Five Ordinances That Still Catch Medical Devices in Hong Kong, China

1. Key takeaways

Hong Kong, China has no ordinance named after medical devices, yet devices are far from unregulated. Depending on the characteristics of the product, at least 5 ordinances in force may apply, alone or together: the Pharmacy and Poisons Ordinance (Cap. 138), the Radiation Ordinance (Cap. 303), the Trade Descriptions Ordinance (Cap. 362), the Consumer Goods Safety Ordinance (Cap. 456) and the Electrical Products (Safety) Regulation (Cap. 406G). The test is not whether a product is a medical device, but whether the product meets the trigger condition of a particular ordinance. In practice one product can be caught by 2 or more ordinances at the same time, a practical estimate drawn from how enforcement is organised rather than a published rule.

This changes the shape of a compliance review. A device that sits comfortably inside MDACS may still be a consumer good, a radiopharmaceutical precursor, an electrical product or a medicinal product for the purposes of another ordinance, and each of those characterisations brings a different authority, a different evidence standard and a different penalty. The five ordinances do not form a hierarchy with MDACS at the top; they overlap.

The GRZAN view. Most cross-border failures on first import are labelling failures, not technical failures, and they are cheaper to prevent at the design stage than to correct after the goods land.

2. Legal basis

Product characteristics, not regulatory categories. The ordinances each define their own scope. Cap. 138 governs pharmaceutical products and the registration obligations attached to them, with Cap. 138A providing the procedural detail; regulation 36(1A) of Cap. 138A allows exemption from registration in stated circumstances or on stated conditions. Cap. 303 controls irradiating apparatus and radioactive substances. Cap. 362 prohibits false trade descriptions and misleading omissions. Cap. 456 imposes a general safety duty, and its subsidiary regulations require warnings or cautions on packaging or labelling to be in Chinese and English and to be clearly legible. Cap. 406G sets safety specifications for electrical products. The government position on the existing regime is recorded in the joint response of the Health Bureau and the Department of Health, press release P2024011500706 of 15 January 2024.

Enforcement sits with more than one department. Cap. 456 and Cap. 362 are enforced by Hong Kong Customs, while MDACS is administered by the Medical Device Division of the Department of Health. The two do not share a complaint channel, an appeal route or a set of evidence requirements, which matters operationally when a single product attracts attention from both.

3. Expert insights

The trigger is product characteristic, not regulatory classification. Contact lenses are the clean illustration. For MDACS purposes they are medical devices. At the consumer goods level, sold for private use, they are also subject to Cap. 456 and Cap. 362, with Hong Kong Customs as the enforcing authority. A compliance review therefore has to run on two axes at once, the intended user and the product characteristics, rather than against a single product list. A file organised only by MDACS class will miss the consumer goods dimension entirely.

The Cap. 138 and Cap. 456 boundary sets the cost of the pathway. A product that falls within the definition of a pharmaceutical product must travel the registration route of the Pharmacy and Poisons Board, and the threshold and duration are far higher than a listing under MDACS. Regulation 36(1A) of Cap. 138A provides for exemption in defined circumstances, for example a pharmaceutical product possessed or used by a registered medical practitioner or registered dentist for the treatment of a particular patient. That provision is the legal hinge for many cases of clinically urgent import, and it is narrow: it addresses a named patient, not a stock position.

Bilingual warnings are a hard requirement that is routinely missed. The Consumer Goods Safety Regulations require warnings or cautions to be expressed in Chinese and English and to be clearly legible. Manufacturers from the Chinese mainland often carry over a simplified Chinese leaflet unchanged, and the gap is discovered at the label stage after import, when rework costs concentrate in packaging and printing. The exposure is not only the reprint: a misleading or missing warning can also engage Cap. 362.

Decisions need to be documented, not remembered. Because the same product may be assessed by two authorities on different tests, the reasoning behind an attribute decision is itself evidence. A short written determination per model, dated and signed, is far more useful in a tender query or an inspection than a recollected conversation.

4. Practical recommendations

• Build an ordinance trigger table. For every model, answer four questions: is it a pharmaceutical product, does it contain radiating or radioactive components, is it a consumer good for private use, and is it an electrical product. Any yes activates the corresponding ordinance and its enforcing authority.
• Design labels before the artwork freeze. For consumer-facing products, set warnings in Chinese and English side by side at the design stage, so that compliance does not force a second print run.
• Separate the enforcement channels. Cap. 456 and Cap. 362 are handled by Hong Kong Customs and MDACS by the Medical Device Division; the two do not accept the same submission, so complaints and remediation must be routed separately.
• Keep an audit trail of determinations. Retain the written record of each attribute decision as compliance evidence for tenders, inspections and disputes.
• Re-run the test after any change. A new claim, a new accessory or a move from professional to home use can activate an ordinance that did not previously apply.

5. Verification checklist

• □ Attribute determination completed per model: pharmaceutical product, device or consumer good.
• □ Electrical safety products checked against Cap. 406G.
• □ Products with radiating components checked for licence needs under Cap. 303.
• □ Consumer goods labelling carries warnings in both Chinese and English.
• □ For the pharmaceutical route, applicability of regulation 36(1A) of Cap. 138A confirmed.
• □ Import licence requirement under Cap. 60 confirmed at the import stage.
• □ Determinations documented in writing with the verification date recorded.

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 manages Medical Device Administrative Control System (MDACS) listings, coordinates import licensing, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com