Medical Product Registration in Hong Kong
Registration of Medical Devices in Hong Kong
Registration of Pharmaceuticals/Drugs in Hong Kong
Hong Kong is now a part of China, but as a special administrative region (SAR), it has its own separate medical regulatory system. The Medical Device Control Office (MDCO) regulates medical devices while the Pharmaceuticals Service is in charge of drugs. Both of these agencies are under Hong Kong's Department of Health (DOH).
While Hong Kong has had little legislative control over the import of medical devices in the past, recent changes to Hong Kong's medical device product registration system will create stricter requirements for medical devices in the future. Registration is currently voluntary, but plans for mandatory registration are in development.
Pharmaceutical regulation has not changed as much as medical device registration in the past few years. All drugs must be registered with the Pharmacy and Poisons Board before they can be sold in Hong Kong. Several certifications must be attached to the product registration application, including a Free Sales Certificate from the country of origin, the manufacturer's license, a Good Manufacturing Practice (GMP) certificate, etc.
PBM's expertise will help you navigate the Hong Kong regulatory system, achieve medical product registration, and access Hong Kong's medical markets. PBM will help you register your medical product in a cost-effective and timely way.
For more information on medical product registration in Hong Kong, please see the following PBM publications and/or contact us to discuss your specific needs.
- Looking East for R&D and Clinical Trials
- Updates on Hong Kong's New Medical Device Regulations (webcast for sale)
- A Regulatory Update on Asia's Smaller Medical Device Markets
- Drug and Device Markets throughout the Asian Region (PDF)
- Regulatory Updates for Medical Devices in Asia (PDF)
- Regulatory Updates for Drugs, Devices and IVDs in Asia
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