🇭🇰 Hong Kong IVD regulatory data

hong-kong:ivd

hong-kong

• ivd

Hong Kong IVD risk classification

• 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

MDD

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

official-source-verified

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

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

2026-08-25

• ivd-class-axis

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

Hong Kong

hong-kong

HK

🇭🇰

Medical Device Division

MDD

asia-pacific

2

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

• 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

• 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

• 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

• 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

Yes

Local Responsible Person (LRP)

Yes

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

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

official-verified

• 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

2026-08-30

2026-08-30

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

  ✅

hong-kong

Hong Kong

HK

MDD

Min

0

Max

0

Currency

HKD

Per Product

Yes

Min

0

Max

0

Currency

HKD

Per Product

Yes

• 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

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

2026-08-25

official-verified

• 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

2026-08-25

exact-current

Yes

hong-kong

Hong Kong

low

• 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

• 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