Personalised Medical Devices Under Technical Reference TR-009

1. Key takeaways

Personalised medical devices are specifically regulated in Hong Kong, China by technical reference document TR-009, Personalised Medical Devices, which was updated on 2 October 2025 with a Chinese version published on the same date. The listing pathway itself does not change: it still follows classification and runs through GN-02 or GN-06. The difference lies on the documentation side, because a personalised device has to explain the patient-matching process, the source of design inputs, the verification method and traceability. There are three situations in which the routine pathway should not be applied directly: devices produced in batches without individual design input, standard product families that differ only in size or specification, and devices made in-house by a hospital and not entering commercial supply.

• The personalised question is whether a specific patient supplied design input, not whether the product is made in small quantities.
• Selecting a size from an existing range is specification coverage within a standard family, not personalisation.
• Traceability from finished device back to a named patient is the core evidence, and a missing link produces a supplementation request.
• Where design output is generated by an algorithm, TR-008 applies at the same time as TR-009.
• Local manufacturer listing may suit devices designed and made in the city, but it brings site inspection obligations with it.

2. Legal basis

TR-009 governs the classification and documentation of personalised devices, while the classification rules themselves sit in TR-003 and the application requirements sit in GN-02. TR-008 addresses the cases in which personalisation and artificial intelligence overlap. The table below records the instruments and provisions used in this article.

The division of labour between these documents is straightforward. TR-003 decides the class, GN-02 decides what the application contains, and TR-009 decides what has to be added because the device is made for a particular patient. None of the three displaces the others, and a personalised device still needs the ordinary classification work to be completed properly before the additional documentation is layered on top.

3. Expert insights

First, personalised does not mean that every unit is different. The key question in TR-009 is whether there is design input specific to a particular patient. Choosing a size from within an existing model range is specification coverage within a standard product family and does not trigger the personalised device documentation requirements. An implant reconstructed from patient imaging data and designed individually does fall within them. The distinction matters commercially, because treating a standard family as personalised adds documentation burden without any regulatory benefit, while treating an individually designed implant as standard invites a supplementation request.

Second, traceability is the core evidence. The dossier for a personalised device has to answer three questions: where the design input came from, who verified the design process, and how the finished device can be traced back to a specific patient. If any one link is missing, supplementation follows. The three questions map naturally onto three documentary sets, which is why they are worth using as the organising structure for the volume rather than as a checklist applied at the end.

Third, there is an overlap with artificial intelligence devices. Where the personalised design is generated automatically by an algorithm as design output, TR-008 applies as well. The documentation volume for such products is roughly twice that of a conventional device (practical estimate). Planning the file as two parallel structures from the start is more efficient than drafting a single narrative and attempting to split it later.

Fourth, the local manufacturer role may be the better fit. A personalised device designed and manufactured within Hong Kong, China may be considered for local manufacturer listing under GN-08, but that route carries the obligation to cooperate with a site inspection under clause 4.10. The choice between LRP-based device listing and local manufacturer listing therefore turns on where design and manufacture actually take place, and on whether the organisation can support inspection of its premises and records.

4. Practical recommendations

• Complete a personalisation determination first. Establish clearly whether design input specific to a patient exists, and write the conclusion as a one-page statement for the front of the dossier.
• Draw the process. Present the whole chain from medical order, imaging, design and verification through to delivery as a flow diagram, marking the record produced at each step.
• Prepare overlapping products on two tracks. Where a product also contains an algorithm, prepare separate volumes against TR-008 and TR-009 rather than combining them in one narrative.
• Bring traceability records into the quality system. Confirm that quality management system documents cover the traceability requirements for personalised devices and that the scope matches the scope of the quality system certificate.

5. Verification checklist

• □ Whether the product meets the TR-009 definition of a personalised medical device has been confirmed
• □ The patient-matching process and the source of design inputs are described
• □ Verification and traceability records are prepared
• □ Whether TR-008 applies concurrently has been assessed
• □ The quality system certificate scope covers the design and manufacture of personalised devices
• □ The latest version and publication date of TR-009 have been confirmed

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