Compliance with Hong Kong DOH Medical Device and Pharmaceutical/Drug Regulations

Under the Department of the Health (DOH), the Medical Device Control Office (MDCO) and the Pharmaceutical Service are responsible for regulating medical devices and pharmaceuticals in Hong Kong.

Drugs have been regulated in Hong Kong for a longer time than medical devices and are subject to various regulations. There are certain labeling and testing requirements in addition to registering your medical product. Entities must also apply for a license when importing and exporting pharmaceuticals into and out of Hong Kong.

For medical devices, registration has been a voluntary system under the Medical Device Administrative Control System (MDACS). Hong Kong has also issued various guidance notes on listing medical device importers, manufacturers, and conformity assessment.

Pacific Bridge Medical can make sure you are in compliance with Hong Kong regulations and provide the appropriate business or regulatory strategy. We can also help you register your medical product in Hong Kong.

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