Hong Kong's Department of Health (DOH)

The DOH serves as Hong Kong's executive arm for health regulations and policy. Within the DOH, the Medical Device Control Office (MDCO) and the Pharmaceutical Service Department of Health (PSDH) handle medical devices and pharmaceuticals regulations.

Established in 2004, the MDCO promotes risk-based and cost-effective regulations for medical devices. To ensure the safety, efficacy, and quality of medical devices, the MDCO has adopted the standards and procedures of the Global Harmonization Task Force (GHTF). Other functions of the MDCO include publishing a list of regulated medical devices for public reference, raising awareness on the safe use of medical devices, and working with manufacturers to expedite the regulatory process.

The Pharmaceutical Service Department of Health serves as the law enforcement agency for the regulation of pharmaceuticals. It assesses applications for pharmaceuticals based on their conformity to the Pharmacy and Poisons Ordinance, the Antibiotics Ordinance, and the Dangerous Drugs Ordinance. In order to ensure compliance, the Pharmaceutical Service inspects manufacturers, wholesalers, and retailers and collects product samples for analysis. In addition to overseeing pharmaceutical registration and licensing, it also oversees procurement and distribution of drugs by the DOH clinics.

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