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SFDA stops the listing procedure of low risk medical devices

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The Author

Regulatory Editor

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.

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The Author

Regulatory Editor

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