MDD · structured requirements

🇭🇰 Hong Kong medical device regulatory data

Explore the medical device requirements currently available for Hong Kong, organized by topic and linked to official sources.

55 facts23 dimensions12 official sourceslatest verification 2026-09-15

Advertising, claims & promotion

Which claims, audiences, channels, approvals, and restrictions apply?

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Advertising law compliance and MDACS reference restrictions

ads.cap231-compliance-and-delisting

Fact-level verified

Advertisements and commercial promotional materials must not contravene the Undesirable Medical Advertisement Ordinance (Cap. 231); MDD disapproves references to MDACS in advertisements except permitted exceptions (no claim of Government endorsement); an unjustified claim not withdrawn per DH instruction (which may require newspaper statements in at least four Chinese and one English newspaper) leads to delisting.

Conditions

Applies to LRP/manufacturer advertising of listed devices.

Cap. 231 itself on elegislation.gov.hk could not be opened directly from this environment; rule verified via official MDD guidance text.

Approval validity & renewal

What expires, what is retained periodically, and when must renewal start?

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Listing validity 5 years

authorization.duration

Fact-level verified

An approval or conditional approval for listing a device is valid for five (5) years.

Conditions

Applies to MDACS listings (voluntary system).

Overview PDF confirms 'Certificate validity: 5 years'.

Expiry consequence: new application required

authorization.lapse

Fact-level verified

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 unapproved changes also invalidate the listing immediately.

Conditions

Late renewal outside the window is not processed.

Corrects the baseline value: the stated consequence of missing the window/expiry is a new application rather than discretionary delisting.

Renewal window 12 weeks to 1 year before expiry

authorization.renewal

Fact-level verified

The LRP must submit the renewal application between 12 weeks and 1 year (inclusive) before expiry of the five-year validity; no renewal application is accepted outside this window.

Conditions

Applies to MDACS listings.

Clauses 5.15.1/5.15.2 revised 31 December in GN-01:2025-1(E).

Authority & regime

Which authority and binding regime govern this product, task, and date?

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Competent authority

authority.competent-authority

Fact-level verified

The Medical Device Division (MDD) of the Department of Health manages the Medical Device Administrative Control System (MDACS).

Conditions

Applies to all devices and traders within the voluntary MDACS.

MDACS = Medical Device Administrative Control System, voluntary since November 2004.

Voluntary listing regime

authority.regime-voluntary

Fact-level verified

Listing under MDACS is voluntary; there is no statutory requirement to list a medical device before placing it on the Hong Kong market.

Conditions

Applies to all device classes.
Department of Health procurement requires listing for applicable devices (Stage C, from 23 March 2026).

MDACS launched November 2004; it has the same scope as the proposed statutory framework.

Change control

Does the event require internal documentation, notice, prior approval, transfer, or a new application?

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Change-control outcomes

change.available-outcomes

Fact-level verified

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 before approval but must be notified.

Conditions

Major Change defined in GN-10 clause 2.1.
Some administrative changes need no reporting (GN-10 clause 5.3).

Overview PDF: 'Major changes require prior approval; minor changes require notification.'

Minor change notification within 24 weeks

change.minor-notification-24-weeks

Fact-level verified

For Minor Changes, the LRP may implement the change before approval but must notify MDD by submitting a Change Application within 24 weeks from becoming aware of the change.

Conditions

Applies to Minor Changes as defined in GN-10.

Distinct deadline rule introduced in GN-10:2026(E).

New-application triggers

change.new-application-triggers

Fact-level verified

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 application instead of a Change Application.

Conditions

Manufacturer name change mandatorily triggers a new application.

Confirms baseline; adds the mandatory manufacturer-name-change trigger.

Unnotified change invalidates listing

change.unnotified-invalidates-listing

Fact-level verified

The listing becomes invalid immediately if the device undergoes changes without notifying MDD within the specified timeframe or obtaining prior approval; a Major Change implemented without prior approval means the device is no longer regarded as listed.

Conditions

Applies to all listed devices.

A rejected change application followed by implementation has the same effect (GN-10 clause 7.6.2).

Clinical investigation & performance

Which clinical or IVD performance evidence or study is required and accepted?

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Clinical evaluation report required

evidence.clinical-evaluation-report

Fact-level verified

Clinical evaluation following defined processes (identify Essential Principles needing clinical data, identify/appraise/generate clinical data, draw conclusions) must be documented in a clinical evaluation report; the clinical evaluation plan may be requested to substantiate the methodology.

Conditions

Applies to Class II/III/IV GMD listing applications.
IVD listings require a performance evaluation report instead (GN-06).

Report may rely on manufacturer clinical studies and/or literature review with relevance evaluation.

No local clinical trial legislation

evidence.no-clinical-trial-legislation

Fact-level verified

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.

Conditions

Situation may change when the statutory framework is enacted.

Clinical evidence is assessed through the clinical evaluation report instead.

Device definition & scope

Is the product a device, IVD, accessory, software, or borderline product locally?

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Accessories follow the device rules

definition.accessory-same-rules

Fact-level verified

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.

Conditions

Applies where the parent device is within MDACS scope.

GN-00 defines Accessory (for IVD) separately; the general accessory rule is stated in the FAQ.

Medical device definition includes software

definition.medical-device-includes-software

Fact-level verified

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).

Conditions

Definition used across all MDACS guidance.

Definition revised 13 May 2026 in GN-00:2026-1(E).

Refurbished and custom-made devices excluded

scope.exclusions-refurbished-custommade

Fact-level verified

Refurbished medical devices (3.2.1.10) and custom-made medical devices (3.2.1.11) are outside MDACS scope; devices for non-clinical purposes such as Research Use Only are also excluded (3.2.1.12).

Conditions

Exclusions listed in GN-01 clause 3.2.1 alongside pharmaceuticals, blood/tissue products, PPE, cosmetics and others.

Clause 3.2.1.11 revised 9 May 2025 (GN-01:2025(E)).

Software and AI medical devices covered

scope.software-samd-aimd-covered

Fact-level verified

MDACS covers software embedded in medical devices (SiMD) and standalone software as a medical device (SaMD) per TR-007, and artificial intelligence medical devices (AI-MD) per TR-008.

Conditions

Applies to software meeting the medical device definition.

TR-007 describes SiMD/SaMD scope; GN-02 checklist item C009 captures SaMD/SiMD/AI-MD status.

Dossier requirements

Which evidence, local deltas, formats, and signatures are required?

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Core listing dossier

dossier.core-documents

Fact-level verified

Core documents: manufacturer's letter designating the LRP; valid Hong Kong Business Registration Certificate; CAB Conformity Assessment Certificate (Pathway 1) or marketing approval documents (Pathway 2); ISO 13485 certificate or equivalent; Essential Principles Conformity Checklist/Declaration; Clinical Evaluation Report (GMD) or Performance Evaluation Report (IVDMD); device labelling; and relevant Hong Kong licences (e.g. under Radiation Ordinance Cap. 303).

Conditions

Pathway-specific documents depend on chosen pathway.

Detailed checklist in GN-02 Appendix I (items A001-E003).

Dossier language and translation evidence

dossier.language-translation

Fact-level verified

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 submitted; translation accuracy must be demonstrated on request (e.g. ISO 17100 certification or notary public evidence).

Conditions

Applies to all submitted documents.

All versions and translations must be consistent with each other.

Statutory licence overlays in dossier

dossier.statutory-licences

Fact-level verified

Where applicable, copies of licences under the Radiation Ordinance (Cap 303), Pharmacy and Poisons Ordinance (Cap 138), Antibiotics Ordinance (Cap 137), Dangerous Drugs Ordinance (Cap 134) or Telecommunications Ordinance (Cap 106) must be submitted (e.g. Irradiating Apparatus Licence, Wholesale Dealer Licence).

Conditions

Only where the device falls under those ordinances.

These are the product-specific statutory overlays that exist in the absence of a device ordinance.

Economic-operator roles

Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?

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LRP transfer via takeover application

market-entry.representative-change

Fact-level verified

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 types all run through MDIS).

Conditions

The incoming LRP must satisfy LRP eligibility requirements.

Confirms baseline: MDIS expressly supports takeover, distinct from ordinary change and renewal.

Applicant and LRP eligibility

roles.applicant-lrp-eligibility

Fact-level verified

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 or legal person with business registration in Hong Kong.

Conditions

Applies to all device listing applications.

The duplicated word 'with with' appears verbatim in the official PDF.

LRP listing tied to device application

roles.lrp-listing-with-device-application

Fact-level verified

Application for inclusion on the List of LRPs must be made together with the device listing application; required documents include a valid Business Registration Certificate, the manufacturer's designation letter and a set of documented procedures.

Conditions

Applies to first-time LRP listing.

Documented procedures cover supply records, complaint handling, recalls, adverse events and tracking.

Establishment, import & distribution

Which establishment licences, importer permissions, and distribution controls apply?

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Listed importer record retention

establishment.importer-record-retention

Fact-level verified

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 another person, whichever is longer.

Conditions

Applies to listed importers under GN-07.

Mirrors the LRP supply-record retention rule in GN-01 clause 4.4.3.

Voluntary trader listing categories

establishment.trader-listing-voluntary

Fact-level verified

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 is voluntary like device listing.

Conditions

Separate from device listing; importers per GN-07, local manufacturers per GN-08, distributors per GN-09.

No import licence is required for medical devices as such; only product-specific ordinances may require licences.

DH procurement mandates listed devices

procurement.dh-stage-c-mandatory-listing

Fact-level verified

Since 23 March 2026 (Stage C enhanced measures), all applicable medical devices (Class II/III/IV GMDs and Class B/C/D IVDMDs) procured by the Department of Health must be listed under MDACS.

Conditions

Applies to DH procurement of applicable MDs.
Applicable MDs defined per MDACS classification rules.

Effective from 2026-03-23

Converts the voluntary listing into a de facto requirement for the public procurement channel; Hospital Authority procurement info is also in GN-02 E003.

Fees

What regulator fee applies to this class, route, event, and date?

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No government application fee

fees.no-application-fee

Fact-level verified

No fee is charged by the Government for inclusion of devices into the Lists of Medical Devices or for applications for such inclusion; applicants bear only third-party costs such as conformity assessment body certification charges.

Conditions

Applies to all device listing applications and trader listings under MDACS.

Distinct legal rule recorded as a fact in addition to the government-fees typed finding; official overview PDF likewise states 'Fee: Free of charge'.

Label, IFU & language

Which label and IFU elements, languages, symbols, and translation controls apply?

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Bilingual labelling and IFU

label.bilingual-requirements

Fact-level verified

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 only one language is available this must be stated per the Special Listing Information requirements; other labelling should preferably be bilingual and at least in one of the two languages.

Conditions

Applies to labels and IFU of listed devices.

TR-005:2021(E) is the current edition.

Special Listing Information and grace period

label.special-listing-info-grace

Fact-level verified

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 in English and Chinese; the LRP has a six-month grace period after listing to comply.

Conditions

Compliance via on-packaging display or a delivered document (GN-01 clause 4.4.13 Options I/II).

Listing numbers take the form HKMD No. xxxxxx.

Legal basis & guidance

Which current law, regulation, guidance, and transition provisions apply?

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No device-specific ordinance

legalbasis.no-specific-legislation

Fact-level verified

No Hong Kong ordinance specifically regulates the manufacture, import, distribution, supply and use of medical devices; the voluntary MDACS guidance framework applies instead.

Conditions

Depending on product nature, devices may fall under the Pharmacy and Poisons Ordinance (Cap 138), the Radiation Ordinance (Cap 303), or the Telecommunications Ordinance (Cap 106).

Verified as still current on the MDD FAQ page opened 2026-08-25.

Statutory framework in development

legalbasis.statutory-framework-pending

Fact-level verified

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, Technical References TR-003 to TR-008, Codes of Practice and the recognised standards list).

Conditions

Transitional situation; monitor for enactment.

FAQ states MDACS has the same scope as the proposed legislative control framework.

Manufacturer PMS

Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?

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Annual surveillance reports for Appendix 1 devices

pms.annual-surveillance-reports

Fact-level verified

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.

Conditions

Applies to high-risk device categories in GN-01 Appendix 1.

Applications must also disclose past recalls/AEs/bans and PMS studies (GN-02 checklist item C011).

Conditional approval with PMS conditions

pms.conditional-approval-conditions

Fact-level verified

Applications may be approved, conditionally approved or rejected; conditional approval can impose conditions such as annual submission of post-market surveillance reports, and non-compliance with a condition may result in delisting.

Conditions

Applies where MDD grants conditional approval.

GN-01 clause 5.10 gives the parallel rule for the LRP route.

Official forms & portals

Which current form, portal, account, and submission package must be used?

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Adverse event report form AIR-LRP

forms.air-lrp-adverse-event

Fact-level verified

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.

Conditions

Applies to adverse events that have taken place in Hong Kong.

Initial contact for urgent public-health-risk events via MDD Duty Officer.

MDIS portal and application forms

forms.mdis-md101-md102

Fact-level verified

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 applications all run via MDIS.

Conditions

First-time applicants must open an MDIS account.

MDIS portal: https://mdis.mdd.gov.hk/

QMS, audit & inspection

Which QMS, audit, inspection, and certificate scope is accepted or required?

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Acceptable QMS certificates

qms.acceptable-qms-certificates

Fact-level verified

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 42061 from a CNAS-recognised body; NMPA Manufacturing Licence; MDSAP certificate; or KGMP, with conditional pairings to the corresponding marketing approvals.

Conditions

Some certificates are only accepted when paired with the matching jurisdiction's approval (e.g. GB/T 42061 or NMPA licence with NMPA approval; MDSAP with an MDSAP-recognising jurisdiction; KGMP with MFDS licence).

Updated in GN-02:2026 edition.

MDD inspection of LRP records

qms.records-inspection

Fact-level verified

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.

Conditions

Applies to LRPs of listed devices.

Covers records the LRP claims to possess or has copied to MDD.

Recall, FSCA & market surveillance

Which recall, FSCA, notice, and authority-coordination duties apply?

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Recall/FSN notification within 10 days

recall.fsn-10-day-notification

Fact-level verified

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 later than 10 calendar days after issuance, submit progress reports until conclusion, and preferably pre-arrange email of the notice within four hours of manufacturer issuance.

Conditions

Applies to LRPs of listed devices.

The four-hour email preference is stated in the same clause.

Registration pathways

Which registration, notification, listing, reliance, or conformity route applies?

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Expedited Approval Scheme

registration.expedited-approval-scheme

Fact-level verified

Applications are processed under the Expedited Approval Scheme when the applicant is an LRP with a valid listing, no associated deaths or serious injuries or active recalls/FSCA/AEs locally and worldwide, and all devices have two or more valid independent marketing approvals; participation is default with opt-out.

Conditions

Default participation; checkbox used only to opt out.

Marketing approvals must be from jurisdictions specified in checklist item D002.

Market-access route (voluntary listing)

registration.market-access-route

Fact-level verified

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 Class A IVDMD are outside listing scope.

Conditions

Voluntary for market entry.
Mandatory for Department of Health procurement of applicable devices since 23 March 2026 (Stage C).

Listing is also the channel for post-market monitoring (AE reporting, recalls).

Novo Lane for innovative devices

registration.novo-lane

Fact-level verified

The Novo Lane prioritises processing of innovative medical device applications; qualifying criteria include first-of-its-kind devices, innovation-channel approvals (e.g. NMPA innovation list or FDA de novo) within the preceding 5 years, AI features approved within 5 years, or core technology patented within 5 years.

Conditions

At least one criterion must be satisfied; qualifying checkboxes selected in the application.

Introduced in GN-02:2026 edition.

Two listing pathways

registration.two-pathways

Fact-level verified

Listing applications follow Pathway 1 (conformity assessment by a recognised Conformity Assessment Body leading to a Conformity Assessment Certificate) or Pathway 2 (marketing approval documents from recognised regulatory jurisdictions).

Conditions

Pathway 2 jurisdictions: China, United States, European Union, Canada, Japan, Australia, South Korea, Singapore.

CAB Recognition Scheme operating since October 2006.

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

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Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

Hong Kong approvals and evidence in other markets (1 records)

ChinaHong Kong · Macau

Prior approval / evidence record

Greater Bay Area (GBA) Connect

Name: Greater Bay Area (GBA) Connect
Description: Fast-track for Hong Kong/Macau approved devices
Timeline Reduction: Access to 9 major cities
Eligibility: Hong Kong or Macau approval

医疗器械监督管理条例 (Regulations on the Supervision and Administration of Medical Devices, State Council Order No. 739). Art. 13 puts Class I on filing and Classes II and III on registration; art. 15 completes the filing on submission of conforming materials; art. 18 gives the registering authority 20 working days from receipt of the review opinion to decide NMPA service item — 进口第一类医疗器械备案 (imported Class I device filing): 办件类型即办件, filed 当场 once the materials are complete and in the required form, no fee, and Regulation No. 739 art. 15 obliges publication within 5 working days of receipt NMPA licensing service item — promised acceptance 5 working days, statutory approval clock NMPA service item — device Class III technical review 90 days (Order No. 47 Art. 92)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

Prior approvals and evidence for Hong Kong (17 records)

Hong KongUS FDA

Prior approval / evidence record

FDA 510(k)/PMA/De Novo

Authority: FDA 510(k)/PMA/De Novo
Accepted: Yes
Benefit: Satisfies D002 in place of an MDACS Conformity Assessment Certificate; a Certificate to Foreign Government may be requested

MDD Hong Kong GN-02:2026 — listing Class II/III/IV general medical devices (12-week vetting and approval)MDD Hong Kong GN-01:2025-1 — overview of the MDACS, listing scope and LRP obligations

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

Hong KongSingapore HSA

Prior approval / evidence record

Singapore HSA

Authority: Singapore HSA
Accepted: Yes
Benefit: Record of approval satisfies D002

MDD Hong Kong GN-02:2026 — listing Class II/III/IV general medical devices (12-week vetting and approval)MDD Hong Kong GN-01:2025-1 — overview of the MDACS, listing scope and LRP obligations

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

Hong KongSource authority not specified

Prior approval / evidence record

Expedited Approval Scheme (GN-02 item E002)

Name: Expedited Approval Scheme (GN-02 item E002)
Description: Streamlined review, applied by default unless the applicant opts out
Timeline Reduction: Streamlined review rather than a published shorter clock
Eligibility: Applicant is an LRP with a valid LRP listing number
No reported deaths or serious injury associated with the device, locally or worldwide
No active recalls, field safety corrective actions or adverse events, locally or worldwide
Every device in the application is supported by two or more valid, independent marketing approvals from the D002 jurisdictions

MDD Hong Kong GN-02:2026 — listing Class II/III/IV general medical devices (12-week vetting and approval)MDD Hong Kong GN-01:2025-1 — overview of the MDACS, listing scope and LRP obligations

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

Hong KongSource authority not specified

Prior approval / evidence record

Class II

class-ii

Class Name

Class II

Risk Level

medium

Pathway

MDACS listing (Form MD101 via MDIS)

Official Timeline

Min: 12
Max: 12
Unit: weeks

Verification Status

official-verified

Official Source

Title: MDD Hong Kong GN-02:2026 — listing Class II/III/IV general medical devices (12-week vetting and approval)
Url: https://www.mdd.gov.hk/filemanager/common/mdacs/GN-02-E.pdf
Accessed Date: 2026-08-30

Realistic Timeline

Min: 3
Max: 4
Unit: months

Prior Approval Benefits

A reference-market approval removes the need for an MDACS Conformity Assessment Certificate

Notes

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)

Clinical Trial Required

Local Testing Required

Gmp Required

Yes

MDD Hong Kong GN-02:2026 — listing Class II/III/IV general medical devices (12-week vetting and approval)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

Hong KongAustralia TGA

Prior approval / evidence record

Australia TGA

Authority: Australia TGA
Accepted: Yes
Benefit: ARTG certificate satisfies D002

MDD Hong Kong GN-02:2026 — listing Class II/III/IV general medical devices (12-week vetting and approval)MDD Hong Kong GN-01:2025-1 — overview of the MDACS, listing scope and LRP obligations

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

Hong KongJapan MHLW / PMDA

Prior approval / evidence record

Japan MHLW / registered certification body

Authority: Japan MHLW / registered certification body
Accepted: Yes
Benefit: Approval or certification satisfies D002

MDD Hong Kong GN-02:2026 — listing Class II/III/IV general medical devices (12-week vetting and approval)MDD Hong Kong GN-01:2025-1 — overview of the MDACS, listing scope and LRP obligations

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

Hong KongSource authority not specified

Prior approval / evidence record

Class III

class-iii

Class Name

Class III

Risk Level

high

Pathway

MDACS listing (Form MD101 via MDIS)

Official Timeline

Min: 12
Max: 12
Unit: weeks

Verification Status

official-verified

Official Source

Title: MDD Hong Kong GN-02:2026 — listing Class II/III/IV general medical devices (12-week vetting and approval)
Url: https://www.mdd.gov.hk/filemanager/common/mdacs/GN-02-E.pdf
Accessed Date: 2026-08-30

Realistic Timeline

Min: 3
Max: 5
Unit: months

Prior Approval Benefits

A reference-market approval removes the need for an MDACS Conformity Assessment Certificate

Notes

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

Clinical Trial Required

Local Testing Required

Gmp Required

Yes

MDD Hong Kong GN-02:2026 — listing Class II/III/IV general medical devices (12-week vetting and approval)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

Hong KongNMPA

Prior approval / evidence record

China NMPA IVD approval: recognised reference approval (GN-06)

reliance.china-nmpa-reliance-route-ivd

Fact-level verified

Statement: GN-06:2026 permits an NMPA registration certificate, with associated Product Technical Requirements where applicable, as a reference marketing approval supporting MDACS listing of Hong Kong Class B/C/D IVDs under D002. The Hong Kong class must be assessed separately. D003 requires the signed MDIVD-CCL; an EU ER/GSPR checklist is an alternative only with qualifying EU approval evidence. Local listing and remaining requirements still apply.
Source Jurisdiction Id: china
Source Authority Id: nmpa
Source Approval: NMPA Class II/III registration certificate; associated Product Technical Requirements where applicable
Target Jurisdiction Id: hong-kong
China Classes In Scope: NMPA-registered IVD; separately determine whether the product falls within Hong Kong Class B/C/D
Edge Type: Abridged Or Recognition Route
Market Access Strength: facilitated
Regulatory Layer: Product Marketing
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

MDACS listing remains voluntary and requires a Hong Kong Local Responsible Person.
Determine the Hong Kong risk class independently; Chinese and Hong Kong classes are not automatic equivalents.
Submit the NMPA registration certificate and associated Product Technical Requirements where applicable, explicitly covering all product models/codes.
Certificate of Free Sale may be requested.
One reference approval is not sufficient for the Expedited Approval Scheme: the separate E002 requirements include two independent approvals and the LRP/safety conditions.
Submit MDIVD-CCL; an EU ER/GSPR checklist is an alternative only when valid EU marketing approval certificates accompany the submission.

Effective from 2026-07-31

Independent review of the current official PDF on 2026-09-15: D002 identifies Chinese Mainland NMPA registration certificates; D003 retains the essential-principles checklist. No automatic risk-class mapping or retired checklist exemption is established by these items.

Hong KongSource authority not specified

Prior approval / evidence record

Class IV

class-iv

Class Name

Class IV

Risk Level

highest

Pathway

MDACS listing (Form MD101 via MDIS)

Official Timeline

Min: 12
Max: 12
Unit: weeks

Verification Status

official-verified

Official Source

Title: MDD Hong Kong GN-02:2026 — listing Class II/III/IV general medical devices (12-week vetting and approval)
Url: https://www.mdd.gov.hk/filemanager/common/mdacs/GN-02-E.pdf
Accessed Date: 2026-08-30

Realistic Timeline

Min: 3
Max: 6
Unit: months

Prior Approval Benefits

A reference-market approval removes the need for an MDACS Conformity Assessment Certificate

Notes

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

Clinical Trial Required

Local Testing Required

Gmp Required

Yes

MDD Hong Kong GN-02:2026 — listing Class II/III/IV general medical devices (12-week vetting and approval)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

Hong KongEU conformity assessment

Regulatory reference

EU MDD certificates accepted with extension declaration

reliance.eu-mdr-mdd-extension

Fact-level verified

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) 2023/607 plus the associated DoC.

Conditions

Applies to Pathway 2 applications relying on EU approvals.

Reflects the EU MDR transition extension in HK reliance practice.

Hong KongNMPA · US FDA

Prior approval / evidence record

"Novo Lane" innovative device priority (GN-02 item E001)

Name: "Novo Lane" innovative device priority (GN-02 item E001)
Description: Prioritised processing for first-of-its-kind devices, devices approved through another regulator’s innovation channel (NMPA 創新器械名錄, FDA De Novo) within 5 years, devices with AI features approved within 5 years, or devices whose core technology was patented within 5 years
Timeline Reduction: Priority in the processing queue; MDD publishes no shorter target period, and the device still needs the same D001 or D002 evidence
Eligibility: At least one of the four E001 innovation criteria
Conformity Assessment Certificate or reference marketing approval still required

MDD Hong Kong GN-02:2026 — listing Class II/III/IV general medical devices (12-week vetting and approval)MDD Hong Kong GN-01:2025-1 — overview of the MDACS, listing scope and LRP obligations

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

Hong KongNMPA

Prior approval / evidence record

China NMPA approval: recognised reference approval (GN-02 Pathway 2)

reliance.china-nmpa-reliance-route

Fact-level verified

Statement: GN-02:2026 D002 accepts an NMPA registration certificate, with associated Product Technical Requirements where applicable, as reference approval evidence for MDACS Class II/III/IV general-device listing. A003 also allows specified Chinese QMS documentation when accompanied by valid NMPA approval. E001 provides priority for eligible innovative devices, while E002 has additional conditions for expedited approval. These provisions do not grant automatic listing.
Source Jurisdiction Id: china
Source Authority Id: nmpa
Source Approval: NMPA Class II/III registration certificate; associated Product Technical Requirements where applicable
Target Jurisdiction Id: hong-kong
China Classes In Scope: NMPA Class II/III registration certificate (医疗器械注册证) -> MDACS Class II/III/IV general medical devices
Edge Type: Abridged Or Recognition Route
Market Access Strength: facilitated
Regulatory Layer: Product Marketing
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

MDACS listing remains voluntary and requires a Hong Kong Local Responsible Person.
Determine the Hong Kong risk class independently; Chinese and Hong Kong classes are not automatic equivalents.
Submit the NMPA registration certificate and associated Product Technical Requirements where applicable, explicitly covering all product models/codes.
Certificate of Free Sale may be requested.
One reference approval is not sufficient for the Expedited Approval Scheme: the separate E002 requirements include two independent approvals and the LRP/safety conditions.

Effective from 2026-07-31

Independent review of the current official PDF on 2026-09-15: D002 identifies Chinese Mainland NMPA registration certificates; D003 retains the essential-principles checklist. No automatic risk-class mapping or pre-2004 checklist exemption is established by these items.

Hong KongNMPA

Prior approval / evidence record

NMPA (Chinese Mainland)

Authority: NMPA (Chinese Mainland)
Accepted: Yes
Benefit: Registration certificate satisfies D002; pairs with a GB/T 42061 certificate or manufacturing licence as QMS evidence

MDD Hong Kong GN-02:2026 — listing Class II/III/IV general medical devices (12-week vetting and approval)MDD Hong Kong GN-01:2025-1 — overview of the MDACS, listing scope and LRP obligations

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

Hong KongHealth Canada

Prior approval / evidence record

Health Canada

Authority: Health Canada
Accepted: Yes
Benefit: Medical Device Licence satisfies D002

MDD Hong Kong GN-02:2026 — listing Class II/III/IV general medical devices (12-week vetting and approval)MDD Hong Kong GN-01:2025-1 — overview of the MDACS, listing scope and LRP obligations

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

Hong KongNMPA · US FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA · South Korea MFDS · Singapore HSA

Regulatory reference

Recognised jurisdictions for marketing approvals

reliance.recognised-jurisdictions

Fact-level verified

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 example the USA accepts 510(k), PMA or De Novo, and all model/code variants must be covered by the certificate.

Conditions

Applies to Class II/III/IV GMD listings.
The same eight jurisdictions apply to Class B/C/D IVD listings under GN-06.

A valid Certificate of Free Sale may be requested; certificates must remain valid during assessment (GN-02 clause 8.1).

Hong KongEU conformity assessment

Prior approval / evidence record

EU CE Mark

Authority: EU CE Mark
Accepted: Yes
Benefit: MDR certificates, or MDD certificates with a Regulation (EU) 2023/607 extension letter, satisfy D002; an EU ER or GSPR checklist may then replace the MD-CCL

MDD Hong Kong GN-02:2026 — listing Class II/III/IV general medical devices (12-week vetting and approval)MDD Hong Kong GN-01:2025-1 — overview of the MDACS, listing scope and LRP obligations

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

Hong KongSouth Korea MFDS

Prior approval / evidence record

South Korea MFDS

Authority: South Korea MFDS
Accepted: Yes
Benefit: Product Licence satisfies D002; pairs with a KGMP certificate as QMS evidence

MDD Hong Kong GN-02:2026 — listing Class II/III/IV general medical devices (12-week vetting and approval)MDD Hong Kong GN-01:2025-1 — overview of the MDACS, listing scope and LRP obligations

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

Review clocks

What review, validation, and applicant stop-clock rules apply?

Compare countries

12-week clock from complete submission; closure rule

review.stop-clock-closure

Fact-level verified

The 12-week review period commences only upon submission of the application AND all required supporting information, including supplementary information requested during assessment; failure to provide requested information within the stipulated timeframe results in closure of the application.

Conditions

Applies to device listing applications.
MDD may take up to 2 weeks to acknowledge receipt and assign an application number.

Stop-clock rule recorded as a fact in addition to the registration-timelines typed finding.

Special access & derogation

Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?

Compare countries

GBA urgent clinical use measure

special.gba-urgent-use-measure

Fact-level verified

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 Hong Kong public hospitals for urgent clinical use; as at 31 July 2026, 95 medical devices had been allowed in 71 designated institutions.

Conditions

Subject to approval of Guangdong Province.
Covers devices already used in Hong Kong public hospitals.

Reverse-direction special access (mainland use of HK-used devices), not an HK import route.

Submission communications & appeal

How are deficiencies answered, clocks handled, and decisions escalated or appealed?

Compare countries

Appeal outcome: 4 weeks, final, no suspension

appeal.outcome-final-no-suspension

Fact-level verified

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 appeal does not suspend the MDD decision unless MDD decides otherwise.

Conditions

Applies to appeals under GN-01 clause 5.12.

GN-10 section 8 provides a parallel appeal route for change applications.

Appeal within 14 working days

appeal.window-14-working-days

Fact-level verified

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 appeals are not considered.

Conditions

Appeal by writing to the Secretary to Medical Device Administration Appeal Committee c/o Medical Device Division.

Procedure in clauses 5.12.2-5.12.4.

UDI, listing & traceability

Which UDI, device listing, database, and traceability duties apply?

Compare countries

Patient-level tracking for high-risk devices

trace.patient-level-tracking

Fact-level verified

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-facility level is required.

Conditions

Applies to device categories listed in GN-01 Appendix 1.

Tracking records include put-into-service/implantation and retirement/explantation dates where possible.

LRP supply records retention

trace.supply-records-retention

Fact-level verified

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 seven (7) years from the date of product supplied, whichever is longer.

Conditions

Applies to LRPs of listed devices.

No UDI/UDI-DI requirement appears anywhere in the MDACS guidance corpus (GN-00 to GN-10, TR-003 to TR-008, checked 2026-08-25); traceability operates through supply records, tracking and listing numbers (HKMD No.).

Vigilance & incident reporting

What is reportable, by whom, where, in what format, and by what deadline?

Compare countries

10-day deadline for death or serious injury

vigilance.deadline-10d-death-serious-injury

Fact-level verified

Adverse events that have resulted in death or serious injury must be reported by the LRP as soon as possible, and not later than 10 elapsed calendar days after the LRP becomes aware of the incident.

Conditions

Applies to LRPs of listed devices for events in Hong Kong.

Same 10-day rule in GN-01 clause 4.4.8 for events of death, serious injury or serious public health concern.

30-day deadline for other reportable events; final report

vigilance.deadline-30d-others

Fact-level verified

All other reportable adverse events must be reported not later than 30 elapsed calendar days after the LRP becomes aware; the LRP must follow up with a final report within 30 elapsed calendar days of the initial report.

Conditions

Applies to LRPs of listed devices for events in Hong Kong.

Final report timeline in clause 6.6.

48-hour deadline for public-health-risk events

vigilance.deadline-48h-public-health

Fact-level verified

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.

Conditions

Applies to LRPs of listed devices for events in Hong Kong.

Serious public health concern is defined in GN-03 clause 3.3.

Reportable adverse event criteria

vigilance.reportable-criteria

Fact-level verified

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 event; and the event led or could have led to death or serious injury (per GN-03 clause 4.1); use errors are also reportable.

Conditions

Applies to adverse events that occurred in Hong Kong with listed devices.

Exemption rules in GN-03 clause 5.1 (e.g. deficiency found before use).

Related structured datasets

Classification systems · 2 records

Open Hong Kong IVD risk classification →

hong-kong:ivd

Jurisdiction Id

hong-kong

Domains

Name

Hong Kong IVD risk classification

Classes

Id
a
Label
IVD Class A
Normalized Risk Level
low
Id
b
Label
IVD Class B
Normalized Risk Level
medium
Id
c
Label
IVD Class C
Normalized Risk Level
high
Id
d
Label
IVD Class D
Normalized Risk Level
highest

Regulator

MDD

Official Domains

mdd.gov.hk
mdco.gov.hk
dh.gov.hk

Source Status

official-source-verified

Source Title

MDD — Overview of the Hong Kong Medical Device Listing Process (scope of MDACS and device classification)

Source Url

https://www.mdd.gov.hk/filemanager/common/information-publication/Overview%20of%20Hong%20Kong%20Medical%20Device%20Listing%20Process.pdf

Verified On

2026-08-25

Source Supports

ivd-class-axis

Notes

Classification rules for IVD medical devices are set out in MDACS technical reference TR-006; Class A IVDMDs are outside the MDACS listing scope.

Open General-device classes I–IV. →

hong-kong:medical-device

Jurisdiction Id

hong-kong

Domains

medical-device

Name

General-device classes I–IV.

Classes

Id
i
Label
Class I
Normalized Risk Level
low
Id
ii
Label
Class II
Normalized Risk Level
medium
Id
iii
Label
Class III
Normalized Risk Level
high
Id
iv
Label
Class IV
Normalized Risk Level
highest

Regulator

MDD

Official Domains

mdd.gov.hk
mdco.gov.hk
dh.gov.hk

Source Status

official-source-verified

Source Title

MDACS technical reference TR-003

Source Url

https://www.mdd.gov.hk/filemanager/common/mdacs/TR003E.pdf

Verified On

2026-08-13

Source Supports

class-axis
classification-rules

Notes

MDACS listing scope: only Class II/III/IV general medical devices (TR-003) and Class B/C/D IVDMDs (TR-006) are eligible for listing; Class I GMDs and Class A IVDMDs fall outside the listing scope.

Registration pathways, prior approvals and planning · 1 record

Open Hong Kong registration →

Country

Hong Kong

Jurisdiction Id

hong-kong

Country Code

Flag

🇭🇰

Regulator

Medical Device Division

Regulator Abbrev

MDD

Region

asia-pacific

Tier

Risk Classification

4-class (I, II, III, IV)

Classes

Id
class-ii
Class Name
Class II
Risk Level
medium
Pathway
MDACS listing (Form MD101 via MDIS)
Official Timeline
Min
12
Max
12
Unit
weeks
Verification Status
official-verified
Official Source
Title
MDD Hong Kong GN-02:2026 — listing Class II/III/IV general medical devices (12-week vetting and approval)
Url
https://www.mdd.gov.hk/filemanager/common/mdacs/GN-02-E.pdf
Accessed Date
2026-08-30
Realistic Timeline
Min
3
Max
4
Unit
months
Prior Approval Benefits
A reference-market approval removes the need for an MDACS Conformity Assessment Certificate
Notes
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)
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
Yes
Id
class-iii
Class Name
Class III
Risk Level
high
Pathway
MDACS listing (Form MD101 via MDIS)
Official Timeline
Min
12
Max
12
Unit
weeks
Verification Status
official-verified
Official Source
Title
MDD Hong Kong GN-02:2026 — listing Class II/III/IV general medical devices (12-week vetting and approval)
Url
https://www.mdd.gov.hk/filemanager/common/mdacs/GN-02-E.pdf
Accessed Date
2026-08-30
Realistic Timeline
Min
3
Max
5
Unit
months
Prior Approval Benefits
A reference-market approval removes the need for an MDACS Conformity Assessment Certificate
Notes
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
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
Yes
Id
class-iv
Class Name
Class IV
Risk Level
highest
Pathway
MDACS listing (Form MD101 via MDIS)
Official Timeline
Min
12
Max
12
Unit
weeks
Verification Status
official-verified
Official Source
Title
MDD Hong Kong GN-02:2026 — listing Class II/III/IV general medical devices (12-week vetting and approval)
Url
https://www.mdd.gov.hk/filemanager/common/mdacs/GN-02-E.pdf
Accessed Date
2026-08-30
Realistic Timeline
Min
3
Max
6
Unit
months
Prior Approval Benefits
A reference-market approval removes the need for an MDACS Conformity Assessment Certificate
Notes
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
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
Yes

Expedited Pathways

Name
"Novo Lane" innovative device priority (GN-02 item E001)
Description
Prioritised processing for first-of-its-kind devices, devices approved through another regulator’s innovation channel (NMPA 創新器械名錄, FDA De Novo) within 5 years, devices with AI features approved within 5 years, or devices whose core technology was patented within 5 years
Timeline Reduction
Priority in the processing queue; MDD publishes no shorter target period, and the device still needs the same D001 or D002 evidence
Eligibility
At least one of the four E001 innovation criteria
Conformity Assessment Certificate or reference marketing approval still required
Name
Expedited Approval Scheme (GN-02 item E002)
Description
Streamlined review, applied by default unless the applicant opts out
Timeline Reduction
Streamlined review rather than a published shorter clock
Eligibility
Applicant is an LRP with a valid LRP listing number
No reported deaths or serious injury associated with the device, locally or worldwide
No active recalls, field safety corrective actions or adverse events, locally or worldwide
Every device in the application is supported by two or more valid, independent marketing approvals from the D002 jurisdictions

Prior Approvals

Authority
FDA 510(k)/PMA/De Novo
Accepted
Yes
Benefit
Satisfies D002 in place of an MDACS Conformity Assessment Certificate; a Certificate to Foreign Government may be requested
Authority
EU CE Mark
Accepted
Yes
Benefit
MDR certificates, or MDD certificates with a Regulation (EU) 2023/607 extension letter, satisfy D002; an EU ER or GSPR checklist may then replace the MD-CCL
Authority
Health Canada
Accepted
Yes
Benefit
Medical Device Licence satisfies D002
Authority
Australia TGA
Accepted
Yes
Benefit
ARTG certificate satisfies D002
Authority
Japan MHLW / registered certification body
Accepted
Yes
Benefit
Approval or certification satisfies D002
Authority
NMPA (Chinese Mainland)
Accepted
Yes
Benefit
Registration certificate satisfies D002; pairs with a GB/T 42061 certificate or manufacturing licence as QMS evidence
Authority
Singapore HSA
Accepted
Yes
Benefit
Record of approval satisfies D002
Authority
South Korea MFDS
Accepted
Yes
Benefit
Product Licence satisfies D002; pairs with a KGMP certificate as QMS evidence

Key Requirements

Local Responsible Person incorporated or business-registered in Hong Kong, either the manufacturer or backed by a designation letter from it
Class I general medical devices and Class A IVDs cannot be listed at all — GN-01 clause 4.2.1 confines listing to Class II/III/IV devices and Class B/C/D IVDs, so there is no clock to publish for the lowest class and its absence is not a data gap
Chinese/English labelling per TR-005
QMS evidence: ISO 13485 from a GACI-signatory-accredited body, GB/T 42061, an NMPA manufacturing licence, MDSAP, or KGMP — each with its own paired marketing-approval requirement
Either an MDACS Conformity Assessment Certificate (D001) or reference-market marketing approvals (D002)
Essential Principles Conformity Checklist MD-CCL, or an EU ER/GSPR checklist where EU approvals are submitted, with supporting evidence due within 2 weeks of a request
MDACS is an administrative, voluntary system pending statutory control; listing is nonetheless required for supply into public healthcare institutions

Local Rep Required

Yes

Local Rep Name

Local Responsible Person (LRP)

Mdsap Accepted

Yes

Mdsap Benefit

Accepted as QMS evidence when paired with a marketing approval from a jurisdiction that recognises MDSAP

Registration Validity

The listing does not expire, but conditional approvals carry ongoing obligations such as annual post-market surveillance reports, and non-compliance can result in delisting

Verification Status

official-verified

Official Sources

Title
MDD Hong Kong GN-02:2026 — listing Class II/III/IV general medical devices (12-week vetting and approval)
Url
https://www.mdd.gov.hk/filemanager/common/mdacs/GN-02-E.pdf
Accessed Date
2026-08-30
Title
MDD Hong Kong GN-01:2025-1 — overview of the MDACS, listing scope and LRP obligations
Url
https://www.mdd.gov.hk/filemanager/common/mdacs/GN-01-E.pdf
Accessed Date
2026-08-30

Reviewed On

2026-08-30

Last Updated

2026-08-30

Process

Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps

Step
1
Title
Pre-Submission Preparation
Description
Gather technical documentation, quality management system (QMS) records, and clinical data required by MDD. Appoint a Local Responsible Person (LRP).
Duration
1-3 months
Icon
📋
Step
2
Title
Application Submission
Description
Submit complete registration dossier to MDD including device description, risk analysis, and testing reports.
Duration
1-2 weeks
Icon
📤
Step
3
Title
Administrative Review
Description
MDD reviews application for completeness. May request additional documents or clarifications.
Duration
2-4 weeks
Icon
🔍
Step
4
Title
Technical Evaluation
Description
In-depth technical assessment of device safety and performance. MDD may issue questions.
Duration
12 weeks
Icon
⚙️
Step
5
Title
Registration Approval
Description
Upon successful review, MDD issues Hong Kong market authorization certificate.
Duration
1-2 weeks
Icon
✅

Government fee schedules · 1 record

Open Hong Kong fees →

Jurisdiction Id

hong-kong

Country

Hong Kong

Country Code

Authority

MDD

Low Risk Local

Min: 0
Max: 0
Currency: HKD
Per Product: Yes

High Risk Local

Min: 0
Max: 0
Currency: HKD
Per Product: Yes

Details

Id
mdacs-device-listing-application
Item
MDACS device-listing application
Currency
HKD
Amount Local
0
Amount Local Formatted
HKD 0
Frequency
Per application
Notes
GN-01 section 5.4 states that the Government does not charge for inclusion in the Lists of Medical Devices or an application for inclusion.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.mdd.gov.hk/filemanager/common/mdacs/GN-01-E.pdf
Source Title
Hong Kong MDACS GN-01: no government device-listing application fee
Verified On
2026-08-25

Notes

The government application charge is HKD 0.
Conformity-assessment-body certification and other private costs are separate.

Last Updated

2026-08-25

Verification Status

official-verified

Official Sources

Title
Hong Kong MDACS GN-01: no government device-listing application fee
Url
https://www.mdd.gov.hk/filemanager/common/mdacs/GN-01-E.pdf
Accessed Date
2026-08-25

Reviewed On

2026-08-25

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record

Open Hong Kong certifications →

Slug

hong-kong

Market

Hong Kong

Confidence

low

Schemes

Id
medical-electrical-evidence
Name
Medical electrical evidence
Category
Medical Electrical Safety
Status
Included In Medical Registration
Object
Finished Device
Note
MDACS application checklist item C015: risk analysis per ISO 14971 or equivalent standards with a report or comprehensive summary, plus the list of international/national standards applied; product-specific statutory overlays apply under Cap 303/138/137/134/106; MDD maintains a recognised standards list (RS-01).
Source Binding
unresolved
Id
ofca-technical-compliance
Name
OFCA technical compliance
Category
Radio Spectrum
Status
Mandatory If Feature
Object
Radio Equipment
Note
OFCA HKCA 10XX list (read 2026-08-30) includes HKCA 1052 Issue 4 (06/2022) Performance Specification for Medical Implant Communication Systems. OFCA's ISMEM consumer page requires an Industrial, Scientific and Medical Electronic Machine Licence (HK$80/year) for a person to possess and use ISM equipment that intentionally generates and emits radio waves for industrial, scientific or medical purposes (examples named: RF probes, RF cannulae, magnetic stimulator, medical thermage machine, magnetic resonance tomography), and that equipment must be type-approved against HKCA 1007 under the Compulsory Certification Scheme. SSAC Paper 4/2026 (OFCA, for discussion 14 July 2026) restates that equipment in the scope of HKCA 1007 is classified under the Compulsory Certification Scheme of HKTEC and must be certified before use. Issue 6 of HKCA 1007 was still a proposal on that paper, so Issue 5 remains the live specification cited on the ISMEM page.
Source Binding
unresolved
Id
ofca-voluntary-certification-label
Name
OFCA voluntary certification/label
Category
Radio Spectrum
Status
Voluntary Or Procurement
Object
Exempt Or Licence Free Apparatus
Note
OFCA Short Range Devices page: Bluetooth in 2400–2483.5 MHz at up to 100 mW e.r.p. is exempt from licensing under the Telecommunications (Telecommunications Apparatus) (Exemption from Licensing) Order (Cap. 106Z) and certification against HKCA 1035 is voluntary. Generic SRD in 433.00–434.79 MHz at up to 10 mW e.r.p. sits under the Class Licence for Short Range Devices with voluntary certification against HKCA 1061. This is the opposite of the ISMEM/HKCA 1007 compulsory route.
Source Urls
https://www.ofca.gov.hk/en/consumer_focus/guide/help_for_consumers/information_on_radio_applications/short_range_devices/index.html
Source Binding
candidate
Id
dealer-licence
Name
Dealer licence
Category
Telecom Network Attachment
Status
Mandatory If Feature
Object
Dealer Activity
Source Binding
unresolved
Id
radiation-authorization
Name
Radiation authorization
Category
Ionizing Radiation
Status
Mandatory If Feature
Object
Product Or Use Site
Note
MDACS product-specific overlays name Cap 303 Radiation Ordinance. Hong Kong e-Legislation is a JavaScript application; the Cap 303 section text was not recovered from this egress, so the licence trigger is not claimed from the Ordinance body. Retry condition: a reachable HKeL print of Cap 303 ss. 7–9.
Source Binding
unresolved

Official Sources

Authority
OFCA
Topic
telecommunications standards information notes
Url
https://www.ofca.gov.hk/en/industry_focus/standards/tel_standards/telecom/information_notes/index.html
Authority
OFCA
Topic
certification bodies and voluntary labelling
Url
https://www.ofca.gov.hk/en/industry_focus/standards/tel_standards/telecom/list_of_certification_bodies/index.html
Authority
Medical Device Division
Topic
GN-02 application documents ISO 14971 risk analysis checklist
Url
https://www.mdd.gov.hk/filemanager/common/mdacs/GN-02-E.pdf
Authority
OFCA
Topic
HKCA 10XX list including HKCA 1052 Medical Implant Communication Systems
Url
https://www.ofca.gov.hk/en/industry_focus/standards/tel_standards/hkca/radio_equipment_specifications/index.html
Authority
OFCA
Topic
ISMEM licence and compulsory certification against HKCA 1007
Url
https://www.ofca.gov.hk/en/consumer_focus/guide/help_for_consumers/information_on_radio_applications/industrial_scientific_and_medical_electronic_mach/index.html
Authority
OFCA
Topic
Short Range Devices — Cap. 106Z exemption and voluntary HKCA 1035/1061 certification
Url
https://www.ofca.gov.hk/en/consumer_focus/guide/help_for_consumers/information_on_radio_applications/short_range_devices/index.html
Authority
OFCA
Topic
SSAC Paper 4/2026 — HKCA 1007 remains compulsory certification under HKTEC
Url
https://www.ofca.gov.hk/filemanager/ofca/en/content_751/SSAC_Paper_4_2026.pdf