Hong Kong Drug Licence Applications and Acquisitions · RGYS|Global Licensing and Compliance Service Provider
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HONG KONG DRUG LICENSING

How does the application process differ if my company plans to deal in both medicines and medical devices?

A complete explanation of the regulatory basis, Drew Tang’s recommendations and risk alerts. The original material dates from 2025; read it alongside the latest official requirements.

Original guide, 2025 edition: These FAQs are provided for topic-based reference and have not all been individually checked against current rules. Please confirm fees, personnel, renewal, changes and product requirements against the professional in-depth guide for the relevant licence type and the official requirements in force at the time.

Drug Office, Department of Health Chinese Medicines Board

Q212 · Category E: Application Process and Approval Procedures (Q201-Q250)
This is an excellent question and demonstrates forward-thinking about business expansion. In Hong Kong, medicines and medical devices are governed by two separate regulatory systems. Medicines are regulated by the Drug Office, Department of Health and the PPB, and you need to apply for the various pharmaceutical licences discussed above. Medical devices are regulated by the Medical Device Division (MDD) under the Department of Health. Hong Kong currently regulates medical devices through a voluntary listing system known as the Medical Device Administrative Control System (MDACS). Although listing is voluntary, most importers and distributors apply to list their medical devices to demonstrate product safety and efficacy and to supply public organisations such as the Hospital Authority. You therefore need to submit a separate application to the MDD to demonstrate that your company meets the requirements of the Code of Practice for Importers and Distributors under the Medical Device Administrative Control System, including establishing a Quality Management System (such as ISO 13485). The two application processes run in parallel and do not affect each other, but you must satisfy two different sets of regulations and standards.

📘 Regulatory basis

Medicines are regulated under the Pharmacy and Poisons Ordinance. Medical devices are regulated under the guidelines and codes of the Medical Device Administrative Control System (MDACS). Mandatory registration will be introduced when the Medical Devices Ordinance comes into force.

📗 Drew Tang's recommendations

We recommend that you manage the two applications as separate projects. Rengangyongsheng (Hong Kong) Limited can handle medicines licence applications and provide end-to-end consultancy services for medical device listing. We can help you establish an integrated quality management system that meets the GSP (Good Distribution Practice) requirements for medicines and the ISO 13485 standard for medical devices, delivering an efficient “one system, two licences” management model.

📕 Risk notice

The risk lies in confusing the two sets of quality management requirements. For example, it would be wrong to assume that the temperature and humidity recording method used in pharmaceutical warehouses is entirely suitable for all medical devices. Some medical devices have specific requirements for electrostatic control or light exposure. If these are not reflected in the SOPs, they may be identified as serious deficiencies during an MDD audit or later inspection, affecting your business reputation.

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