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.
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Published by regulatory affairs team in PharmaKnowl, Riyadh office.
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