Labelling and instructions for use: TR-005 supplementary rules and bilingual practice

1. Key takeaways

Labelling requirements for medical devices in Hong Kong, China operate on two layers. TR-005, Supplementary Requirements for Labelling of Medical Devices, sets the additional requirements under MDACS. The Consumer Goods Safety Regulations, subsidiary legislation under Chapter 456, require that any warning or caution on the packaging or labelling of consumer goods supplied for private use be expressed in Chinese and English and be clearly legible. The two layers apply cumulatively. The error most often made by manufacturers from the Chinese mainland sits in the second layer: reusing a simplified Chinese instruction leaflet without producing a bilingual text or converting it to traditional Chinese.

Because the two layers come from different legal sources, they are enforced by different authorities and fail in different ways. A label can satisfy the device requirements and still breach the consumer goods requirements.

• Supplementary means additional. TR-005 adds to the labelling requirements found in other applicable legislation; it does not replace them.
• The language rule has its own legal source. The bilingual warning requirement comes from the consumer goods safety regulations, not from MDACS.
• Enforcement runs on two tracks. Chapters 456 and 362 are enforced by Hong Kong Customs, while MDACS sits with the Department of Health.
• Labels are examined during listing. Defects surface at assessment, not only after the product reaches the market.
• Consistency across three documents is the test. Label, instructions for use and promotional material must describe the same intended purpose.

2. Legal basis

TR-005 supplies the device-specific supplementary requirements and is the document a reviewer reads when assessing the labelling part of a listing file. The Consumer Goods Safety Ordinance and its subsidiary regulations supply the general safety duty and the bilingual warning rule for consumer goods. The government position on how consumer goods rules reach products such as contact lenses is recorded in a Legislative Council reply published on 9 July 2025. GN-02 sets the labelling submission requirements within the dossier.

The presence of a Legislative Council reply in the legal basis is a reminder that the boundary of the consumer goods regime is not self-evident. Products that look like devices to a manufacturer, such as contact lenses, can also be consumer goods for the purposes of Chapter 456, which brings the bilingual warning rule into play alongside the device rules.

3. Expert insights

TR-005 is supplementary, not complete. The word in the title matters: the MDACS labelling requirements are an additional layer on top of other applicable legislation. Where the product is also a consumer good, the requirements of Chapter 456 apply as they stand. A team that treats TR-005 as the whole requirement set will produce a label that satisfies the device reviewer and still fails the consumer goods test.

The language requirement comes from the consumer goods safety regulations, not from MDACS. In reply to a Legislative Council question the government stated clearly that the Consumer Goods Safety Regulations require any warning or caution on packaging or labelling to be expressed in Chinese and English and to be clearly legible. That is a mandatory requirement for products supplied for private use, and it applies irrespective of what the device guidance notes say about content.

Enforcement sits with Hong Kong Customs. Chapters 456 and 362 are enforced by Hong Kong Customs, which is a separate line from the Department of Health system that operates MDACS. A labelling rectification notice may therefore come from Customs rather than from MDD, and manufacturers should maintain two points of contact rather than assuming that a satisfied device reviewer means a satisfied regulator.

Labelling is part of the listing information. The official overview of the process lists device labelling, covering instructions for use, manuals, labels and specific listing information, among the required documents. Labelling is therefore examined at the listing stage, and problems surface during assessment rather than waiting for the post-market phase. That timing is a benefit to the applicant, provided the label is drafted early enough to be reviewed.

Translation is not localisation. Converting a simplified Chinese text into traditional characters is a mechanical step; adapting terminology to the medical vocabulary used in Hong Kong, China is not. A label that is linguistically traditional but terminologically foreign reads as a mainland document with a font change, which undermines confidence in the file as a whole.

4. Practical recommendations

• Design bilingual from the start. For products supplied for private use, reserve space for both language versions at the structural design stage rather than shrinking text later.
• Convert to traditional Chinese and localise terminology. Use traditional characters and adjust terms to those commonly used in Hong Kong, China instead of transplanting mainland usage.
• Proof consistency across three documents. Intended purpose and warnings must agree across the label, the instructions for use and promotional material.
• Keep compliance records. Archive the final label version, the language proofreading record and the regulatory comparison table together.
• Map both regulators. Identify whether the product is a consumer good under Chapter 456 and record which authority would raise a labelling issue.

5. Verification checklist

• □ The supplementary labelling requirements in TR-005 have been checked.
• □ Consumer-facing warnings appear in both Chinese and English.
• □ The Chinese text uses traditional characters with local terminology adjustments.
• □ The intended purpose is expressed consistently in the label, the instructions for use and promotional material.
• □ Whether the product is a consumer good under the Consumer Goods Safety Ordinance has been confirmed.
• □ The final label and the regulatory comparison table have been archived.

Regulatory information verified as at 29 October 2026. The legislation, guidance and effective dates described in this article are limited to the content published by the official sources listed under legal basis on that date; 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 prepares MDACS-compliant dossiers, coordinates evidence of reference approvals and ISO 13485 certificates, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com