MDD Hong Kong Medical Device Registration

Medical devices and IVDs in Hong Kong are overseen by the Medical Device Division (MDD). MDACS is an administrative listing and monitoring framework supported by Guidance Notes and Technical References; other applicable laws and procurement requirements still need assessment.

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. MDACS listing is voluntary under the administrative system, while specific public procurement requirements can make listing important for a particular tender. Do not equate that with one universal requirement for every hospital purchase.

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 and local-responsibility records; accepted QMS evidence; technical documentation in the required STED format; classification rationale; labeling/IFU samples; and the applicable conformity evidence. Use the accepted reference-market approval documents or an MDACS CAB certificate as appropriate, together with the required Essential Principles declaration/checklist.

• Timeline: vetting and approval of a listing application should be completed within 12 weeks of submitting the application, after all required supporting information is available; applicant questions and dossier readiness can extend total calendar time.

• 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: The applicable application, QMS, technical, classification and labeling records, together with evidence of the required reference-market approvals and the scheme-specific safety declaration. Verify the current expedited criteria for the actual product and approvals.

• 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

• Labeling 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 liaison between the manufacturer and the MDD. An LRP is required for foreign manufacturers seeking registration; local manufacturers can also appoint an LRP to facilitate the registration process.

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.

Current listing and procurement decision record

The MDACS overview and activities register record current guidance and updates. Department of Health Stage C procurement measures took effect March 23, 2026; assess that scope separately from the voluntary listing framework. Listing is not an unrestricted approval of every claim or a replacement for other applicable controls.