Saudi Regulators Extend Deadline for Low-risk Medical Device Registrations
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CONTACT USMay 8, 2018
EMERGO SUMMARY OF KEY POINTS:
- Saudi regulators have delayed enforcement of a new expedited market pathway for Class I non-sterile, non-measuring medical devices.
- Starting in September 2018, qualifying devices may apply for listing in the Saudi Medical Device National Registry (MDNR) without undergoing full SFDA review.
The Saudi Food and Drug Administration (SFDA) has pushed back compliance deadlines for a new registration pathway for low-risk medical devices.
According to a notice (link in Arabic) published by the SFDA, enforcement deadlines for Class I non-sterile, non-measuring devices to register under the new Medical Device National Registry (MDNR) market authorization pathway have been moved from May to September 2018.
As previously reported by Emergo, the new route will enable qualifying manufacturers to list their products in the Saudi MDNR without undergoing full Medical Device Marketing Authorization (MDMA) review.
After the September 2018 deadline, Class I non-sterile, non-measuring devices will have to meet SFDA MDNR requirements in order to enter the Saudi market. SFDA extended its enforcement deadline to prevent any disruptions to healthcare provider and patient access to these devices.
Related Saudi Arabian medical device market resources from Emergo:
- Saudi Arabian medical device registration consulting
- Saudi Arabia Authorized Representative in-country representation
- Certificate of Free Sale (CFS) support for medical device exports
Author
- Stewart Eisenhart
Related
MDMA or MDNR: Which Saudi Arabian Registration Route is Better for Low-risk Medical Devices?
EMERGO SUMMARY OF KEY POINTS
- Low-risk medical device manufacturers may now choose between Medical Device Market Application (MDMA) and Medical Device National Registry (MDNR) registration pathways in Saudi Arabia.
- The SFDA’s MDNR route is faster, but some Class I non-sterile, non-measuring device manufacturers may still benefit more by undergoing MDMA registration.
Medical Device Marketing Authorization (MDMA) Application Changes Planned in Saudi Arabia
EMERGO SUMMARY OF KEY POINTS:
- The Saudi Food and Drug Authority plans to require more clinical data for some Medical Device Marketing Authorization (MDMA) applications.
- Details and timeframes for the new requirements are forthcoming from the SFDA.
- Additional clinical data the SFDA may require of applicants includes clinical evaluation reports (CER), post-market surveillance plans and post-market clinical follow-up (PMCF) reports.