Hong Kong MDACS Reference Country Pathway: Accepted Marketing Approvals and GN-06 Requirements

Quick answer

Which marketing approvals does Hong Kong MDACS accept as reference countries?

Hong Kong's Medical Device Administrative Control System (MDACS), administered by the Medical Device Division (MDD) of the Department of Health, offers Pathway 2 listing for Class II–IV general medical devices (GMD) and Class B–D in vitro diagnostic medical devices (IVDMD). Under Pathway 2, applicants submit reference marketing approval documents from eight recognised jurisdictions instead of a Conformity Assessment Body (CAB) certificate: China (NMPA), the United States (FDA), European Union member states, Canada (Health Canada), Japan (MHLW), Australia (TGA), South Korea (MFDS), and Singapore (HSA). From 1 January 2024, MDD accepts NMPA and MFDS approvals on a regular basis. Specific documents per jurisdiction are listed in Section D002 of Guidance Note GN-02 (GMD) or GN-06 (IVDMD). Applications are filed electronically through MDIS (Medical Device Information System) by a Local Responsible Person (LRP). Typical review is 12 weeks; listing certificates are valid 5 years and free of charge.

Who this applies to

This guide applies to:

• Overseas manufacturers seeking voluntary MDACS listing for Hong Kong market access
• Local Responsible Persons (LRPs) designated to submit listing applications on behalf of manufacturers
• Regulatory affairs teams mapping reference-market approvals (FDA 510(k), EU MDR/IVDR, NMPA registration, TGA ARTG, etc.) to Hong Kong dossier requirements
• IVD and general device sponsors listing Class II, III, or IV GMD or Class B, C, or D IVDMD — the product classes eligible for full MDACS listing review

Pathway 2 does not apply to Class I GMD or Class A IVDMD, which fall outside the standard listing scope described in MDD's overview. Class I/A devices may follow other MDACS routes where applicable. If you hold a CAB Conformity Assessment Certificate, use Pathway 1 (Section D001) instead.

Pathway 1 (CAB) vs Pathway 2 (reference approvals)

MDACS listing applications must demonstrate conformity with Essential Principles of Safety and Performance (Technical Reference TR-004 for GMD; TR-005 for IVDMD). MDD offers two parallel evidence routes:

You select the applicable route in D001/D002 of form MD101 (GMD) or MD102 (IVDMD). Where a CAB certificate is available, submit it in D001. Where no CAB certificate exists, submit reference marketing approval documents in D002. Both pathways still require the full technical dossier: clinical or performance evaluation, labelling, Essential Principles checklist, and QMS certificate.

Recognised reference jurisdictions (2024 update)

MDD's Overview of Hong Kong Medical Device Listing Process (September 2025) lists the following recognised jurisdictions for Pathway 2:

On 1 January 2024, MDD published an MDACS Activities announcement confirming that marketing approvals from NMPA and MFDS are accepted on a regular basis as support for compliance with TR-004 Essential Principles. MDD simultaneously updated GN-01, GN-02, GN-06, and application forms MD101 and MD102 to reflect the expanded jurisdiction list.

Important: Acceptance of NMPA or MFDS approvals does not replace the full MDACS dossier. Pathway 2 uses reference approvals as conformity evidence in D002; you must still submit performance or clinical evaluation, labelling per TR-005, QMS certificates, and other Part C documentation.

GN-02 vs GN-06: which guidance note applies?

Both GN-02 and GN-06 contain a D002 section with jurisdiction-specific document requirements. The EU transition rules differ between GMD and IVDMD (see jurisdiction matrix below). Classification rules are set out in TR-003 (GMD) and TR-006 (IVDMD). Confirm your device class before selecting the form — submitting under the wrong GN delays review.

GN-02:2026(E) and GN-06:2026(E) are the current editions on mdd.gov.hk. Check MDD's website for the latest revision before filing; GN-06 was updated multiple times in 2024 (including 2 April and 14 June revisions to accepted marketing approvals scope).

D002 jurisdiction document matrix

Section D002 of MD101/MD102 requires you to select applicable jurisdiction checkboxes and upload the corresponding approval documents. Certificate number, issue date, and expiry date must be entered where applicable. All product model(s) and product code(s) must be explicitly specified in the marketing approval certificate(s) and supporting documents submitted.

General medical devices (GN-02 / MD101)

In vitro diagnostic medical devices (GN-06 / MD102)

MDD may request a valid Certificate of Free Sale at its discretion for any jurisdiction. Submit all relevant certificates to facilitate assessment.

QMS certificates linked to D002

GN-02 and GN-06 tie certain QMS options to D002 submissions:

Manufacturer name and address in the application must match the D002 certificate(s), the LRP designation letter, and device labelling.

Model and product code alignment rules

MDD assesses listing scope against the reference approval documents. Critical alignment requirements from GN-02/GN-06 D002:

1. Every model and product code in the Hong Kong application must appear explicitly on the reference marketing approval certificate or its supporting documents (e.g., NMPA Product Technical Requirements, TGA DoC).
2. Manufacturer identity on D002 certificates must match Part B manufacturer details and labelling.
3. Device description in Part C must be consistent with the approved intended use in the reference jurisdiction.
4. If a model is not covered by the reference approval, either obtain an amended approval covering that model or use Pathway 1 (CAB assessment) instead.
5. For EU submissions, ensure MDR/IVDR (or legacy MDD/IVDD with valid extension) certificates cover the exact device scope — including any variant or software version for SaMD.

Mismatch between HK listing scope and D002 certificate scope is one of the most common causes of MDD supplementary information requests and application closure.

MDIS submission workflow

All MDACS listing applications are submitted electronically through the Medical Device Information System (MDIS) on mdd.gov.hk.

Step-by-step Pathway 2 workflow:

1. Confirm eligibility — Class II–IV GMD or Class B–D IVDMD; appoint an LRP incorporated or registered in Hong Kong.
2. Classify the device — Apply TR-003 (GMD) or TR-006 (IVDMD); document rationale in Part C.
3. Select GN and form — GN-02 + MD101 for GMD; GN-06 + MD102 for IVDMD.
4. Gather D002 documents — Collect jurisdiction-specific approvals per matrix above; verify model/code coverage.
5. Prepare remaining dossier — QMS certificate (ISO 13485 or linked alternative), Essential Principles checklist (MD-CCL or MDIVD-CCL, or EU ER/GSPR if applicable), clinical evaluation report (GMD) or performance evaluation report (IVDMD), labelling per TR-005, LRP designation letter, Hong Kong Business Registration Certificate.
6. Open MDIS account — First-time applicants register on MDIS; keep account profile current (LRP address and BR details sync from profile).
7. Complete MD101/MD102 online — Select D002 jurisdiction checkboxes; upload documents; enter certificate numbers and dates.
8. Submit via MDIS — Electronic submission only; no paper dossier.
9. Respond to supplementary requests — MDD may request additional information on MDIS within specified deadlines; insufficient responses lead to application closure.
10. Receive listing certificate — Typical review 12 weeks from complete submission; certificate valid 5 years; renewal at least 12 weeks before expiry.

Listing fees are free of charge under the current MDACS framework. Budget internal resources for dossier preparation, translation (documents not in English or Chinese require certified translation per GN-06 Section 8.3), and LRP post-market obligations.

Essential Principles checklist alternatives

Beyond D002, Part D requires an Essential Principles conformity checklist:

The EU checklist shortcut applies only when valid EU marketing approval certificates are submitted in D002.

Checklist

• Device classified under TR-003 (GMD) or TR-006 (IVDMD) as Class II–IV or B–D
• LRP appointed — legal person in Hong Kong or registered business with valid BR certificate
• Correct form selected: MD101 (GN-02) or MD102 (GN-06)
• D002 jurisdiction checkbox(es) selected with complete approval documents
• All models and product codes explicitly listed on reference approval certificate(s)
• NMPA: registration certificate + Product Technical Requirements (if using China reference)
• MFDS: Certificate of Free Sale (if using Korea reference, from 1 Jan 2024)
• FDA: 510(k), PMA, or De Novo letter; CFG ready if requested
• EU: MDR/IVDR or legacy MDD/IVDD with valid extension declaration + DoC
• QMS certificate submitted (ISO 13485 or linked GB/T 42061 / MDSAP / KGMP with D002 cross-reference)
• MD-CCL or MDIVD-CCL completed (or EU ER/GSPR with EU D002)
• Clinical/performance evaluation report prepared
• Labelling and IFU comply with TR-005 (including HKMD listing number placeholder)
• MDIS account active; LRP profile details current
• Documents in English, Traditional Chinese, or Simplified Chinese — certified translation for other languages
• Renewal calendar set for 5-year certificate; submit renewal ≥12 weeks before expiry

Common pitfalls

1. Submitting NMPA or MFDS approvals before 1 January 2024 without checking revision — Pre-2024 GN editions did not include these jurisdictions; ensure you use GN-02/GN-06 editions updated from January 2024 onward.
2. Missing Product Technical Requirements for NMPA — The registration certificate alone is insufficient; D002 requires both the 注册证 and 產品技術要求.
3. Model gaps on reference certificate — Adding HK models not covered by the FDA 510(k) or NMPA approval triggers rejection or supplementary cycles.
4. Wrong GN form — IVDMD submitted on MD101/GN-02 instead of MD102/GN-06 (or vice versa) delays processing.
5. Expired EU MDD/IVDD without extension letter — Legacy certificates need the Regulation (EU) 2023/607 (MDD) or 2024/1860 (IVDD) extension declaration; MDR/IVDR certificates are preferred.
6. KGMP or GB/T 42061 without linked D002 approval — QMS options tied to NMPA/MFDS require corresponding D002 marketing approval documents.
7. Stale MDIS account profile — LRP address and BR details must match submission; update profile before filing.
8. Missing translation — Non-English/Chinese documents without certified translation cause MDIS rejection under GN-06 Section 8.3.

FAQ

Which reference countries does Hong Kong MDACS accept?

MDACS Pathway 2 accepts marketing approvals from eight jurisdictions: Chinese Mainland (NMPA), United States (FDA), European Union member states, Canada (Health Canada), Japan (MHLW), Australia (TGA), South Korea (MFDS), and Singapore (HSA). NMPA and MFDS were added to regular acceptance from 1 January 2024.

What is MDACS Pathway 2?

Pathway 2 is the MDACS listing route where applicants submit reference marketing approval documents (Section D002 of MD101/MD102) from recognised jurisdictions instead of an MDACS Conformity Assessment Body certificate (Pathway 1, Section D001). It applies to Class II–IV GMD and Class B–D IVDMD listing applications filed through MDIS by an LRP.

When did Hong Kong start accepting NMPA and MFDS approvals?

From 1 January 2024, MDD announced regular acceptance of marketing approvals from NMPA (Chinese Mainland) and MFDS (South Korea) as support for Essential Principles compliance under TR-004. Updated GN-01, GN-02, GN-06, MD101, and MD102 were published on mdd.gov.hk the same day.

What FDA documents are required for HK listing Pathway 2?

For US reference approvals, D002 requires 510(k) (Premarket Notification), PMA (Premarket Approval), or De Novo clearance/approval from FDA. MDD may request a Certificate to Foreign Government (CFG) upon request. All models in the HK application must appear on the FDA approval document.

What is the difference between GN-02 and GN-06?

GN-02 governs listing of Class II, III, and IV general medical devices using form MD101. GN-06 governs listing of Class B, C, and D in vitro diagnostic medical devices using form MD102. Both contain D002 reference jurisdiction requirements, but EU transition document rules differ (MDR/MDD for GMD vs IVDR/IVDD for IVDMD).

Must all models appear on the reference approval certificate?

Yes. GN-02 and GN-06 D002 explicitly require that all product model(s) and product code(s) shall be explicitly specified in the marketing approval certificate(s) and supporting documents submitted. Models not covered by the reference approval cannot be listed under Pathway 2 for those models.

Official sources

• Medical Device Division (MDD), Department of Health — Overview of Hong Kong Medical Device Listing Process (PDF)
• MDD — GN-02: Guidance Notes for Listing Class II/III/IV General Medical Devices (PDF)
• MDD — GN-06: Guidance Notes for Listing Class B/C/D In Vitro Diagnostic Medical Devices (PDF)
• MDD — MDACS Activities: NMPA and MFDS acceptance from 1 January 2024
• MDD — MDACS home