Regulatory Strategy for Medical Devices and Pharmaceuticals/Drugs in Hong Kong

Hong Kong is a small market, with a population of about 7 million. It is a wealthy and sophisticated market, however, and it often influences markets in mainland China. While Hong Kong is now part of China, it is governed as a special administrative region.

The Hong Kong medical regulatory system is different than the China medical regulatory system. In Hong Kong, drugs must be registered with the Pharmaceutical Service, which is part of the Department of Health. Medical devices do not require registration yet. However, the Medical Device Control Office (MDCO) registers Class II, III, and IV devices on a voluntary basis. Registration is scheduled to become mandatory in the future. Companies selling or considering selling devices in Hong Kong should consider early registration so that they are prepared for this change.

For more information on regulatory strategies in Hong Kong, please see the following PBM publications and/or contact us to discuss your specific needs.