Feb 5, 2021

Japan’s Ministry of Health, Labour and Welfare (MHLW) announced the signing of a Memorandum of Cooperation (links in Japanese) on December 14, 2020 with the Saudi Food and Drug Authority (SFDA). This agreement is designed to promote collaboration and cooperation on pharmaceutical and medical device regulatory affairs between the two countries.

Cooperation on medical device regulation is part of a long-term Saudi-Japanese partnership

Other memoranda have previously been signed between elements of the Japanese and Saudi governments as part of a long-term program of partnership for the two countries. A 2017 memorandum between the MHLW and the Saudi Ministry of Health can be found in English here.

Future areas targeted in the memo for collaboration that will pertain to medical devices include strengthening the capacity of the SFDA technical staff by training at the Asian Pharmaceuticals and Medical Devices Training Center of Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), as well as ad hoc consultations with Japanese experts regarding medical device regulation.

Additional medical device and IVD regulatory resources for Japan and Saudi Arabia:

  • Japan PMDA medical device registration and approval consulting
  • Japan PMDA registration support for IVD manufacturers
  • SFDA medical device registration and approval consulting
  • Whitepaper: Clinical data requirements in Japan
  • Whitepaper: Japan’s PMDA Pre-Submission consultation program
  • Whitepaper: Medical device registration in Saudi Arabia


  • Timothy Herr