FDAnews Device Daily Bulletin

Certificate Needed to Conduct Device Trial in Hong Kong

Nov. 20, 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Health (DH) should submit a copy of the trial protocol and a letter from the principal investigator, according to a new draft guidance.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