Hong Kong: Expedited Approval of Class II/III/IV Medical Device


The Hong Kong Medical Device Control Office (MDCO) will launch an Expedited Approval trial scheme to streamline application and approval process of Class II/III/IV general medical device listing applications with established support on proven safety and performance.

Only listed local responsible persons (LRP) are eligible to participate into the trial scheme. The trial will commence from 1 September 2019 to 30 June 2020. The applicant can make no more than two applications each time.

More details at https://www.mdco.gov.hk/english/news/news_20190820.html

Contact us at info@arqon.com


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