SFDA Medical Device Registration
SFDA Medical Device Registration in Saudi Arabia for Oman Manufacturers
Saudi Arabia is one of the fastest-growing healthcare markets in the Middle East, offering huge opportunities for medical device manufacturers. To enter this market, obtaining SFDA medical device registration is mandatory. The Saudi Food and Drug Authority (SFDA) regulates devices through the Medical Device Marketing Authorization (MDMA) system, ensuring that only safe, effective, and high-quality devices are available in the Kingdom of Saudi Arabia (KSA). At Operon Strategist, we support Oman-based and global manufacturers in completing the SFDA registration process with ease, ensuring faster approvals, regulatory compliance, and seamless market access.
Why SFDA Medical Device Registration is Important?
- Mandatory for Selling in Saudi Arabia – No medical device can be marketed in KSA without SFDA approval.
- Ensures Regulatory Compliance – Devices must meet safety, performance, and quality standards.
- Builds Trust & Credibility – Healthcare providers and patients rely on SFDA-approved devices.
- Faster Market Entry – Early approval helps manufacturers tap into Saudi Arabia’s expanding healthcare sector.
Also read: Medical Device Registration in Oman – Step-by-Step Guide
SFDA Registration Process for Medical Devices in Saudi Arabia
Determine Device Classification – Class A, B, C, or D, based on risk level.
Appoint a Local Authorized Representative (LAR) – Essential for foreign and Oman-based companies to operate in Saudi Arabia.
Prepare Technical Documentation – Including device description, intended use, safety, performance, and risk analysis reports.
Quality Management System Compliance – Manufacturers must comply with ISO 13485 or an equivalent standard.
Submit Application via MDMA System – The official SFDA online platform for medical device approvals.
Review & Approval by SFDA – Evaluation of safety, effectiveness, and compliance with regulatory standards.
Post-Market Surveillance & Renewals – Continuous monitoring, reporting of adverse events, and timely license renewals.
Related service: ISO 13485 Certification in Oman
How to Register With SFDA for Medical Device Registration and Approval?
Following are the Steps to register your medical devices:
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 Operon Strategist Helps You
End-to-End SFDA Registration Support – From device classification to final approval.
Technical File & Quality Documentation Preparation – Ensuring your submission is complete and error-free.
Assistance in Appointing Authorized Representatives (LAR) – Helping you establish a compliant presence in Saudi Arabia.
ISO 13485 Compliance & Audit Guidance – Aligning your QMS with international standards.
Faster Approvals with Expert Strategy – Minimized delays through our proven regulatory approach.
Explore more: Turnkey Medical Device Project Consultants in Oman
Get in touch with our experts today and fast-track your SFDA approval!
Why Choose Operon Strategist?
Over a decade of expertise in medical device regulatory consulting.
Strong experience with Middle East markets including Oman, Saudi Arabia, and the UAE.
Proven record of helping manufacturers achieve SFDA, ISO, and CE Marking approvals.
End-to-end support from facility setup to product registration.
You may also like: CE Marking for Medical Devices in Oman
FAQs
What is SFDA medical device registration?
SFDA medical device registration is the regulatory process managed by the Saudi Food and Drug Authority (SFDA) to ensure that medical devices, IVDs, and medical supplies meet safety and performance standards before being placed in the Saudi Arabian market. It involves obtaining MDMA (Medical Device Market Authorization) under the Medical Device Interim Regulations (MDIR).
Why is MDMA approval important?
MDMA approval is mandatory for placing medium and high-risk medical devices in the Saudi market. It certifies that the device complies with Saudi Arabia’s safety, quality, and regulatory requirements under SFDA rules.
Who needs to register with SFDA?
All manufacturers, importers, or legal representatives who wish to place medical devices or IVDs in Saudi Arabia need SFDA approval. For low-risk Class A devices, limited requirements may apply.
Is an Authorized Representative (AR) required for SFDA registration?
Yes. Non-Saudi manufacturers must appoint a local Authorized Representative (AR) registered with SFDA. AR can be a local distributor or a consulting office, depending on the desired level of control and support.
Is QMS compliance required for SFDA registration?
Yes. SFDA requires compliance with a recognized Quality Management System (QMS) such as ISO 13485:2016 for most medium and high-risk medical devices.