Advertising and Promotion Compliance: The Boundaries of Cap. 362 and Cap. 231

1. Key takeaways

Consumer-facing promotion of medical devices in Hong Kong, China is governed by 2 ordinances. The Trade Descriptions Ordinance (Cap. 362) covers goods and services and prohibits false trade descriptions, misleading omissions, aggressive commercial practices, bait advertising, bait-and-switch and wrongly accepting payment, and it applies to physical and online traders alike. The Undesirable Medical Advertisements Ordinance (Cap. 231) regulates statements in medicinal-related advertising.

Enforcement sits with the Customs and Excise Department for Cap. 362 and with the relevant authorities for the advertising restrictions, which places this subject on a different track from MDACS and the Department of Health device system. A company can be fully compliant with its listing obligations and still commit an offence in a social media post.

The practical consequence is that advertising review cannot be delegated to the regulatory affairs function alone. It requires a review step that compares the proposed wording against the intended use declared at listing, and that step has to apply to the same content whether it appears in a printed brochure, an e-commerce page or a short video.

2. Legal basis

The Trade Descriptions Ordinance, Cap. 362, prohibits false trade descriptions, misleading omissions, aggressive commercial practices, bait advertising, bait-and-switch and wrongly accepting payment, and applies to goods and services. The Undesirable Medical Advertisements Ordinance, Cap. 231, contains the provisions regulating medicinal-related advertising. The Consumer Goods Safety Ordinance, Cap. 456, contains the general safety provisions. The government reply to a Legislative Council question, press release P2025070900329 of 9 July 2025, records that the Customs and Excise Department enforces Cap. 456 and Cap. 362. TR-005, Technical Reference Document on Additional Labelling Requirements for Medical Devices, in its current version verified to 29 October 2026, sets out the additional labelling requirements, which supply much of the wording that advertising then reuses.

The division of enforcement responsibility is the feature of this legal basis that applicants most often miss. Cap. 362 is enforced by the Customs and Excise Department, not by the Department of Health, and Cap. 456 sits with the same authority. A compliance programme that reports only into the device regulatory channel therefore has no line of sight to the authority that would actually investigate a promotion complaint.

3. Expert insights

Cap. 362 governs trading conduct, not product technology. It constrains the commercial practices a trader applies to consumers and lists 6 categories of undesirable practice. This regulatory logic is entirely different from technical product compliance, and the distinction has a blunt implication: a fully compliant product can still be advertised unlawfully. Nothing in a listing certificate prevents a claim from being a false trade description.

Online traders are held to the same standard as physical traders. The ordinance expressly applies to the trading conduct of both physical and online traders. When a manufacturer from the Chinese mainland promotes to consumers in Hong Kong, China through e-commerce platforms or social media, that promotion falls within scope. The channel is not a jurisdiction, and the absence of a physical shopfront in Hong Kong, China does not remove the exposure.

The government has published enforcement data that can serve as a risk reference. In answering a Legislative Council question, the government stated that between 2022 and 2024 the Customs and Excise Department received no complaints about the safety of contact lens products, but did receive 6 complaints alleging breach of the Trade Descriptions Ordinance, of which 5 were closed for insufficient evidence and 1 remained under investigation. The figures are modest, and that is the point: the complaint channel exists and complaints are counted. A low absolute number reflects the size of the market, not the absence of enforcement capability.

Advertising wording has to match the declared intended use. The intended use declared at listing is the compliance baseline for promotional claims. An indication that appears in advertising but falls outside the declared scope may breach Cap. 362 and may also trigger a variation notification obligation under GN-10. The same sentence can therefore create two separate problems under two separate regimes, which is why the two review processes should be connected rather than run in parallel by different teams.

Absolute claims are the recurring failure point. Words asserting cure, permanent resolution, superiority or the absence of side effects are the claims most likely to be read as false or misleading, and the ones most likely to be written by a marketing team without regulatory input. A prohibited-word list is a crude instrument, but it is effective precisely because it operates before the copy is written rather than after.

4. Practical recommendations

• Create an approval step for promotional wording. Before any consumer-facing copy for Hong Kong, China is published, compare it against the intended use declared at listing and record the approval.
• Maintain a high-risk wording list. Place absolute and efficacy claims, including words asserting cure, eradication, best performance or absence of side effects, on a prohibited list with no exceptions without regulatory sign-off.
• Apply one standard across channels. Run e-commerce pages, social media content and printed materials through the same approval process, since the ordinance does not distinguish between them.
• Prepare a complaint response procedure. Define who receives a complaint, who responds and whether the LRP or the local distributor leads, before the first complaint arrives.
• Localise the wording deliberately. Check that the Chinese version of promotional material is accurate in traditional characters and in local terminology, since a translation error can itself create a misleading statement.

5. Verification checklist

• □ Promotional copy compared against the intended use declared at listing.
• □ Prohibited-word list established for absolute and efficacy claims.
• □ Same approval process applied to online and physical channels.
• □ Whether the material falls within the scope of Cap. 231 confirmed.
• □ Complaint receipt and handling procedure assigned to a named responsible party.
• □ Chinese version of promotional material checked for traditional characters and local terminology.
• □ Advertising claims reviewed for any consequential obligation under GN-10.

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