SFDA Medical Device Registration in South Africa
SFDA has issued various guidelines for the regulations of medical devices. if you want to place the product in Saudi Arabia you need approval from MDMA i.e. Medical Device Market Authorization.
This is an electronic system and the system aims to authorize medical devices once they comply with MDIR, which means Medical Device Interim Regulations.
SFDA Medical Device Registration and Regulations
KSA (Kingdom of Saudi Arabia) has been rated among the top 20 economically competitive countries in the world. SFDA is a regulatory authority for medical devices and IVDs sold and distributed in Saudi Arabia. MDMA approval is needed to place your devices in the Saudi Arabian market. SFDA reviews MDMA applications and prepares your submission carefully. Saudi Arabia updated their medical device regulations between 2019 and 2022, which affected device classification and changed the concept and content of the MDMA (high-risk application). Due to the changes and updated guidance, previously approved devices, IVDs, and medical supplies must comply with new regulations. As a medical device regulatory consultant, we always keep an eye on changes in regulations and current updates so that we can serve our clients better.
SFDA Medical Device Registration and Approval Process:
Following Are the Steps to Register Your Medical Devices:
1. Medical Device Classification:
SFDA device classification | Risk class | MDR rule |
A | low | I |
A-sterile | Low-medium | Is |
A-Measuring functions | Low –medium | Im |
A-Reusable surgical instrument | Low-Medium | Ir |
B | Low-Medium | IIa |
C | Medium -High | IIb |
D | High | III |
The SFDA is also adopting the European medical device regulation IVDR:
SFDA medical devices class | Risk class | Classification rule |
A | Low | A |
B | Moderate | B |
C | Moderate-High | C |
D | High | D |
- Appointment of AR If Needed
Authorized representatives (AR) need to be registered and approved by SFDA. The legal manufacturers have two options one is to assign their local distributor and the second one is to assign a consulting office that can provide more power and freedom to the legal manufacturer in the market. Low-risk medical devices don’t need AR.
- Apply to MDMA and Medical device registration:
Medical device manufacturers need to register their devices with SFDA and obtain a certificate from MDMA (Medical Device Market Authorization) as per the MDIR (Medical Device Interim Regulations) in Saudi Arabia. MDMA is needed for high-risk devices whereas low-risk devices (non-sterile, non-measuring) don’t require prolonged MDMA.
How We Help You With Regulatory Service:
If you are a new manufacturer or already active commercially, our Team of Operon Strategists ensures compliance and efficient regulatory support through
- Providing Assistance in regulatory processes
- Providing Guidance for QMS establishments
- We help our clients in design and development & GAP analysis for products and companies.
- We create technical files for submission.
- Provide proper response and submission to SFDA inquiries
- Follow up till regulatory approval.
Feel free to ask any query related to this or to avail our services contact us.