The SFDA Registrations has issued a revised version of MDS-G25, Guidance on Requirements for Storage, Handling and Transportation of Medical Devices. It was initially released in 2018, however, SFDA has revised it including 2 additional points – 
  • Instruments measuring temperature and humidity of storage areas and transport vehicles must be electronic to enable manufacturers to monitor values. 
  • The temperature mapping devices must connect to the electronic systems of the SFDA
  • Manufacturers must adhere to the list provided for eligible facilities of temperature and humidity monitoring.

The SFDA Registrations also included an additional requirement for the reporting of adverse events related to the storage and transport of medical devices as per MDS-G39. 

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