According to Circular No. MDS-CIR-001-V1/220324 published by SFDA (Saudi Food and Drug Authority, the Saudi Arabian Regulatory Authority for Medical Devices and IVDs), the deadline for submitting new or renewal applications for Class A (low-risk, non-measurement and non-sterile) Medical Devices under the MDNR was 27 September 2022.
It is therefore mandatory that all such Medical Devices have a valid marketing authorisation in Saudi Arabia, otherwise they must be withdrawn from the market immediately.
SFDA has also established the process of receiving applications for marketing authorisations for low-risk, non-sterile, non-measurement Medical Devices in the following ways:
- Applications registered before 27/09/2022 will be valid until their expiry date;
- New applications accepted until 27/9/2022 will be valid for one year from the date of acceptance. In addition, while the registration is valid, compliance with MDMA requirements must be ensured and an Authorised Representative must be appointed for foreign manufacturers.
- As of 27/09/2022 for non-sterile, non-measuring low-risk Medical Devices, MDMA can be applied for through the Ghad System (Unified Electronic System).
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Sources: https://www.sfda.gov.sa/sites/default/files/2022-12/MD7122022A.pdf
https://www.sfda.gov.sa/sites/default/files/2022-03/%28002%29.pdf
