Hong Kong TR-005 Medical Device Labelling Checklist (MDACS)

Quick answer

TR-005 (Additional Medical Device Labelling Requirements) is Hong Kong MDACS guidance on labelling principles and content for medical devices within MDACS scope. The Local Responsible Person (LRP) must ensure labelling meets Clause 4 requirements before and after listing. Labelling must communicate information needed for safe use, performance, and device identification, and is submitted as part of Class II/III/IV general device and Class B/C/D IVD listing applications under GN-02 and GN-06.

Who this applies to

• Local Responsible Persons (LRPs) for MDACS-listed devices
• Manufacturers preparing Hong Kong listing dossiers
• Regulatory teams handling GN-02 (general medical devices) and GN-06 (IVD) applications
• Importers placing listed devices on the Hong Kong market

Scope: products within MDACS scope per TR-005 Clause 2.1 — do not apply TR-005 blindly to products outside MDACS.

LRP labelling responsibilities (TR-005 Clause 1.1)

The LRP must ensure labelling requirements in Clause 4 are met for devices listed under MDACS. This is an ongoing obligation — not only at initial listing.

Core labelling principles (TR-005 Clause 4)

Labelling should provide information necessary for:

• Safe use of the device
• Performance expectations appropriate to the device
• Identification of the device, manufacturer, and supply chain context

TR-005 Clause 4.1 and 4.2 establish general principles for label content and presentation. Review the official TR-005 PDF for device-specific label elements applicable to your product type.

Labelling in listing applications

GN-02 and GN-06 require labelling and special listing information as part of listing submissions:

• GN-02 — Guidance Notes for Listing Class II/III/IV General Medical Devices
• GN-06 — Guidance Notes for Listing Class B/C/D IVD Medical Devices

Prepare label artwork, IFU drafts, and language versions consistent with application requirements before submission.

TR-005 labelling checklist

Device identification

• Device name/trade name on label
• Model/catalogue number
• Lot/batch or serial number (as applicable)
• UDI or identification scheme where applicable

Manufacturer and LRP information

• Manufacturer name and address
• LRP name and Hong Kong contact details on label where required
• Country of manufacture where required

Safe use information

• Intended purpose/indications consistent with listing
• Warnings and precautions on label or IFU as required
• Storage/handling conditions if applicable
• Sterility status and expiry date (if sterile/ time-sensitive)

Language requirements

• English and Chinese labelling expectations met per listing context
• IFU language requirements aligned with GN-02/GN-06 and TR-005
• Consistency between outer label, inner label, and IFU

Listing consistency

• Label claims match MDACS listing scope
• No off-label claims beyond approved listing
• Special listing information matches GN-02/GN-06 templates

Step-by-step labelling workflow

1. Confirm device is within MDACS scope (TR-005 Clause 2.1).
2. Assign LRP responsibility for Clause 4 compliance.
3. Extract label elements from TR-005 Clause 4 for your device category.
4. Cross-check GN-02 or GN-06 labelling submission sections.
5. Prepare English/Chinese label and IFU drafts.
6. Run internal checklist against TR-005 before listing submission.
7. After listing approval, control label changes through MDACS change procedures.

Common pitfalls

1. Treating TR-005 as optional branding guidance — it defines MDACS labelling obligations.
2. LRP not reviewing Clause 4 — LRP is explicitly responsible per Clause 1.1.
3. Mismatch between listing dossier and market label — GN-02/GN-06 submissions must align with shipped labels.
4. Missing Chinese language elements where listing requires bilingual materials.
5. Applying TR-005 outside MDACS scope without regulatory justification.

FAQ

What is TR-005 in Hong Kong MDACS?

Official MDD guidance on additional medical device labelling requirements under MDACS.

Who is responsible for TR-005 compliance?

The Local Responsible Person (LRP) must ensure Clause 4 requirements are met.

Does TR-005 apply to all medical products in Hong Kong?

It applies to products within MDACS scope (Clause 2.1).

Where are labelling files submitted?

As part of GN-02 (general devices) or GN-06 (IVD) listing applications, plus ongoing LRP obligations post-listing.

Are English and Chinese both required?

Official listing materials and TR-005/GN guidance define language expectations — verify against your device listing class and application type.

Official sources

• TR-005 English PDF: https://www.mdd.gov.hk/filemanager/common/mdacs/TR005E.pdf
• TR-005 Chinese PDF: https://www.mdd.gov.hk/filemanager/common/mdacs/TR005C.pdf
• GN-02 English PDF: https://www.mdd.gov.hk/filemanager/common/mdacs/GN-02-E.pdf
• GN-06 English PDF: https://www.mdd.gov.hk/filemanager/common/mdacs/GN-06-E.pdf