This page covers the regulatory authority, device classification, registration process, local representative requirements and FAQs for medical device registration in Hong Kong. Medical devices in Hong Kong are regulated by the Medical Device Division (MDD) of the Department of Health, and EVERBIZ can support you through the entire process from classification to listing.
1. Regulatory Framework: Voluntary Today, Mandatory Tomorrow
Hong Kong’s medical device regulatory system is completely independent from that of Mainland China. It is currently administered by the Medical Device Division (MDD) of the Department of Health through the Medical Device Administrative Control System (MDACS). In place since 2004, MDACS is a transitional framework in preparation for future statutory regulation.
Key trends:
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June 2024: A Preparatory Office for the Centre for Medical Products Regulation was set up under the Department of Health
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9 July 2025: The Department of Health announced that the Centre for Medical Products Regulation (CMPR) will be formally established by the end of 2026
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Within the next 12 months: Legislative proposals will be submitted to the Legislative Council
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MDACS will then become a mandatory registration system
Strategic note: Products currently listed under MDACS will be carried over directly into the future mandatory register without the need to reapply. Registering early is key to gaining a compliance head start.
2. Risk Classification
MDACS uses a four-tier risk classification consistent with GHTF / IMDRF:
| General medical devices | Risk | Corresponding IVD class | Eligible for MDACS listing? |
|---|---|---|---|
| Class I | Low | Class A | No (not eligible) |
| Class II | Low–moderate | Class B | Eligible |
| Class III | Moderate–high | Class C | Eligible |
| Class IV | High | Class D | Eligible |
Class I general medical devices and Class A IVDs are not eligible for MDACS listing – a key difference from most regulatory systems.
3. Why Register Voluntarily?
Although voluntary in name, MDACS listing has in practice become a de facto market entry requirement:
1. Mandatory for public hospital procurement
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From 1 November 2024: All procurement by Hospital Authority and Department of Health public hospitals and clinics must be for MDACS-listed products
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Quotations must include the MDACS listing number or application number
2. Preferred by private healthcare providers and insurers
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Private hospitals and large distributors commonly require MDACS listing
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Some medical insurance reimbursements are conditional on MDACS listing
3. Protection during the legislative transition
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Listed products will directly retain their status under the CMPR regime
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When mandatory registration starts, unlisted products will face a review backlog
4. Local Responsible Person (LRP)
Overseas manufacturers must appoint a Local Responsible Person (LRP) – a legal entity or individual registered in Hong Kong. The LRP is responsible for:
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Submitting and holding the MDACS listing
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Maintaining product information and notifying changes
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Adverse event reporting – post-market vigilance
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Notifying field safety corrective actions (FSCA)
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Serving as the official point of contact with the MDD
The LRP does not have to be involved in importation (since April 2022) – a notable difference from most Asia-Pacific markets, allowing the LRP and distribution to be managed separately.
5. Registration Process
Step 1 — Product classification: Determine Class II–IV / B–D according to the MDACS classification rules; the MDD provides an online classification tool. SaMD / SiMD is classified as an active medical device under TR-007.
Step 2 — Appoint an LRP
Step 3 — Prepare the application dossier
Core requirements:
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Proof of approval from a reference jurisdiction – from any of the following:
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US FDA
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European Union (CE)
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Health Canada
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Australia TGA
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Japan PMDA
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China NMPA
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Korea MFDS
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Singapore HSA
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Quality system certificate: ISO 13485 or FDA Establishment Inspection Report
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Technical product information: product description, intended use, specifications, labeling, IFU
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MDACS application form
Step 4 — Alternative route: local Conformity Assessment Body (CAB)
If there is no reference-country approval, a local assessment must be performed by a Hong Kong-recognized Conformity Assessment Body (CAB). Currently recognized CABs include:
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BSI
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SGS
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TÜV SÜD
CAB assessment fees are paid separately to the assessment body.
Step 5 — Submit via MDIS: Applications are submitted electronically through the Medical Device Information System (MDIS).
Step 6 — MDD review: The official review time is 12 weeks, but in practice it can take 9–12 months (up to 24 months for high-risk or complex products).
Step 7 — Obtain a listing number: Once approved, the product is entered in the public List of Medical Devices database and receives a Medical Device Listing Number, which can be used in commercial documents and tender quotations.
6. Faster Review: Expedited Approval Scheme
Made a formal mechanism in 2022, applicable when:
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Class II–IV medical devices and Class B–D IVDs
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Approved by two or more independent reference jurisdictions
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No record of serious adverse events
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No adverse events under investigation
Reference jurisdictions: US, EU, Canada, Australia, Japan, China, Korea
See guidance document GN-02. Review times are significantly shorter, although no specific timeline commitment has been published.
7. Validity and Renewal
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MDACS listing validity: 5 years
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Renewal is a simplified administrative process that does not require resubmission of the full technical file
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Significant changes (specifications, indications, manufacturer, etc.) must be notified promptly
8. Official Fees and Costs
MDD fees: There is no government fee for MDACS listing – a unique advantage of the Hong Kong system.
Actual costs mainly come from:
| Item | Reference cost |
|---|---|
| Annual LRP service fee | USD 2,000–5,000 |
| CAB local assessment (if no reference-country approval) | USD 5,000–15,000+ |
| Obtaining ISO 13485 certification | Depends on the certification body |
| Regulatory consulting fees | USD 3,000–10,000 |
| Document translation (if needed) | Based on word count |
9. Key Compliance Points
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No mandatory local testing – Hong Kong does not require testing by local laboratories
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No mandatory local clinical studies – overseas clinical data may be used
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Country-of-origin approval not mandatory – a CAB assessment is acceptable, but reference-country approval speeds things up significantly
10. Post-Market Obligations
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Adverse event reporting – via the Medical Device Adverse Event Reporting System
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Field Safety Corrective Action (FSCA) notifications
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Product change notifications
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Renewal management – renew before the 5-year expiry
Current limitation: The MDACS adverse event system only covers listed products. Adverse events involving unlisted devices can currently only be reported through the Consumer Council or Customs. Once the CMPR is established, a unified mandatory reporting system will be introduced.
11. Special Mechanism: GBA Connect Scheme (Greater Bay Area)
Medical devices registered in Hong Kong can, under certain conditions, enter the Greater Bay Area market through the GBA Connect Scheme:
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As of December 2025: 71 designated hospitals – located in Shenzhen, Guangzhou, Zhuhai and other major Greater Bay Area cities
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Applies to medical devices, IVDs and drugs that are urgently needed clinically and have no equivalent on the Mainland
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A special channel for overseas products to enter Mainland China via Hong Kong
12. Recent Key Changes (Timeline)
| Date | Event |
|---|---|
| April 2022 | LRP no longer required to be involved in importation; LRP and distribution can be separated |
| 2022 | Expedited Approval Scheme moved from pilot to formal mechanism |
| June 2024 | CMPR Preparatory Office established |
| 1 November 2024 | MDACS listing becomes mandatory for procurement by public hospitals and Department of Health clinics |
| 9 July 2025 | Department of Health announces CMPR to be established by the end of 2026 |
| September 2025 | Singapore HSA and Hong Kong DH sign a regulatory cooperation MOU |
| November 2025 | 2025 Greater Bay Area Medical Products Regulation Conference held in Hong Kong |
| End of 2026 | CMPR formally established; MDACS transitions to a statutory regime |
Strategic Value
Opportunities:
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No government registration fees – a cost-friendly structure
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Alignment with international standards – a broad list of reference jurisdictions, including NMPA, which is favorable to Chinese manufacturers
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No local testing, no local clinical studies – technical documentation can be largely reused
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5-year validity + simplified renewal – low long-term compliance costs
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GBA Connect – a special channel into the Mainland market
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Mandatory for public hospital procurement – already a de facto market requirement
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CMPR legislative window – current registrants will benefit from transitional arrangements
Challenges:
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Relatively long review times (12 weeks officially vs. 9–24 months in practice)
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Without reference-country approval, a CAB assessment is required, at relatively high cost
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Class I / Class A IVD devices cannot be listed – market access for these products depends on other evidence
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Uncertainty during the legislative transition – specific compliance requirements after CMPR launches are still to be defined by legislation
How EVERBIZ Can Help
EVERBIZ has offices in Shanghai, Hong Kong, Germany, Austria, Singapore, Malaysia, Thailand and Vietnam. For the Hong Kong market, we offer:
- Product classification and registration pathway planning
- Preparation and review of listing application documents
- Local authorized representative / registration holder arrangements
- Submission, responses to deficiency letters and progress tracking
- Post-market compliance maintenance (changes, renewals, adverse event reporting)
Contact us for a Hong Kong medical device registration plan and quote, or see our registration services for other countries and regions.
Hong Kong Medical Device Registration FAQs
Which authority regulates medical devices in Hong Kong?
The Medical Device Division (MDD) of the Department of Health administers medical devices through the Medical Device Administrative Control System (MDACS), which is currently a voluntary listing system.
Is a local responsible person required for MDACS listing?
Yes. Applications must be submitted by a Hong Kong Local Responsible Person (LRP), who also bears post-market responsibilities.
How are medical devices classified in Hong Kong?
General medical devices are classified by risk into Class I to Class IV; IVD medical devices follow separate classification rules.
How long is an MDACS listing valid?
A listing is generally valid for 5 years and must be renewed before it expires.