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.