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MDD · East Asia & Pacific

Hong Kong medical device regulatory resources

Every Hong Kong dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.

8,472 listing records11 free resources24/25 requirements covered16 regulations trackedAug 2026 fees reviewed
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Everything we track for Hong Kong

Medical device registration database

Search official MDD device registration records.

Medical device registry insights

Explore market trends, registrations, manufacturers, and local representatives.

Medical device regulations

Browse official MDD regulations and guidance documents.

Registration timeline

Compare official and realistic approval times by device class and pathway.

Government registration fees

Review current MDD application, review, and renewal fees.

AI registration cost and timeline planner

Estimate the likely MDD pathway, government fees, dossier preparation time, review timeline, and registration steps.

Medical device regulation news

Follow recent MDD policy, guidance, and compliance updates.

AI medical device classifier

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Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Hong Kong requirements.

AI similar registered product finder

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Regulatory requirements data

Browse source-linked lifecycle, language, local-role, renewal, and change-control facts.

Structured regulatory requirements

Explore all 53 source-linked facts →

24 of 25 research dimensions currently covered · 18 official sources · latest verification 2026-09-07

Market entry

D01

Authority & regime

Verified
Competent authority
The Medical Device Division (MDD) of the Department of Health manages the Medical Device Administrative Control System (MDACS).
Voluntary listing regime
Listing under MDACS is voluntary; there is no statutory requirement to list a medical device before placing it on the Hong Kong market.
2 source-linked facts
Checked 2026-08-25
Open details →
D02

Legal basis & guidance

Verified
No device-specific ordinance
No Hong Kong ordinance specifically regulates the manufacture, import, distribution, supply and use of medical devices; the voluntary MDACS guidance framework applies instead.
Statutory framework in development
A statutory medical device control framework is under development by the Government; until enacted, requirements are set out in non statutory MDD documents (Guidance Notes GN 00 to GN 10, T…
2 source-linked facts
Checked 2026-08-25
Open details →
D03

Device definition & scope

Verified
Medical device definition includes software
The MDACS definition of medical device expressly includes software and reagents for in vitro use; IVD medical devices are separately defined (GN 00 clause 2.29).
Accessories follow the device rules
An accessory to a medical device is subject to the same regulations that apply to the medical device itself; devices for animals are outside scope.
4 source-linked facts
Checked 2026-08-25
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D05

Registration pathways

Verified
Market-access route (voluntary listing)
The current market access surface is the voluntary MDACS listing: traders and Class II/III/IV general medical devices and Class B/C/D IVD medical devices may be listed; Class I GMD and Clas…
Two listing pathways
Listing applications follow Pathway 1 (conformity assessment by a recognised Conformity Assessment Body leading to a Conformity Assessment Certificate) or Pathway 2 (marketing approval docu…
4 source-linked facts
Checked 2026-08-25
Open details →
D06

Reliance & recognition

Verified
Recognised jurisdictions for marketing approvals
Pathway 2 accepts marketing approval documents from eight recognised jurisdictions (Chinese Mainland NMPA, USA FDA, EU, Canada, Japan, Singapore, South Korea MFDS, Australia TGA); for examp…
EU MDD certificates accepted with extension declaration
For EU approvals, MDACS accepts EU MDR certificates with Declaration of Conformity, or EU MDD certificates accompanied by an MDD extension declaration letter signed as per Regulation (EU) 2…
2 source-linked facts
Checked 2026-08-25
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D07

Economic-operator roles

Verified
LRP transfer via takeover application
Transfer of LRP of a listed medical device is regarded as a Major Change; the party taking over submits a Takeover Application in MDIS (New, Change, Renew, Delist and Takeover application t…
Applicant and LRP eligibility
The listing applicant must be a local manufacturer or a Local Responsible Person (LRP) designated by the manufacturer; the LRP must be a legal person incorporated in Hong Kong, or a natural…
3 source-linked facts
Checked 2026-08-25
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D08

Establishment, import & distribution

Verified
Voluntary trader listing categories
Importers and local manufacturers of medical devices may apply to become Listed Importers or Listed Local Manufacturers under MDACS; distributors may be listed under GN 09. Trader listing i…
Listed importer record retention
A listed importer must retain records for not less than the projected service life of the device as defined by the manufacturer, or seven (7) years after the date the device is supplied to…
3 source-linked facts
Checked 2026-08-25
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D09

Dossier requirements

Verified
Core listing dossier
Core documents: manufacturer's letter designating the LRP; valid Hong Kong Business Registration Certificate; CAB Conformity Assessment Certificate (Pathway 1) or marketing approval documen…
Dossier language and translation evidence
All documents must be submitted in Simplified Chinese, Traditional Chinese or English; other language documents need an English or Chinese translation, with both original and translation su…
3 source-linked facts
Checked 2026-08-25
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D10

Official forms & portals

Verified
MDIS portal and application forms
Listing applications must be made electronically through the Medical Device Information System (MDIS) using application form MD101 or MD102; New, Change, Renew, Delist and Takeover applicat…
Adverse event report form AIR-LRP
LRPs must report Hong Kong adverse events using the Medical Device Adverse Event Report Form, Form Eng AIR LRP (GN 03 Appendix 3), also available on the MDD website.
2 source-linked facts
Checked 2026-08-25
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Submission & evidence

D11

Label, IFU & language

Verified
Bilingual labelling and IFU
Manufacturer and LRP contact details on labels must be in both English and Chinese wherever applicable; instructions for use (e.g. user manuals) must be in both Chinese and English, and if…
Special Listing Information and grace period
Listed devices must carry Special Listing Information: the device's Listing Number plus a supplementary statement if the IFU is available in only one language, and LRP name/address/contact…
2 source-linked facts
Checked 2026-08-25
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D12

QMS, audit & inspection

Verified
Acceptable QMS certificates
Acceptable manufacturer QMS evidence includes: ISO 13485 (or identical national/regional adoption) from a certification body accredited by a GACI (previously IAF) member signatory; GB/T 420…
MDD inspection of LRP records
The MDD may inspect originals or certified copies of records held by the LRP; the LRP must produce them within two weeks after receiving the notice.
2 source-linked facts
Checked 2026-08-25
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D13

Standards, testing & ancillary approvals

Unresolved
Medical electrical evidence
Electrical safety
OFCA technical compliance
Wireless / radio
OFCA voluntary certification/label
Wireless / radio
5 maintained overlays
Checked 2026-09-07
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D15

Review clocks

Verified
Class II · MDACS listing (Form MD101 via MDIS)
12 weeks
Class III · MDACS listing (Form MD101 via MDIS)
12 weeks
Class IV · MDACS listing (Form MD101 via MDIS)
12 weeks
3 maintained pathways · 1 related fact
Checked 2026-08-30
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D16

Approval validity & renewal

Verified
Listing validity 5 years
An approval or conditional approval for listing a device is valid for five (5) years.
Expiry consequence: new application required
Renewal applications are not accepted outside the 12 weeks to 1 year window, and if the listing has expired the applicant must submit a NEW application (not a renewal); unnotified or unappr…
3 source-linked facts
Checked 2026-08-25
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Lifecycle & post-market

D17

Change control

Verified
Change-control outcomes
Major Changes (changes that could be expected to affect safety, quality or performance) require MDD approval via a Change Application before implementation; Minor Changes may be implemented…
New-application triggers
MDD has discretion to require a new listing application based on the information submitted in a Change Application; for change of the manufacturer's name the LRP must submit a new listing a…
4 source-linked facts
Checked 2026-08-25
Open details →
D18

UDI, listing & traceability

Verified
LRP supply records retention
The LRP must keep supply records enabling tracing of devices imported and supplied in Hong Kong, retained for not less than the lifetime of the device as defined by the manufacturer, or sev…
Patient-level tracking for high-risk devices
The LRP must operate a tracking system that tracks high risk devices specified in GN 01 Appendix 1 down to patient level; where patient level tracking is not possible, tracking to user faci…
2 source-linked facts
Checked 2026-08-25
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D19

Clinical investigation & performance

Verified
Clinical evaluation report required
Clinical evaluation following defined processes (identify Essential Principles needing clinical data, identify/appraise/generate clinical data, draw conclusions) must be documented in a cli…
No local clinical trial legislation
There is currently no specific Hong Kong legislation regulating clinical trials of medical devices; local clinical study data is not a standing requirement for MDACS listing.
2 source-linked facts
Checked 2026-08-25
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D20

Special access & derogation

Verified
GBA urgent clinical use measure
Under the Greater Bay Area measure, designated healthcare institutions in the GBA may use, subject to Guangdong Province approval, Hong Kong registered drugs and medical devices used in Hon…
1 source-linked fact
Checked 2026-08-25
Open details →
D21

Manufacturer PMS

Verified
Conditional approval with PMS conditions
Applications may be approved, conditionally approved or rejected; conditional approval can impose conditions such as annual submission of post market surveillance reports, and non complianc…
Annual surveillance reports for Appendix 1 devices
For device categories listed in GN 01 Appendix 1, the LRP must submit surveillance reports (local, overseas or both) to MDD at least once a year; MDD may revise the schedule.
2 source-linked facts
Checked 2026-08-25
Open details →
D22

Vigilance & incident reporting

Verified
Reportable adverse event criteria
An adverse event is reportable to MDD when all three basic criteria are met: the LRP becomes aware of an event that occurred with its listed device(s); the device may be associated with the…
48-hour deadline for public-health-risk events
Adverse events that have posed or are likely to pose a public health risk must be reported by the LRP to MDD within 48 hours.
4 source-linked facts
Checked 2026-08-25
Open details →
D23

Recall, FSCA & market surveillance

Verified
Recall/FSN notification within 10 days
Upon issuance of product recalls or field safety notices by the manufacturer or overseas authorities, the LRP must inform MDD of details and Hong Kong actions as soon as possible and not la…
1 source-linked fact
Checked 2026-08-25
Open details →
D24

Advertising, claims & promotion

Verified
Advertising law compliance and MDACS reference restrictions
Advertisements and commercial promotional materials must not contravene the Undesirable Medical Advertisement Ordinance (Cap. 231); MDD disapproves references to MDACS in advertisements exc…
1 source-linked fact
Checked 2026-08-25
Open details →
D25

Submission communications & appeal

Verified
Appeal within 14 working days
The LRP may appeal against rejection, conditions imposed on a conditional approval, or removal from the List of Medical Devices within fourteen (14) working days of notification; late appea…
Appeal outcome: 4 weeks, final, no suspension
The LRP is notified of the appeal outcome within four (4) weeks of submission of the appeal and all required supporting information; the Appeal Committee decision is final; lodging an appea…
2 source-linked facts
Checked 2026-08-25
Open details →

Government fees

Full fee schedule (1 lines) →

MDD registration fees in HKD · reviewed 2026-08-25

Fee lineAmountProvenance
MDACS device-listing applicationHKD 0Verified

Registration timeline

Full registration timeline →

Medical Device Division (MDD) review clocks and planning ranges · 4-class (I, II, III, IV) classification

Class / pathwayReview clockPlanning totalProvenance
Class II(MDACS listing (Form MD101 via MDIS))12 weeks3-4 monthsVerified
Class III(MDACS listing (Form MD101 via MDIS))12 weeks3-5 monthsVerified
Class IV(MDACS listing (Form MD101 via MDIS))12 weeks3-6 monthsVerified
  1. 1Pre-Submission Preparation(1-3 months)
  2. 2Application Submission(1-2 weeks)
  3. 3Administrative Review(2-4 weeks)
  4. 4Technical Evaluation(12 weeks)
  5. 5Registration Approval(1-2 weeks)

Latest regulation news

All Hong Kong regulation news →

Newest official MDD headlines from the daily-refreshed feed — every row links directly to the authority publication.

Sep 1DODepartment of Health Medical Device DivisionHong Kong MDD Updates Guidance Notes (GN-01, GN-04, GN-07, GN-08, GN-09) and Associated Codes of Practice under MDACSHong KongJul 31DODepartment of Health Medical Device DivisionUpdated Guidance Notes for Listing Medical Devices and IVDs in Hong KongHong KongJun 26DODepartment of Health Medical Device DivisionUpdated Guidance Notes for Changes of Listed Medical Devices (GN-10) under MDACSHong KongJun 12DODepartment of Health Medical Device DivisionRevamp of Medical Device Listing Application Forms (MD101 and MD102) under MDACSHong Kong

Key regulations

All 16 Hong Kong regulations →

Official MDD rules and guidance · 16 of 16 documents linked to official sources

MDD HomeMedical Device Division - Department of Health
GeneralVerified
MDACS ListingMedical Device Administrative Control System - Listing Application
RegistrationVerified
Issued DocumentsIssued Documents under MDACS
GeneralVerified
Guidance NotesGuidance Notes for Medical Devices
GeneralVerified

Registry insights

Full registry statistics →

Computed from 8,472 official MDD listing records · data as of 2024-10-16

New listings by year
2018201920202021202220232024
VerifiedMDD registry · as of 2024-10-16
5,000
Active listings
1,260
Manufacturers
336
Local Responsible Persons
30
Origin countries
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Hong Kong market-launch workpaper

Connect the MDD route, evidence, labels, local role, timing, and dependencies to a wider launch plan.

Hong Kong dossier reuse and delta

Compare an existing authorization and evidence set against MDD administrative, testing, labeling, and dossier needs.

Hong Kong change notification workpaper

Map a product or manufacturing change to MDD evidence, notification, timing, and implementation questions.

Hong Kong regulatory change impact

Assess a current MDD update against one product and turn it into an owner-ready action workpaper.

Hong Kong cybersecurity evidence review

Review connected-device architecture, risks, SBOM, testing, lifecycle controls, and market-specific questions for Hong Kong (MDD).

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