Hong Kong Advises Devicemakers on In Vitro Device Applications

Devicemakers seeking to market an in vitro diagnostic device in Hong Kong should provide the Medical Device Control Office (MDCO) with both a paper and electronic copy of the MD-IVD application form. If the manufacturer has a place of business in Hong Kong, it should indicate this in the application and provide a copy of the business registration, the MDCO says in a guidance posted on its website this month.
International Medical Device Regulatory Monitor