SFDA stops the listing procedure of low risk medical devices

The SFDA has just announced a new update in the registration process of medical devices . It states that the full technical file assessment TFA will become mandatory on the low-risk medical devices (non-measuring and non-sterile). This time, they officially defined the death date of the current listing process which is 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.
  • Saudi Authorized representative is a required for all products (low and high-risk).

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

Our website uses cookies and asks for your insensitive personal data to enhance your browsing experience.