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.

The Saudi Food and Drug Authority (SFDA) has published revised requirements for clearing imported medical devices at Saudi ports of entry.

The most recent SFDA guidance for shipment clearances at Saudi ports of entry comes as the regulator works to implement a new market pathway for Class I non-sterile, non-measuring devices that only require listing in the Saudi Medical Device National Registry (MDNR) rather than full registration via Medical Device Marketing Authorization (MDMA). (The MDNR pathway is expected to be fully implemented in September 2018.)

Establishing a faster market pathway for low-risk devices may lead to higher volumes of device shipments to Saudi Arabia, necessitating revisions to clearance processes.

Changes to device product shelf life criteria

 Previous guidance on shipping clearance required that devices whose shelf lives are between one and two years must be held at Saudi ports of entry for no less than half their shelf lives. Now, products with one- to three-year shelf lives are to be held for no less than half their shelf lives at ports of entry before clearance.

Additional changes for medical device shipments to Saudi Arabia

The latest SFDA guidance also includes revisions to declaration of conformity and other documentation requirements.

Declarations of conformity to SFDA medical device interim regulations, for example, are required for devices listed in the Saudi MDNR or with MDMA registrations. These declarations are required in addition to declarations of conformity to Global Harmonization Task Force (GHTF) market regulators (the US, Europe, Australia, Japan and/or Canada).

Additional Saudi Arabian medical device regulatory information:

• Saudi Arabia SFDA medical device registration consulting
• Saudi Arabia Authorized Representative in-country representation
• Certificate of Free Sale (CFS) support for medical device exporters