Additional Updates to Saudi Arabian Clearance Policy for Medical Device Shipments
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CONTACT USAug 8, 2018
EMERGO SUMMARY OF KEY POINTS:
- The Saudi Food and Drug Administration (SFDA) has issued another update to its clearance policy for medical device shipments to the country.
- The updates cover shelf-life requirements, last revised earlier in 2018.
The Saudi Food and Drug Authority (SFDA) has published an update to its requirements for clearance of medical device shipments at Saudi ports of entry.
Latest updates to the SFDA guidance pertain to shelf life requirements, which were previously revised in May 2018.
Specifically:
- If the total shelf life of a device is less than one year, the device must have at least 25% of its shelf life remaining at the port of entry.
- If a device’s shelf life is more than one year, the device must have at least four months of its shelf life remaining at the port of entry.
As previously reported by Emergo, SFDA’s revisions to its medical device shipping policies to help facilitate the launch of a new market pathway for Class I non-sterile, non-measuring devices through the Saudi Medical Device National Registry (MDNR). Less burdensome market entry requirements for low-risk devices may result in increased shipments of such products to Saudi Arabia, necessitating faster processing at points of entry.
Learn more about Saudi Arabian medical device regulations:
- Saudi Arabia SFDA medical device registration and approval consulting
- Saudi Arabia Authorized Representative in-country representation
Author
- Stewart Eisenhart
Related
Final Guidance on Saudi Arabia’s Medical Device National Registry (MDNR) Route Published
EMERGO SUMMARY OF KEY POINTS:
- The Saudi Food and Drug Authority (SFDA) has issued final guidance on its Medical Device National Registry (MDNR) market pathway for low-risk devices.
- The final guidance includes additions and clarifications to MDNR flowchart and declaration of conformity requirements.
- MDNR listing requirements for Class I non-sterile, non-measuring devices will go into effect in September 2018.
Saudi Regulators Update Requirements for Medical Device Shipments
EMERGO SUMMARY OF KEY POINTS:
- The Saudi Food and Drug Authority has updated its policies for clearing medical device shipments at Saudi points of entry.
- The revised requirements include changes to how long devices may be held at ports of entry according to shelf-life criteria.
- Updates to declaration of conformity and related documentation requirements are also included.
Saudi Regulators Extend Deadline for Low-risk Medical Device Registrations
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.