MDD Hong Kong Medical Device Registration

Medical devices and IVDs in Hong Kong are overseen by the Medical Device Division (MDD) There are no specific regulations government medical devices available in Hong Kong; key documents outlining device “registration” (listing) processes and requirements are issued as Guidance Notes (GN) and Technical References (TR).

Key documents include:

• GN-01 (Overview of MDACS)

• GN-02 (Listing Class II/III/IV General Medical Devices)

• GN-06 (Listing Class B/C/D IVD Medical Devices)

• GN-03 (Adverse Event Reporting by LRPs)

• TR-002 (STED)

• TR-004 (Essential Principles of Safety and Performance for Medical Devices)

Hong Kong’s medical device regulatory framework is established under the Medical Device Administrative Control System (MDACS), which includes a device listing system (via the Medical Device Information System (MDIS)) and an adverse event reporting system. Device listing is voluntary but listed devices are preferred for participation in public hospital tenders.

All devices listed by manufacturers with no entity in Hong Kong need a Local Responsible Person (LRP). Only the LRP can submit the listing application, and the LRP has defined pre- and post-market obligations.

Hong Kong Medical Device and IVD Classification

Hong Kong classifies medical devices and IVDs in line with IMDRF principles. Medical devices are classified as Class I, II, III, and IV; IVDs are classified as Class A, B, C, and D.

Hong Kong (MDD) medical device regulatory pathways

MDD has established MDACS listing pathways for Class II/III/IV general medical devices and Class B/C/D IVDs based on existing reference country approval and market history. Class I devices are not listed. MDACS listing requires a Conformity Assessment Certificate from an MDACS-accredited conformity assessment body (CAB). CAB review is not required for devices with approval in one of Hong Kong’s approved reference markets: Australia, Canada, the European Union, Japan, the United States, Mainland China, South Korea, or Singapore.

Standard MDACS listing route (with and without reference market approval)

• Process: the LRP applies for inclusion into the List of Medical Devices via the MDIS.

• Documentation requirements:
  
  • application form
  • evidence of quality management system (QMS) consistent with ISO 13485
  • technical documentation in STED format
  • classification rationale
  • labeling samples
  • Conformity Assessment Certificate from MDACS accredited certification body
  • Devices with valid approvals in reference markets must include relevant documentation (in this case, an Essential Principles checklist is also required)

• Timeline: vetting and approval of a listing application should be completed within 12 weeks of submitting the application, but actual review times can be much longer (up to 24 months).

• Renewal: Listing approval (including conditional approval) is valid for five (5) years. Renewal applications should be submitted between 12 weeks and 1 year before expiry; if the listing expires, a new application is required.

Expedited Approval Scheme (selected Class II/III/IV general medical devices; Class B/C/D IVDs)

MDD offers an Expedited Approval Scheme intended to streamline review for eligible MDACS listing applications.

• Criteria: No reported deaths/serious injury; no active recalls or field safety corrective actions; and two or more valid reference market approvals.

• Process: the LRP applies for inclusion into the List of Medical Devices via the MDIS.

• Documentation requirements:
  
  • application form
  • evidence of quality management system (QMS) consistent with ISO 13485
    
  • technical documentation in STED format
  • classification rationale
  • labeling samples
  • Relevant documentation for approvals in two reference markets
  • Declaration of no global safety issues

• Timeline: There is no official turnaround time but applications are reviewed on a priority basis.

• Renewal: Listing approval is valid for five (5) years. Renewal applications should be submitted between 12 weeks and 1 year before expiry; if the listing expires, a new application is required.

Other MDACS listing requirements (Hong Kong)

• Local Responsible Person (LRP): Mandatory for MDACS device listing submissions for manufacturers with no presence/entities in Hong Kong. The LRP is the applicant of record and must support MDD requests for additional information and inspection of originals/certified copies.

• No government application fee: MDD states no fee is charged for inclusion of devices into the MDACS lists (companies should still plan for third-party or operational costs).

• Labelling and IFU package: Labeling and IFU can be in English, Chinese, or both. Devices intended for home or lay-use must be labeled in English and Chinese.

• Post-market obligations: LRPs must report adverse events within defined timeframes. Device tracking to the user level is required for certain device types.

What documentation is required to list a medical device or IVD in Hong Kong?

Documentation requirements vary by device type (general vs IVD), risk class, and whether you pursue the standard route or the expedited scheme. However, a complete package commonly includes:

• Technical documentation in STED format

• Evidence demonstrating conformity to Essential Principles, which includes a CAB review certificate or marketing authorization documents from an approved reference market

• Labelling samples and IFU

• A clear classification rationale per MDACS rules

• QMS evidence aligned to ISO 13485

• For the Expedited Approval Scheme, documentation supporting the eligibility criteria and the required set of independent regulatory approvals

What is a Hong Kong Local Responsible Person (LRP) and why do you need one?

The Local Responsible Person (LRP) is the Hong Kong-based entity that serves as the official applicant for MDACS device listing. The LRP serves as the primary regulatory interface between the foreign manufacturer and the MDD. The LRP submits and maintains device listing applications, ensures effective communication with users, distributors, and authorities, and maintains comprehensive supply and traceability records for at least the device lifetime or seven years, whichever is longer. They must operate a documented complaint handling system, arrange maintenance and service support where applicable, and implement tracking systems for specified high-risk devices, including annual surveillance reporting. The LRP is also responsible for reporting adverse events within defined timelines, notifying the MDD of recalls and field safety notices, managing corrective actions, and making records available for inspection upon request.