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HONG KONG DRUG LICENSING

I want to manufacture a health product in Hong Kong containing some herbal ingredients. Do I need to apply for a pharmaceutical product manufacturer's licence or a licence to manufacture proprietary Chinese medicines?

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

Q64 · Category B: Licence types and scope of application (Q51-Q100)
This is a very good question and reflects forward-thinking about business development. In Hong Kong, pharmaceutical products and medical devices are governed by two separate regulatory systems. Pharmaceutical products 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 operates a voluntary listing system for medical devices, 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 must therefore submit a separate application to the MDD and demonstrate that your company meets the requirements of the Code of Practice for Medical Device Importers and Distributors under the Medical Device Administrative Control System, including having a Quality Management System (such as ISO 13485). The two application processes run in parallel and do not affect each other, but you must meet two different sets of regulations and standards.

📘 Regulatory basis

The main basis for determining product classification is the definitions of “proprietary Chinese medicine” and “food” in the Chinese Medicine Ordinance (Cap. 549) and the Public Health and Municipal Services Ordinance (Cap. 132). A product's ingredients, dosage form, label and promotional claims are all key factors in the assessment.

📗 Drew Tang's recommendations

We strongly recommend consulting us during the product development stage. You can provide the product formulation, draft label design and marketing materials, and we will conduct a professional product classification assessment. We can also make a formal enquiry to the Department of Health or the Chinese Medicine Regulatory Office on your behalf to obtain a clear official determination. This can help you avoid the substantial compliance risks of discovering that the product has been classified incorrectly only after investing heavily in building a factory.

📕 Risk notice

Manufacturing and selling a regulated “proprietary Chinese medicine” as “food” is a serious offence. If substantiated, the product may have to be withdrawn, and the company and persons responsible may face prosecution. This practice of “passing off a medicine as food” is a target of strict regulatory enforcement.

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