SFDA Sunsets the MDNR Procedure for Low-Risk Medical Devices

The SFDA has recently closed the Medical Device National Registry (MDNR) application process, which was used for low-risk medical devices. They now require all medical devices to go through the Medical Device Marketing Authorization procedure (MDMA Registration), which requires a whole technical file assessment TFA, even for the low-risk medical devices (non-measuring and non-sterile). They officially defined the end date of the MDNR listing procedure, which was simple, fast, and with low SFDA fees. We summarize the announcement in the following points:

• New and renewal requests on the current procedure will end by 27/9/2022.
• Any upcoming approvals under the current procedure will only receive a one-year validity certificate.  
• Currently approved low-risk devices (non-sterile, non-measuring) will be valid till their expiry date.
• From 27/9/2022, such devices must fulfil MDMA requirements.
• A Saudi Authorized representative is required for all products (even low-risk).

In summary, companies must be ready to switch to the new MDMA procedure for all types of medical devices.

Read More:

• SFDA Registration
• SFDA Classification
• ISO 13485 for Medical Devices