is crucial for consumer safety and informed choices. The SFDA mandates that all cosmetic products bear labels in Arabic, providing essential information such as product name, ingredients, instructions for use, and contact details of the manufacturer or distributor. Compliance with these labelling requirements is essential for market access and consumer trust.
When submitting cosmetic product notifications, a clear image (one or more) of the product from all sides that shows its information and substitutions in a visible and readable way is required. The image shall include the internal and external product label and its internal brochure, if any. The images can be presented in one of the following forms: PNG, JPG, TIFF, or PDF.
The cosmetic product label shall confirm with the Cosmetic Products Legislation and the Standard of Safety Requirements for Cosmetic Products and personal care No. GSO1943/20016.
The product label must contain its barcode and shall be entered into the cosmetic notification system, taking into account the product’s size and colour.
Post-Market Surveillance
To ensure ongoing consumer safety, the SFDA conducts post-market surveillance to monitor the safety and quality of cosmetic products already in circulation.
This involves regular inspections, product sampling, and analysis to identify potential risks or violations. Manufacturers and distributors must cooperate fully with the SFDA during these surveillance activities to maintain compliance.
Conclusion
Saudi Arabia’s cosmetics industry thrives, driven by a dynamic consumer base seeking high-quality, safe, and culturally appropriate products. The regulatory framework established by the SFDA plays a pivotal role in maintaining the integrity of the market and ensuring that cosmetics meet the highest standards.
As the industry continues to evolve, staying abreast of the regulatory landscape is imperative for businesses seeking success in Saudi Arabia’s beauty sector.
Beauty truly knows no borders, and by understanding and adhering to the regulations, companies can contribute to the flourishing beauty industry in the Kingdom while prioritizing consumer well-being.
Interaction with other medical products and forms of interaction
Pregnancy and lactation If are pregnant, think may be pregnant or are planning to have a baby or are breastfeeding, ask doctor before taking the vaccine.
Effects on the ability to drive and use machines
Undesirable effects
Pharmacological Properties
Pharmacodynamic properties
Pharmacokinetic properties
Preclinical safety data
Pharmaceutical Particulars
List of excipients
Incompatibilities
Shelf life
Special precautions for storage
Nature and contents of container
Special precautions for disposal and other handling
BioSimilaritystudies(In Biosimilar)
Marketing Authorisation Holder
Marketing Authorisation Number(s)
Date Of First Authorisation/Renewal ofthe Authorisation
Date Of Revision ofthe Text
Thailand, governed by the Drug Act B.E.2510. The key points are as follows
1. Legal Basis and Scope
Article 79 of the Drug Act mandates that no drug can be manufactured or imported into Thailand without obtaining marketing authorization from the Thai Food and Drug Administration (TFDA).
Articles 80, 81, and 82 of the Drug Act specify the application dossier requirements, including quality, non-clinical, and clinical information following the ASEAN Common Technical Documents (ACTD) or ICHCTD standards.
2. Application Particulars
The marketing authorization application must include details such as trade name, formulation, pack size, analytical method, label, product leaflet, and other documents as outlined in the Ministerial Regulation.
3. Variation Approval
Any variation to a marketing authorization requires prior approval from TFDA.
4. Procedural Mechanism
The procedures for marketing authorization applications, variation requests, and the issuance of credential certificates align with Ministerial Regulation No.18 (B.E.2525) under the Drug Act B.E. 2510.
5. Role of Drug Committee
Article 10 (1) of the Drug Act assigns the Drug Committee the duty to provide advice or justification for permitting the manufacturing, sale, or import of drugs into Thailand, including their marketing authorization.
6. Focus on Vaccines
The guideline specifically addresses procedural aspects related to the marketing authorization of vaccines.
A vaccine is defined as an immunogen intended to stimulate the immune system for disease prevention, amelioration, or therapy. It may take various forms, including live attenuated preparations, inactivated whole organisms, recombinant DNA-derived immunogens, and more.
Administrative and Scientific
Administrative and scientific advice is available at various stages of the drug development process. It can be sought during initial development, before submitting a marketing authorization application, or in the post-opinion phase.
4 Procedure for Submission of the Application for A TFDA Marketing Authorization Decision
Before submitting an application for marketing authorization to the TFDA, applicants can request a pre-submission meeting. This meeting allows discussions on procedural, regulatory, or legal issues related to the proposed submission.
To request such a meeting, applicants need to use the “Pre-Submission Meeting Request Form.”
1. Before Submission
At least six months prior to submission of an application for Marketing Authorization decision, applicants should notify the TFDA of their intention to submit an application and give a realistic estimate of the month of submission.
In that notification applicants should include:
a draft SPC;
an indication on the number of strengths / pharmaceutical forms / pack sizes (if already known);
if applicable, their intention to present any existing Vaccine Antigen Master File (VAMF) or Plasma Master File (PMF) Certificates
the details of proposed manufacturing sites for the finished product and active substances
a specification of any regulatory issues or difficulties already identified which may require clarification or detailed consideration
2. Submission of the Application
The applicant shall submit the application at the One Stop Service Center (OSSC), TFDA a temporary permit number is issued to the applicant, and verification is completed within 30 calendar days.
3. Dossier to be Submitted
Supporting documents must be submitted in electronic Common Technical Document (eCTD) or other electronic submission platforms as appropriate. If the applicant wishes to use the VAMF or PMF certificate included in the application, the applicant must provide a valid certificate of conformity with the VAMF or PMF in accordance with the EMEA Directive 2003/63/EC Part III and the accompanying assessment report must be provided.
Use relevant VAMF and PMR data. In the case of vaccines containing or consisting of genetically modified organisms (GMOs), the request must be accompanied by documentation from the competent authorities for the intentional release of GMOs into the environment.
In addition, the applicant must provide evidence of the establishment of the applicant and future marketing license holder in the Kingdom of Thailand, as well as documents showing the ability and commitment to perform all the responsibilities required of the marketing license holder, in particular:
• a document identifying the person for pharmacovigilance who will be the contact person for any specific pharmacovigilance issues, together with a curriculum vitae and contact details
• a document identifying the contact person responsible for any quality issues including its contact details
4. Validation by the TFDA
During verification, the TFDA PTL may determine the need for actions related to items such as GMP testing, samples for analysis, GCP testing, communication with environmental authorities, and data integrity.
If TFDA needs additional data, information, or clarification to complete document approval, it will contact the applicant and request to provide such data, information, or clarification within a specified deadline.
4.1. Positive outcome of the validation
If the result is positive, the TFDA has 60 days the applicant must notify in writing that the verification has been completed. Ask external TFDA experts to send 4-7 copies of the document to TFDA PTL.
Applicants must also enter additional data. Information provided during the verification of supporting documents. The evaluation plan adopted by TFDA will be attached to the letter. Confirm positive validation results. Individual arrangements must create a PTL for the copies have.
4.2. Negative outcome of the validation
In the event of a negative validation outcome, where the requested data, information, or clarifications are not provided, the applicant will receive written notification.
If the application cannot undergo validation, the applicant will be given the option to either retrieve the dossier or authorize its destruction by the TFDA. Initiating a new procedure becomes necessary if the applicant plans to submit a complete dossier to the TFDA in the future.
4.3. Management of applications
Data Entry into Tracking System: Once validated, product details are recorded in the TFDA tracking system using a numbering system that provides clear identification throughout the product’s life cycle, including applications for marketing authorization, variations, and transfers.
Identification of Vaccine Applications: Applications for TFDA marketing authorization of vaccines can be identified by the invented name or, if available, the international non-proprietary name (INN)/common name of the active substance(s) combined with the applicant’s name.
For administrative purposes, each application is assigned a core number, consisting of four sections: 1A9000X/year, 2A9000X/year, 1B9000X/year, 2B9000X/year, 1C9000X/year, 2C9000X/year. Here, 1 represents one active substance, 2 represents more than one active substance, A stands for manufacture, B for repack, and C for import.
4.4. Need for samples and sample analysis
No Initial Sample Requirement: Applicants are not required to submit samples of the proposed vaccine at the time of application submission.
TFDA Request for Sample Testing: TFDA encourages applicants to submit vaccine samples promptly for testing at the Division of Biological, Department of Medical Sciences. This early submission helps ensure timely testing.
Test Protocol Specification: The National Control Laboratory (NCL) at the Institute of Biological, Department of Medical Sciences, in collaboration with TFDA, will outline a test protocol.
This protocol includes details such as sample types, sample quantity, batch numbers, specified tests, and the methods and specifications to be used.
Reporting Test Results: Upon completion, the test results are reported to the TFDA Product Team Leader (PTL). These results play a crucial role in the finalization of the TFDA Assessment Report.
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 convergence of minds, ideas, and innovations that will shape the future of healthcare on a global scale.
Discover Insights on Crucial Topics
Unlocking 2024: Navigate the Current UK Landscape
UAE: A Prime Market for Medical Device Expansion
Why Saudi is an Attractive Market in 2024
Navigating the Landscape of EU Medical Device Regulation (MDR)
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 comprehensive analysis explores the key points of these amendments, focusing on the intricate timeline considerations.
Paragraph 3 Amendments
Paragraph 3 has undergone crucial revisions, introducing new provisions (3a to 3g) that outline conditions and timelines for the placement of medical devices on the market or into service.
Let’s delve into the details of these Regulation (EU) 2017/746 amendments:
3a. Derogation and Conditions
By derogation from Article 5, devices falling under paragraphs 3b and 3c may be placed on the market or put into service, subject to the fulfilment of conditions specified in paragraph 3d.
3b. Placing Devices with Certificates
Devices with certificates issued under Directive 90/385/EEC or Directive 93/42/EEC, valid by virtue of paragraph 2, can be placed on the market until specific dates:
– Until 31 December 2027 for class III devices and class IIb implantable devices (excluding specific items).
– Until 31 December 2028 for class IIb devices (excluding those covered by the previous point), class IIa devices, and class I devices in sterile condition or with a measuring function.
3c. Conformity Assessment Procedure
Devices with conformity assessment procedures under Directive 93/42/EEC, not involving a notified body, may be placed on the market or put into service until 31 December 2028, provided certain conditions are met.
3d. Conditions for Placement
Devices can be placed on the market until the specified dates (3b and 3c) if the following conditions are met by 26 May 2024:
– Continued compliance with relevant directives.
– No significant changes in design and intended purpose.
– No unacceptable risk to health or safety.
– Implementation of a quality management system by the manufacturer.
– Lodgement of a formal application for conformity assessment by 26 May 2024 and a written agreement signed with a notified body by 26 September 2024.
3e. Application of MDR Requirements
In derogation from paragraph 3a, devices in paragraphs 3b and 3c are subject to MDR requirements for post-market surveillance, market surveillance, vigilance, and registration of economic operators and devices.
3f. Responsibilities of Notified Bodies
The notified body issuing the certificate in paragraph 3b remains responsible for surveillance unless agreed otherwise. A transition of surveillance responsibilities is outlined in agreements between manufacturers and notified bodies.
3g. Derogation for Class III Custom-made Implantable Devices
Class III custom-made implantable devices can be placed on the market until 26 May 2026 without a certificate, provided a formal application is lodged by 26 May 2024, and a written agreement with a notified body is signed by 26 September 2024.
Paragraph 4 Replacement
Paragraph 4 stipulates that device lawfully placed on the market before 26 May 2021, and those placed afterward under paragraphs 3a, 3b, 3c, and 3g, may continue to be made available or put into service.
Article 122 Amendments
Article 122 outlines amendments related to the repeal of Directives 90/385/EEC and 93/42/EEC, effective from 26 May 2021. Noteworthy points include the continuation of Directives’ application for devices in specific paragraphs of Article 120(3a) to (3f) and (4).
Article 123 Amendments
In Article 123(3), point (d), the amendment includes a reference to Article 120(3e), further emphasizing the continued application of certain requirements from the repealed Directives.
Regulation (EU) 2017/746 Amendments
The amendments to Regulation (EU) 2017/746, also known as the In Vitro Diagnostic Devices Regulation (IVDR), focus on Articles 110 and 112.
Article 110 Amendment
Devices lawfully placed on the market under Directive 98/79/EC before 26 May 2022, and those placed afterward under paragraph 3 of this Article, may continue to be made available or put into service.
Article 112 Amendment
For devices referred to in Article 110(3) and (4) of the IVDR, Directive 98/79/EC shall continue to apply to the extent necessary for the application of those paragraphs.
Conclusion
The recent amendments to MDR and IVDR introduce a complex framework of conditions and timelines for the placement of medical devices on the market. Stakeholders, including manufacturers and notified bodies, must carefully navigate these provisions to ensure compliance and a smooth transition to the new regulatory landscape.
