Saudi Arabia: Revision Guidance on Storing, Handling & Transportation of medical devices

A revised version of Guidance on Requirements for Storage, Handling and Transportation of medical Devices: MDS-G25 has been published.

New updates mainly includes:

1. It is now required that all instruments used to measure temperature and humidity in storage (and vehicles used to transport a medical device) must be electronic, in order to be able to monitor the values and adjust them according to instructions provided by the manufacturers.

2. A temperature mapping instrument must be able to connect to the SFDA's electronic systems.

3. A list of eligible facilities that provide temperature and humidity management and tracking services has been provided.

In related to this, a revised version of Guidance on Requirements for Reporting and investigation of Incidents and Adverse Events of Medical Devices: MDS-G39. This includes additional requirements to report any adverse events related to store or transport medical devices.

Source:

MDS-G225 Version 2: https://beta.sfda.gov.sa/sites/default/files/2021-06/%2839%29-17-06-2021En%20v2.pdf

MDS-G225 Version 1: https://www.sfda.gov.sa/sites/default/files/2019-10/%28MDS-G25%29en.pdf

https://www.sfda.gov.sa/en/service_providing_facilities

MDS_G39 Requirements for Medical Devices Advertising: https://sfda.gov.sa/sites/default/files/2020-09/MDS-G39e.pdf

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