SFDA Cancels the MDNR Procedure

The Author

Regulatory Editor

Published and maintained by PharmaKnowl team.

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.

Read More:

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

The Author

Regulatory Editor

Published and maintained by PharmaKnowl team.