Import and Logistics Compliance: Cap. 60, Cap. 303 and Cap. 406G

1. Key takeaways

Hong Kong, China has no dedicated import licensing regime for medical devices, and completing an MDACS listing does not constitute import approval. Those two statements are separate and both are correct: the device regime is silent on the border, and the border regime is silent on devices.

Additional requirements can nevertheless be triggered by product characteristics under 3 pieces of legislation. Under the Import and Export Ordinance (Cap. 60), the import of pharmaceutical products requires a valid import licence. Under the Radiation Ordinance (Cap. 303), irradiating devices or devices containing radioactive substances require a licence. Under the Electrical Products (Safety) Regulation (Cap. 406G), electrical products must comply with the applicable safety specifications.

The order of analysis therefore matters more than the list. Establish the product characteristics first, then identify which ordinance is engaged, then confirm who must hold the licence. Working in the reverse order, from a licence that a distributor happens to hold, produces confident answers to the wrong question.

2. Legal basis

The Import and Export Ordinance, Cap. 60, contains the provisions on import licences, and applies to the import of pharmaceutical products. The Radiation Ordinance, Cap. 303, contains the provisions on licences for irradiating apparatus and radioactive substances. The Electrical Products (Safety) Regulation, Cap. 406G, contains the safety specification provisions for electrical products. The Pharmacy and Poisons Regulations, Cap. 138A, at regulation 36(1A), contains the exemption from registration. The Department of Health Office for Regulation of Private Healthcare Facilities, in its letter of 9 September 2026 on injectable and infusible products, states at item A2 that the import of pharmaceutical products requires a valid import licence under Cap. 60. GN-02, Guidance Notes on Listing of Class II, III and IV General Medical Devices, in its current version verified to 29 October 2026, lists relevant Hong Kong, China licence requirements, including those under Cap. 303, among the documents required for a listing application.

The structure explains why the three ordinances are often overlooked. None of them is a medical device instrument, so none appears in a device-focused reading of the regime. They are general commercial, radiation safety and product safety instruments that apply to devices only because a device happens to fall within their subject matter.

3. Expert insights

Listing and import licensing are two independent channels. A listing does not exempt a product from any import licensing requirement, and an import licence does not mean the product is listed. The two operate at different points in the supply chain: one governs product eligibility, the other governs the movement of goods. A shipment can be perfectly licensed and the product entirely unlisted, or the reverse, and neither condition cures the other.

The import licensing requirement for pharmaceutical products is the clearest of the three. The Department of Health states at item A2 of its letter on injectable and infusible products that the import of pharmaceutical products must hold a valid import licence under Cap. 60 of the Import and Export Ordinance. The point is particularly important in clinically urgent import scenarios, where the pressure of a clinical need can lead a hospital or supplier to treat the licensing step as a formality to be completed afterwards.

The Cap. 303 licence is part of the listing application file. The official overview of the listing process lists relevant Hong Kong, China licences, such as a licence under the Radiation Ordinance, Cap. 303, among the documents required for a listing application. The licence is therefore a precondition of the listing, not a parallel workstream. A project plan that schedules the radiation licence alongside the dossier rather than before it will slip at the submission gate.

Electrical product compliance is the requirement most easily missed. Powered large equipment and household therapeutic devices are electrical products and must meet the safety specifications under Cap. 406G. Manufacturers from the Chinese mainland frequently assume that CCC certification or IEC test reports already satisfy the requirement, and thereby overlook the local compliance step. The assumption is understandable and wrong: conformity in another market is evidence, not a substitute for the local requirement.

Storage and transport evidence serves two purposes at once. Records of storage and transport conditions support the logistics process, and they are also within the scope of a site inspection under clause 4.10 of GN-08. Maintaining one accurate record set therefore satisfies a commercial need and a regulatory exposure with the same effort.

4. Practical recommendations

• Build a category trigger list. For each model, answer whether it is a pharmaceutical product, whether it contains radioactive material or emits radiation, and whether it is an electrical product. A yes to any one of the three triggers the corresponding ordinance.
• Sequence the licence before the listing. A Cap. 303 licence is required at the time of listing application, so it should be pursued while the dossier is being prepared rather than after submission.
• Put logistics into the quality system. Storage and transport condition records should be producible on request, because the site inspection under GN-08 clause 4.10 covers those facilities.
• Use the dedicated channel for pharmaceutical products. Where a product is a pharmaceutical product, obtain the import licence under Cap. 60, and check whether the exemption in regulation 36(1A) of Cap. 138A applies.
• Do not treat foreign certification as local compliance. Map each electrical product against Cap. 406G explicitly, and record the basis for any conclusion that an existing test report satisfies it.

5. Verification checklist

• □ Whether the product is a pharmaceutical product confirmed, triggering the Cap. 60 import licence.
• □ Whether the product contains radioactive material or emits radiation confirmed, triggering the Cap. 303 licence.
• □ Whether the product is an electrical product confirmed, triggering Cap. 406G.
• □ Cap. 303 licence obtained and submitted with the listing application.
• □ Storage and transport condition records available for site inspection.
• □ Applicability of the exemption in regulation 36(1A) of Cap. 138A checked.
• □ Foreign certification mapped against the local safety specification requirement rather than assumed to satisfy it.

Regulatory information verified as at 29 October 2026 against the official sources listed under legal basis; where those sources are updated, the latest 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 coordinates local responsible persons, import and wholesale dealer licensing, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com