Medical Devices 101 | Your Questions | May 2023
Medical devices face a unique regulatory landscape that has been increasingly complicated by several factors in recent years.
The demand for more sustainable technology is being driven by both consumer demand and legislators, leading to regulatory implications. Global events such as Brexit and COVID-19 have also created unprecedented challenges.
As devices become increasingly integrated with artificial intelligence and an internet connection, new cybersecurity and data protection legislation is racing to keep up.
And on top of all this, the new regulatory framework for IVDR and proposed amendments for the registration, and inspection of medical devices under MDR means staying ahead is more critical than ever.
In our new series, we gather some of the most interesting recent inquiries from Compliance & Risks customers regarding the medical device regulatory updates globally:
Question 1: What are the compliance requirements to import ophthalmic lenses into Saudi Arabia?
Catherine Burke, QA Manager answers:
Manufacturers must register with the Saudi Food and Drug Authority (SFDA) and comply with the Medical Device Interim Regulation in order to place a medical device on the market in Saudi Arabia. As per Article Fifteen of the executive regulations for the control of medical devices and products issued by the decision of the Board of Directors of the Food and Drug General Authority No. (1-8-1429), the Medical Device Interim Regulation, and the Guidance document; License to Import and Distribute Optical Medical Devices, 2021, importers and distributors of optical devices and products must obtain a license for the facility, its branches, and warehouses from Commission.
In C2P, the supporting document; License to Import and Distribute Optical Medical Devices 2021, covers the process for obtaining the required license. The mechanism for obtaining a new license to import and distribute optical devices and products is outlined in Chapter II and involves opening an account and registering in the unified electronic system (Ghad). Chapter 4 covers the requirements and documents for applicants. Specifically, the applicant must submit the following:
- An account number for the establishment of the investor and granted to him by the Authority.
- A list of the types of medical devices and products to be supplied to the Kingdom, and detailed information about the addresses of the manufacturers of these devices.
- The undertaking that the facility has the documents that indicate its commitment to its responsibilities contained in Article Sixteen of the Medical Devices and Products Control Regulations.
Notify the Authority of any change in the information submitted within ten days of the change. Chapter 5 covers the mechanism for obtaining a license through SFDA Electronic System:
- Create an account in the Unified Electronic System (GHAD) and get an account number for the establishment.
- In the Unified Electronic System of SFDA (GHAD), select (Medical Optical License)
- Fill out the application form and attach the required documentation.
- Pay the fee for the service.
Chapter 6 covers license terms and fees and chapter 9 covers common questions.
Saudi Arabia Requirements for Medical Devices Marketing Authorization, Document MDS – REQ 1, Version 6.0, December 2021, contains detailed requirements for the technical documentation and clarifies the requirements for obtaining medical devices marketing authorization (MDMA). Medical devices may be made available in return for payment or free of charge, with a view to distribution and/or use within the KSA only if it is registered at SFDA and obtaining medical devices marketing authorization (MDMA). Medical devices shall comply with the “Essential Principles of Safety and Performance” specified in Annex (1) and Annex (2) of Document MDS – REQ 1.
As per Document MDS – REQ 1, Medical device manufactures shall: Prepare, hold and update the Medical Device Technical Documentation that confirms to “Essential Principles of Safety and Performance” specified in Annex (3) and Annex (4) and establish, document and maintain an effective quality management system (QMS) according to the international ISO standard (ISO 13485:2016) or any identical adopted standard for the same issue/version.
With regards to submitting to the SFDA, an application shall be submitted by a local manufacturer, an overseas manufacturer, or the AR of the overseas manufacturer if an overseas manufacturer wishes, after they obtain the following:
- Local Manufactures: License of medical devices manufacture through the “GHAD System – Licensing Services”
- Authorized Representative: License of authorized representative through the “GHAD System – Licensing Services”
- The Applicant shall submit the “Application Form for Medical Devices Marketing authorization” electronically via “GHAD System -Marketing Authorization Services” and provide the required documents specified in the application form.
Regarding low-risk medical devices (except IVDs, sterile, having measuring function, reusable surgical instruments, and novel), the following shall be submitted in accordance to “Technical Documentation” in Annex (3):
- Device Description and Specification
- Information to be Provided by The Manufacturer
- Essential Principles Checklist
- Evidence of Compliance with the Applicable Essential Principles
- Risk Management File
- Post-Market Surveillance Plan and Report
SFDA has the right to request all “Technical Documentation” if necessary, even after obtaining the MDMA, and they shall be provided within (10) days of its request.
The Applicant shall pay fees specified in Annex (12). Medical devices may be bundled/grouped within one MDMA application based on the criteria mentioned in Annex (15). Once satisfied, SFDA will issue MDMA including the information specified in Annex (13)
Post submitting, the SFDA shall be informed, via the electronic system, within (10) days of the occurrence of any significant change to the relevant information or (30) non-significant changes. The MDMA certificate shall be renewed before its expiration date, and the updated documents, if necessary, shall be submitted through the electronic system, and a renewal request can be submitted 90 days before its expiry date.
In C2P, please refer to the following important documents;
Saudi Arabia: Medical Devices Interim Regulation, 1-8-1429 2008
Saudi Arabia: License to Import and Distribute Optical Medical Devices Guide, 2021
Saudi Arabia: Requirements for Medical Devices Marketing Authorization, Document MDS – REQ 1, Version 6.0, December 2021, which contains detailed requirements for the technical documentation and clarifies the requirements for obtaining medical devices marketing authorization (MDMA).
Saudi Arabia: Medical Devices and Supplies Regulation, Royal Decree No. M/54, 2021
Question 2: Looking for the application to WEEE here, if there is any! Not seeing anything in English that would include Medical Devices. South Korea: Promotion of Saving and Recycling Resources Enforcement Ordinance, Presidential Decree No. 13915, 1993 – Proposed Amendment – (on recycling charges) Draft Decree, May 2023
Catherine Burke, QA Manager answers:
Our SME for South Korea has looked into this and responded as follows:
Recycling charges referenced in this draft amendment are imposed when “producers obligated to recycle” fail to comply with their recycling obligations. Applicable products are listed in Article 18 of the Enforcement Decree of the Act on the Promotion of Saving and Recycling of Resources which includes batteries, fluorescent lamps and packaging of electrical appliances, etc.
Medical device products themselves are not included in this list of applicable products, but synthetic resin packaging materials used for certain medical devices may be applicable.
Question 3: Hi! looking for more info if medical devices are included in Singapore: Resource Sustainability (Prescribed Regulated Products) Regulations, GN No. S 900/2019 – Amendment – (on First Schedule on licensed scheme thresholds) Regulations, GN No. S 293/2023
Denise McDermott, Senior Regulatory Compliance Specialist answers:
In Singapore: Resource Sustainability (Prescribed Regulated Products) Regulations, GN No. S 900/2019 – Amendment – (on First Schedule on licensed scheme thresholds) Regulations, GN No. S 293/2023, regulated products include the following;
“Every product specified in the first column of the First Schedule and in the Second Schedule is a regulated product for the purposes of Part 3 of the Act, if the product is not a component of, or the product itself is not:
- a product designed for military use; or
- a medical device mentioned in the First Schedule to the Health Products Act (Cap. 122D), except an electric mobility scooter.”
Stay Compliant With Global Medical Device Regulations:
Catch up on our latest medical device updates with your coffee here:
- IVD Regulations In The EU
- IVDR Regulatory Compliance: What are your IVDR and product blindspots?
- IVDR Compliance: What You Need To Know
- Regulatory Developments in Medical Devices: A Review of Recent Legislation
Have you got a Medical Device related query?
Clients use AOE to ask about the latest proposed, enacted, and amended regulations and mandatory standards applicable to their products and geographies of interest.
When AOE questions can be answered in 30 minutes or less, Compliance & Risks’ subject matter experts answer them at no charge!
To learn more about C2P and how Compliance & Risks SMEs can help you with your questions, contact us today.
Meet our Experts
Denise McDermott, Senior Compliance Specialist, Compliance & Risks
Prior to joining Compliance & Risks, Denise worked in the medical device industry for 13 years across a number of areas including regulatory affairs, post-market surveillance, customer complaints, quality, and technical support.
She has experience in several areas including IVDR, CE marking, labeling, legal documentation, customer and quality technical communications and regulatory risk assessments.
Catherine Burke, Quality Manager, Compliance Specialist, Compliance & Risks
Catherine Quality Assurance Manager within Compliance and Risks. Her role involves responsibility for the quality, integrity and accuracy of data.
She is also responsible for the coordination of the Global Regulatory Compliance Team within Compliance and Risks.