www.fdanews.com/articles/122342-certificate-needed-to-conduct-device-trial-in-hong-kong
Certificate Needed to Conduct Device Trial in Hong Kong
November 19, 2009
Devicemakers seeking a Certificate for Clinical Trial from Hong Kong’s Department of Health (DH) should submit a copy of the trial protocol
and a letter from the principal investigator, according to a new draft guidance. Proposed legislation in Hong Kong would require most devices to be registered
with the DH, but those that must be tested in clinical trials would need a certificate.
International Medical Device Regulatory Monitor
International Medical Device Regulatory Monitor