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.

SFDA Medical Device Registration & Regulations:

KSA (kingdom of Saudi Arabia) has been rated in the top 20 economically competitive countries in the world. SFDA is regulatory authority for medical devices and IVDs sold and distributed in Saudi Arabia. MDMA approval is needed to place your devices in Saudi Arabia market. SFDA reviews MDMA applications to prepare your submission carefully. Saudi Arabia updated their medical device regulations between 2019 to 2022, which affected device classification and changed concept and content of the MDMA (high risk application). Due to the changes and updated guidance previously approved devices, IVDs, 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 better to our clients.

SFDA approval

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 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.

  1. 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 Services:

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 with 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 contact us.

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Operon Strategist Provides FDA 510k Consultancy Services in Worldwide

FDA 510k Registration for Medical Devices in the US

FDA 510k Registration for Medical Devices in Saudi Arabia

FDA 510k Registration for Medical Devices in Egypt

FDA 510k Registration for Medical Devices in the UK

FDA 510k Registration for Medical Devices in the Germany

 

FDA 510k Registration for Medical Devices in Oman

FDA 510k Registration for Medical Devices in South Africa

FDA 510kCDSCO Registration for Medical Devices in India

FDA 510kCDSCO Registration for Medical Devices in Iran

FDA 510kCDSCO Registration for Medical Devices in Netherlands