Aug 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:

Author

  • Stewart Eisenhart

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EMERGO SUMMARY OF KEY POINTS:

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  • Updates to declaration of conformity and related documentation requirements are also included.
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