Medical Device SFDA Registration - Overview

The SFDA has released several guidelines governing medical device regulations. To place a product in Saudi Arabia, approval from the MDMA (Medical Device Market Authorization) is required. This electronic system aims to authorize medical devices upon compliance with the MDIR (Medical Device Interim Regulations).

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Medical Devices SFDA Registration Process

Here’s a concise overview of the medical device registration and approval process:

  1. Appoint a Saudi authorized representative (AR): Legal manufacturers can benefit from advanced regulatory support by appointing a knowledgeable AR, who can assist with SFDA regulations and facilitate the transfer of MDMA approvals if needed.
  2. Prepare the technical file for MDMA submission: Conduct a thorough gap analysis to ensure compliance with SFDA requirements. Identifying gaps is crucial for addressing research, reports, or post-approval commitments like PMCF in Saudi Arabia, as rejected applications incur significant SFDA expenses and delays.
  3. MDMA Submission: Submitting a registration file that is prepared by a specialized regulatory professional is crucial, as the SFDA may reject files that do not meet their standards. Properly prepared applications can expect technical inquiries similar to those from notified bodies, with limited waivers for response and a specified timeframe.
  4. MDMA Approval: Once approved by the SFDA, the license owner, typically the legal manufacturer, can ship the goods to Saudi Arabia with all necessary SFDA requirements for 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

  1. 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.

  1. 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, 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. 

We also provide medical device consultation for the USA, Costa Rica, the UK, Oman, South Africa, Saudi Arabia, & Egypt. Contact us now for a free consultation.