Jul 13, 2021

The Saudi Food and Drug Authority (SFDA) published a revised version of MDS-G25, Guidance on Requirements for Storage, Handling and Transportation of Medical Devices. The original version of this guidance document appeared in 2018. Version 2.0 features new requirements for importers and distributors involved in the storage, handling, and transportation of medical devices, including the following:

  • The instruments for measuring the temperature and humidity of storage areas (including vehicles used for transportation) are now required to be electronic, to allow both monitoring and the adjustment of values according to instructions provided by the medical device manufacturer.
  • Temperature mapping instruments must be capable of connecting to the electronic systems used by the SFDA.
  • The SFDA has provided a list of eligible facilities that provide temperature and humidity management and tracking services.

Adverse event reporting requirement and change table

The revised guidance also includes an additional requirement for establishments to report any adverse events related to stored or transported medical devices according to MDS-G39, Guidance on Requirements for Reporting and Investigation of Incidents and Adverse Events of Medical Devices.

There is a change history table in Annex 8 that lists the changes introduced in Version 2.0 of the guidance for easy reference.

Medical device regulatory resources for Saudi Arabia from Emergo by UL:

Author

  • Timothy Herr

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