Saudi Arabia is evolving as growing market for healthcare sector, there are huge opportunities which are attracting to medical device manufacturers. SFDA I.e The Saudi Food & Drugs Authority is a government agency who regulates drugs and medical devices in Saudi Arabia. SFDA oversees safety, security and effectiveness of medical devices, it also controls and supervises manufacturing facilities and also looks after the importation and registration of medical devices. SFDA updated medical device regulation in Saudi Arabia. 

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.  

What is 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. 

According to MDIR the companies who already having approval in  Austarlia,Canada, Europe, Japan or USA, (GHTF countries means Global Harmonization Task Force countries) reference market and registration in one of these markets   is mandatory for the registration in Saudi Arabia.   

However, SFDA cancelled the GHTF route by the end of 2021. From January 2022 MDMA applications must undergo technical file assessment (TFA) procedure. So, the MDMA requirement evolved to be rigorous with many more conditions. The low-risk devices need to re-register through MDMA route which needs TFA application. The medical device manufacturers who are not based in KSA need to appoint an Authorized representative (AR). They will act as liaison between you and SFDA, as per the MDIR.  The Authorized Representative should obtain an AR license which is renewable on an annual basis to legally represent you in KSA.

What is SFDA Medical Device Registration and Approval Process: 

Following are the steps to register your medical devices; 

  1. Medical device classification. 
  2. Appointment of AR if needed 
  3. Apply to MDMA 

1.Medical Device Classification: 

Medical devices are classified As Clas A, Class B, Class C, and Class D as per the risk associated with them. The classification of medical devices is necessary for the registration procedure. SFDA classifies the medical devices the way EU MDR does. The classification of your medical devices or IVDs will be based on classification done from reference market. 

 

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. Authorized Representative (AR):

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. 

  • Low risk device registration: 

As per SFDA the manufacturer /companies of low-risk medical devices need to register their product with MDNR (Medical Device National Registry). This is a listing procedure applicable for Class I, but non-sterile and non-measuring products.  It has been observed that during this process SFDA raises queries or sends inquiries back, and to resolve them properly companies hire experienced medical device regulatory  consultants . There are two routes of registration  

  1. Abridged route requirement 
  1. Direct Route requirement. 
Timeline for SFDA medical device registration process: 

 Generally, it takes 2 weeks, but also depends on the amount of SFDA inquiries and the company’s response.  

  • High risk medical devices registration (MDMA): 

For the registration of High-risk medical devices companies need to appoint AR (Authorized Representative). The AR agreement and SFDA AR license is mandatory before application submission. As we mentioned above From January 2022, TFA (Technical File Assessment) procedure is accepted for MDMA application.  for the creation of technical file for the documents, you need guidance from consultants. A few points which are required in the technical file: 

  • Device description/ intended use 
  • Design and manufacturing information 
  • Risk management file  
  • PMS 
  • PSUR 

Besides these documents SFDA may ask for more details and documents during the application process. 

Timeline for SFDA medical device registration process: 

For the fresh application it may take 12 weeks, and for renewable /update application it will take approx 8 weeks from submission to SFDA. 

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 India, Saudi Arabia, USA, Costa Rica, Oman, South Africa & United Kingdom.  Feel free to ask any query related to this or to avail our services Contact us.