Registration in Hong Kong: Devices and Pharmaceuticals

Despite Hong Kong’s reversion to China in 1997, under the terms of its return, Hong Kong is exempt from the rules and regulations outlined above for Chinese medical devices. Hong Kong does require general registration of imported medical devices, but there are only a few basic requirements for their import. In general, imported medical devices must only demonstrate (through certifications, etc.) their adherence to internationally recognized (FDA) and/or British technical and quality standards.

Hong Kong also has special rules with regard to the registration of pharmaceuticals. Pharmaceuticals must be registered with the Pharmacy and Poisons Board, under the Hong Kong Department of Health, before they can be distributed, offered for sale, or sold. For those products manufactured in Hong Kong, the manufacturer is responsible for obtaining registration approval. In the case of imports, responsibility for registration falls on the importer, Hong Kong branch, subsidiary, or representative agent.

Application for registration of a pharmaceutical product is as follows. The application fee is about US$70 and should include: details of composition of the product; specifications of the finished product issued by the manufacturer; a certificate of analysis of a representative batch of the finish product, including the method of analysis; a certified copy of the manufacturer’s license and of the free sale certificate for the product, issued by its country of origin; product samples; one set of original or prototype labels, including container label and outer carton; copies of clinical papers and information on the manufacturing facilities in which the product is produced. In addition, for new chemical entities, additional information is required. Once an application is approved and the registration fee (about US$175 per product) is paid, a certificate of registration will be issued.