MDD market accessResearch MDD registration records, classification, regulations, timelines, fees, and market updates — the stable entrance to every Hong Kong medical device resource.
Search official MDD device registration records.
Explore market trends, registrations, manufacturers, and local representatives.
Browse official MDD regulations and guidance documents.
Compare official and realistic approval times by device class and pathway.
Review current MDD application, review, and renewal fees.
Estimate the likely MDD pathway, government fees, dossier preparation time, review timeline, and registration steps.
Follow recent MDD policy, guidance, and compliance updates.
Describe your device and get a preliminary MDD risk class with an explanation and source links.
Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Hong Kong requirements.
Describe a device and find comparable products in the MDD registration database.
Browse source-linked lifecycle, language, local-role, renewal, and change-control facts.
Common questions about changing a registered medical device in Hong Kong. Each question separates published rules from details still awaiting verification.
24 of 25 research dimensions currently covered · 19 official sources · latest verification 2026-09-15
MDD registration fees in HKD · reviewed 2026-08-25
| Fee line | Amount | Provenance |
|---|---|---|
| MDACS device-listing application | HKD 0 | Verified |
Medical Device Division (MDD) review clocks and planning ranges · 4-class (I, II, III, IV) classification
| Class / pathway | Review clock | Planning total | Provenance |
|---|---|---|---|
| Class II(MDACS listing (Form MD101 via MDIS)) GN-02 clause 5.3.1: vetting and approval should normally be completed within 12 weeks, counted from submission of the application and all required supporting information — including anything requested mid-assessment, so a question resets the practical start Acknowledgement of receipt goes to the registered email; GN-02 clause 5.2.1 tells applicants to chase MDD only if nothing arrives within 2 weeks Failure to supply requested supporting information within the stipulated timeframe closes the application outright rather than pausing it Appeals against rejection, conditional-approval conditions or delisting go to the Medical Device Administration Appeal Committee within 14 working days, and the outcome is notified within 4 weeks of a complete appeal (GN-02 clauses 6.1 and 6.5) | 12 weeks | 3-4 months | Verified |
| Class III(MDACS listing (Form MD101 via MDIS)) Same 12-week GN-02 clause 5.3.1 clock as Class II and Class IV — MDD does not band the listing period by risk class The applicant either holds an MDACS Conformity Assessment Certificate from an MDD-recognised body (D001) or submits marketing approvals from the named reference jurisdictions (D002); one or the other is mandatory Where an MDSAP certificate is used as the QMS evidence, it must be paired with a marketing approval from a jurisdiction that itself recognises MDSAP | 12 weeks | 3-5 months | Verified |
| Class IV(MDACS listing (Form MD101 via MDIS)) Same 12-week GN-02 clause 5.3.1 clock; Class IV was the first class MDACS opened to listing when the system was phased in from 2004 Approval may be conditional — commonly on annual post-market surveillance reports — and breaching a condition can lead to delisting | 12 weeks | 3-6 months | Verified |
Newest official MDD headlines from the daily-refreshed feed — every row links directly to the authority publication.
Hong KongOct 29DODepartment of Health Medical Device DivisionHong Kong Medical Device Division Updates List of Recognised Standards (RS-01)Hong KongSep 18DODepartment of Health Medical Device DivisionDepartment of Health Delegates Attend Roundtable on Medical AI Regulation and Guidance in Hong KongHong KongSep 15DODepartment of Health Medical Device DivisionDH and NMPA Co-organize Seminar on GBA Medical Device Regulations and Registration Process TrainingHong KongSep 8DODepartment of Health Medical Device DivisionGuidance Notes 'Overview of the Medical Device Administrative Control System' (GN-01) UpdatedHong KongOfficial MDD rules and guidance · 16 of 16 documents linked to official sources
Computed from 8,472 official MDD listing records · data as of 2024-10-16
The target market is carried into each tool. Add the product, evidence, or regulatory change you want to assess.
Structure company, product, model, approval, certificate, and evidence facts before starting Hong Kong work.
Connect the MDD route, evidence, labels, local role, timing, and dependencies to a wider launch plan.
Compare an existing authorization and evidence set against MDD administrative, testing, labeling, and dossier needs.
Map a product or manufacturing change to MDD evidence, notification, timing, and implementation questions.
Assess a current MDD update against one product and turn it into an owner-ready action workpaper.
Review connected-device architecture, risks, SBOM, testing, lifecycle controls, and market-specific questions for Hong Kong (MDD).
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