Simplifying Global Compliance
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and a letter from the principal investigator, according to a new draft guidance.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
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