Combination Products and Boundary Cases Under Technical Reference TR-010

1. Key takeaways

There are 5 situations in which a listing application should not be filed directly: (1) products whose status as a medical device has not yet been determined; (2) products that meet the device definition but fall outside the scope of the Medical Device Administrative Control System (MDACS) (clause 3.2.1 of GN-01); (3) drug-device combination products whose primary mode of action is undetermined; (4) products containing human organ or human tissue components; and (5) Class I general medical devices and Class A in vitro diagnostic medical devices. What these five share is a single rule: determine the product attribute and the pathway first, then invest in dossier preparation. The cost of rework otherwise far exceeds the cost of the determination itself.

• A product whose device status is unresolved cannot be listed, because the listing system rests on the product being a medical device in the first place.
• Falling within the device definition is not the same as falling within MDACS scope, and the exclusion list in GN-01 has to be checked separately.
• For combination products, the primary mode of action decides whether the product is regulated as a pharmaceutical or as a device.
• Products containing human organs or tissue engage transplant legislation and private healthcare facility rules that sit outside the device framework.
• Class I general devices and Class A IVD devices sit outside the listing requirement, so effort spent on a dossier for them is effort spent on nothing.

2. Legal basis

The determination of combination products is addressed in a dedicated technical reference document, while the scope exclusions and the definitions sit in the overview guidance. The human tissue and pharmaceutical dimensions are governed by ordinances and regulations outside the device framework, and a Department of Health circular of September 2026 addresses the allocation of injectable and infusible products across three categories. The table below records the instruments and provisions used here.

Read together, these instruments show that the device framework does not stand alone. A product can be a device and still be caught by the transplant ordinance, or fall outside MDACS scope, or be reclassified as a pharmaceutical because of how it acts. The determination therefore has to be made against several instruments at once, not against the device definition on its own.

3. Expert insights

First, the test for a combination product is its primary mode of action. TR-010 addresses forms such as drug-device combinations and biological product and device combinations. The outcome of the determination decides whether the product travels down the pharmaceutical products pathway or the device pathway, and the two pathways have entirely different thresholds, timelines and responsible parties. Choosing the wrong one means starting again, which is why the analysis should be documented rather than settled by internal assumption.

Second, regulation of human tissue products operates at three levels. Products containing processed human organs or tissue intended for transplantation are regulated under Cap. 465. Where such products are used in a licensed private healthcare facility, they are also subject to Schedule 3 of the Private Healthcare Facilities Ordinance (Cap. 633): transplanting any cells, tissue or organ is a procedure described in column 2 of Schedule 3, and except for the procedures listed in column 3, injection or infusion cannot be carried out in a clinic. The practical effect is that the setting of use, and not only the product, determines what is permissible.

Third, the exemption provision is a key practical outlet. Regulation 36(1A) of Cap. 138A sets out the circumstances in which registration may be exempted, for example a pharmaceutical product possessed or to be used by a registered medical practitioner or registered dentist for the treatment of a particular patient. Such exemptions are patient-specific and do not create a channel for supply in volume. Treating an exemption as a distribution route is a misreading that carries regulatory consequences for the supplier as well as for the practitioner.

Fourth, the sequence for the five situations is fixed. Attribute, then scope, then mode of combination, then tissue component, then classification. Skipping a step is the main cause of rework. A project that begins with classification before resolving attribute may produce a class for a product that is not regulated as a device at all, and a project that begins with dossier drafting before resolving scope may produce a complete file for a product that does not need one.

4. Practical recommendations

• Issue the determination before project approval. Treat the attribute determination as a deliverable that gates the project, and do not start dossier preparation until the conclusion is documented.
• Analyse the mode of action for combination products. Write out the technical argument for the primary mode of action, and obtain an external expert opinion where the argument is finely balanced.
• Check Cap. 465 and Cap. 633 first for human tissue products. Confirm whether an exemption from the Director of Health is required, and confirm the category of premises in which the procedure may be carried out.
• Seek written replies for borderline products. Enquire in writing to the Medical Device Division (MDD) or to the Pharmacy and Poisons Board and retain the reply, so that it can serve as a compliance record in later tenders.

5. Verification checklist

• □ The determination of whether the product is a medical device is complete
• □ The exclusion list in clause 3.2.1 of GN-01 has been checked
• □ The primary mode of action of any combination product has been determined under TR-010
• □ Products containing human tissue components have been checked against Cap. 465 and Cap. 633
• □ Classification is complete and the product is confirmed to fall within listing scope
• □ Written enquiry replies for borderline products are on file

Regulatory information verified to 29 October 2026. The legislation, guidance and effective dates described in this article are limited to what the official sources listed under Legal basis had published on that date; where an official document has since been updated, the most recent published version prevails.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for Hong Kong, China. Our team manages MDACS listing applications across all risk classes, prepares reference-approval dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com