SFDA Medical Device Registration
Saudi Arabia Medical Device Regulations - Overview
SFDA has issued various guidelines for the regulations of medical devices. if you want to place product in Saudi Arabia you need approval from MDMA I.e Medical Device Market Authorization.
This is an electronic system and the aim of the system is to authorize medical devices once they comply with MDIR, which means Medical Device Interim Regulations.
Looking for Consultation Services for Medical Device Registration in Saudi Arabia
Let’s have a talk about your project
Medical Devices Registration Process in Saudi Arabia
We can summarize the medical device registration and approval process in the following few steps:
- Appoint a Saudi authorized representative (AR)
Through a knowledgeable AR, legal manufacturers can have advanced regulatory support with the ever-changing SFDA regulations. Even if there was an appointed AR before, manufacturers can transfer to a new AR and transfer all old MDMA approvals. Contact us for more details. - Prepare the technical file for MDMA submission
Companies must do a thorough gap analysis on the available file against the SFDA requirements in order to be ready for MDMA submission. Identifying the gaps is essential for determining the required research, reports, or post-approval commitments, such as PMCF in Saudi Arabia. Rejecting an application costs time and faces substantial SFDA expenses. - MDMA Submission
The SFDA will not accept a registration file that has clearly been submitted by a non-specialized regulatory professional. The SFDA’s reply will not specify the gaps and what needs to be done; instead, the applicant will be asked to resubmit according to the applicable rules. If it was properly prepared, however, the applicant should expect technical inquiries similar to those received from notified bodies. The applicants will be given a limited number of waivers from responding to questions as well as a time frame. - MDMA Approval
Once granted by SFDA, the owner of the license, which is always the legal manufacturer, can ship the goods to Saudi with all necessary SFDA requirements for shipment clearance at Saudi ports.
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 second one is to assign a consulting office who can provide more power and freedom to the legal manufacturer in market. Low risk medical devices don’t need AR.
- Apply to MDMA and Medical device registration:
Medical device manufacturers need to register their device with SFDA and obtain a certificate from MDMA (Medical Device Market Authorization) as per the MDIR (Medical Device Interim Regulations) 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, we Team of Operon Strategist ensure 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.
FAQs
Is a CE Mark Required for Medical Devices in Saudi Arabia?
In Saudi Arabia, CE certification is required for high-risk medical devices that could pose significant safety or health risks to users. These devices must be certified by a notified body to ensure compliance with stringent safety and performance standards.
How Long Does It Take to Register a Medical Device in Saudi Arabia?
The Saudi Food and Drug Authority (SFDA) generally takes 30 to 60 days to review initial medical device registration submissions. However, the timeline may vary depending on the completeness of the documentation and the complexity of the device.
What Are the SFDA Labeling Requirements?
The SFDA labeling requirements mandate that medical device labels include a Unique Device Identifier (UDI) code, expiration date, control or batch number, storage and handling instructions, indications for use, and any other relevant information needed for safe and effective device use. These standards ensure traceability, compliance, and user safety.
Do All Devices Require MDMA Approval?
Yes, all medical devices and in vitro diagnostics (IVDs) that fall under the definition outlined in Article 1 of the Medical Devices Law must obtain MDMA approval.