One change concerns the total shelf life of a device, which should be more than one year. The device must have at least four months of its shelf life remaining at the port of entry. These revisions help facilitate the launch of a new market pathway for Class I non-sterile medical devices through the Saudi Medical Device National Registry (MDNR).
According to the available information, medical device regulators at the SFDA have also updated deadlines for pending Medical Device Market Application (MDMA) submissions as follows:
- Saudi Arabia Authorized Representatives of overseas Saudi market applicants must submit payment for MDMAs within 30 days of receiving payment requests from the SFDA. Missed payment deadlines will result in applications being deleted.
- Applicants have 60 calendar days to respond to additional information requests from the SFDA. Refunds will not be given for deleted applications if this deadline is missed.
- Returning MDMAs to the SDFDA with incomplete responses to requests for additional information will also result in applications being deleted.
- Applicants may formally ask for additional time beyond the 60-day timeframe to respond to SFDA information requests by emailing the SFDA (firstname.lastname@example.org)
The latest SFDA guidance also includes revisions to the 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 devices 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).
You can find more information about the new regulations regarding the import of medical devices in the SFDA-Guidance document.