Compliance with Hong Kong DOH -- Regulations for Medical Devices, Pharmaceuticals, and Drugs
Does your organization have regulatory compliance questions about the Hong Kong Department of Health? Pacific Bridge Medical (PBM) consultants can help you navigate Hong Kong's medical regulations and set your organization on a path towards success. Whether you are seeking approval for medical devices or pharmaceuticals and drugs, we have the expertise you need.
What To Know About the Hong Kong DOH
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.
Contact PBM for Regulatory Compliance Help in Hong Kong
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 and find medical distributors in Hong Kong.
To learn more about the ways we can help, please contact us online for a free consultation. You can also read the publications listed below that have been written by our regulatory compliance consultants for Asia.
Hong Kong Webcasts
- 2012 Hong Kong Medical Device Regulatory Update
- 2008 Managing Asian Cultural/Business Diversity
- 2008 Updates on Hong Kong's New Medical Device Regulations
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