Medical Device Listing in Hong Kong
Government Authority
Medical Device listings in Hong Kong are managed by the Medical Device Division (MDD) of the Department of Health, formerly known as the Medical Device Control Office (MDCO).
Hong Kong Medical Device Regulations
Guidance Notes: GN-00 through GN-10
Technical References: TR-001 through TR-008
Code of Practice: COP-01 through COP-04
RS-01: List of Recognized Standards for Medical Devices
Regulatory Efficiency
Currently, medical device listing is voluntary in Hong Kong for Class II and above medical devices and Class B, C, and D IVD devices. While registration is voluntary, the Hospital Authority requires, or gives preference to, registered medical devices during public hospital tenders. Devices can be registered voluntarily through the Medical Device Administrative Control System (MDACS).
Medical Device Status
Products that make diagnostic, therapeutic, medical or rehabilitative claims are considered Medical Devices in Hong Kong. Devices with a drug component and devices that emit radiation or radio wave energy may be subject to additional non-medical ordinances.
Per Technical Reference TR-007, Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) are considered medical devices.
Product Classification
Manufacturers should refer to the MDD’s Technical Reference TR-003 for medical device classification guidance. Classification principles closely align with the Global Harmonization Task Force (GHTF) guidelines, with Class I, II, III and IV designations ranked from low to high risk. Click the following links to learn more classifying and grouping your devices in Hong Kong.
Classification of software medical devices also follows the risk-based classification principles outlined in . Software devices are considered active medical devices and classified in accordance with the formal intended use statement. To learn more listing SaMD and SiMD in Hong Kong, please see our blog on the topic here.
Device Conformity Assessment
Pending the enactment of legislation, which is expected in the coming years, an administrative control system called Medical Device Administrative Control System (MDACS) has been set up to facilitate the transition to the long-term statutory control and is managed by the MDD.
The Medical Device Administrative Control System has the following features:
- a listing system for medical devices, under which manufacturers and importers of medical devices could voluntarily list their medical devices with the Department of Health; and
- an adverse incident reporting system, through which the manufacturers, importers, users, and the general public could report adverse incidents to the Department of Health for evaluation to reduce the likelihood of, or to prevent repetition of adverse incidents, or alleviate consequences of such repetition.
Regulatory Process
Currently, there is no specific legislative control over the importation and sale of medical devices in Hong Kong and therefore, registration is currently voluntary for Class II and above medical devices and Class D IVD devices. However, devices with a drug component or that emit radiation or radio wave energy may be subject to requirements from other ordinances. The Hospital Authority also requires (or gives preference to) registered medical devices in public hospital purchasing. To date over 4,000 devices have been listed on the MDACS system under the voluntary system.
Applicants may submit evidence of reference country approval in lieu of undergoing local conformity assessment by a registered Conformity Assessment Body (CAB). ISO 13485 or an FDA Establishment Inspection Report is required to demonstrate quality systems conformity.
Registration applications must be submitted by a local, licensed business entity known as a Local Responsible Person (LRP) that also has post-market vigilance responsibilities for registered medical devices (as well as devices under the application review process).
The official application processing time for the MDD is 12 weeks, however, delays of up to 50 weeks are common, meaning application reviews can last up to 24 months. There are no government processing fees. Successful device applications will receive a listing number and will be placed in the MDD online database, MDACS. Listings are valid for 5 years.
Listing Products Not Approved by a Reference Country
Medical device listing in Hong Kong for products without Reference Country approval requires a local conformity assessment conducted by a Conformity Assessment Body (CAB), of which three companies are currently qualified: BSI, SGS, and TUV SUD. Local conformity assessments require a MDACS form, Instruction for Use (IFU), summaries on available clinical data and, in certain cases, test reports or other data in addition to fees paid to the CAB.
Application processing time is about 12 weeks, with no associated processing fees.
Successful device applications will receive a listing number and be listed in the MDD on-line database
Asia Actual maintains an easily searchable database and can provide manufacturers with data specific to their product’s AMDNS code and/or competitors.
Quality Systems Conformity Assessment
ISO 13485 or FDA Establishment Inspection Report is required to register all classes of devices.
Exceptions to Local Conformity Assessment Requirements
Applicants may submit reference country approval in lieu of undergoing a local conformity assessment by a CAB.
Reference Countries
Australia – Canada – European Union – Japan – United States – China – Korea – Singapore
Expedited Approval Scheme
Formalized in January 2022, the Expedited Approval Scheme (previously a trial scheme) provides qualifying Class II, III, and IV applications with a quicker review. To qualify, products will need to have 2 Reference Country approvals, no serious adverse events, and no ongoing adverse events. Reference Countries include the US, Canada, Europe, Australia, Japan, China, Korea and Singapore. The MDD’s formal guidance can be found here under GN-02. Official review times have not been provided yet but the MDD assures manufacturers that the applications will receive a more expedited review.
Validity and Renewal
Listings are valid for 5 years and are renewed through a straightforward administrative process.
License Holder Requirements (LRP)
A Licensed Local Responsible Person (LRP) must submit the registration application(s) and hold the license after but does not need to be part of the importing process. LRPs will correspond with the MDD on the manufacturer’s behalf and organize all post market surveillance activities.
License Transfer
Medical device registration applications must be submitted by a local entity that also acts as license holder, or Local Responsible Person (LRP). The LRP is the key point of contact for the MDD when it comes to the device listing. Target timelines for application processing is 12 weeks. There are no MDD fees to process the transfer application.
A transfer application is required with the following documents:
- “Transfer Form” signed by current LRP, Asia Actual Hong Kong and client
- LRP Designation Letter from client to Asia Actual Hong Kong
- Supporting documentation (from client)
- ISO 13485
- Marketing approval certificate (i.e. EC Certificate)
- Product labeling (representative sample)
- Supporting documentation from Asia Actual
- LRP Documentation procedure
- Asia Actual’s original Business Registration (BR) license
Benefits of Using Asia Actual as Your Independent License Holder (LRP)
- Sell directly to multiple regional distributors (avoiding mark-up by a national importer)
- Increase transfer pricing
- Improve leverage in distributor negotiations/responses
- Add or change distributors as required
- Keep intellectual property away from local commercial agents
- Easy, expedited registrations for distributors
- Assure expert handling of post market vigilance and license maintenance
Contact Asia Actual for assistance with your medical device listing in Hong Kong or to confirm the cost and time lines that apply to your specific devices of interest. Asia Actual has experienced, bi-lingual consultants in Hong Kong to manage the application, importing, and post-market surveillance needs.
Bryan’s Regulatory Hint
“Registering your medical device through the voluntary system is beneficial, because Hong Kong’s Hospital Authority gives preference to registered medical devices.”
Contact Us
US: +1 512 898-9222
SG: +65 3138-4148
EMAIL: Hongkong@asiaactual.com
Latest Market Updates
Hong Kong Increases Prioritization of Registered Medical DevicesJuly 12, 2024 - 8:15 am
Hong Kong Prepares Office for Mandatory Medical Device RegulationsJune 14, 2024 - 2:19 pm
Hong Kong MDD Adds Singapore as Reference CountryApril 4, 2024 - 8:38 am
Hong Kong MDD Adds China and Korea to List of Reference CountriesJanuary 29, 2024 - 11:36 am
Hong Kong MDD Issues New Technical Reference Document for AI-MDJanuary 22, 2024 - 3:01 pm
Frequently Asked Questions – Hong Kong Medical Device Registration Requirements
Do I need to register my medical device in Hong Kong?
No, as of January 2024, listing medical devices in Hong Kong is currently voluntary though there are plans to begin requiring registration in the near future. While listing is technically voluntary, manufacturers that intend to sell to public hospitals will need to register their products before they can take part in public tenders which accounts for ~90% of hospital purchases.
Who can submit submit applications in Hong Kong?
A local entity must submit applications, hold the license, and correspond with the Medical Device Division (aka MDD; formerly known as the Medical Device Control Office (MDCO). License Holders do not need to be part of the importing process.
How are products classified in Hong Kong?
Medical device classification is covered under Technical Reference TR-003 and closely aligns with the Global Harmonization Task Force (GHTF) classification guidelines, with Class I, II, III and IV designations ranked from low to high risk categorization.
Click the following links to learn more classifying and grouping your devices in Hong Kong.
Click here to learn more about classifying and listing your SaMD/SiMD.
How long does it take to register my medical device in Hong Kong?
As of January 2024, it’s expected that applications with reference country approval will be approved in 10-15 months. Contact us for the latest timelines.
How much does it cost to register my device in Hong Kong?
As of January 2024, the MDD does not charge any review fees.
How long are medical device licenses valid in Hong Kong?
Listings are valid for 5 years and are renewed through a straightforward administrative process.
Does the license holder need to be a part of the importing process?
No, license holders do not need to be part of the importing process as of April 2022.
Is there an expedited review pathway in Hong Kong?
Yes. Products with 2 independent Referency Country approvals are eligible for the Expedited Approval Scheme (previously a trial scheme).
Requirements for the Expedited Approval Scheme are as follows:
- Products will need to have 2 independent Reference Country approvals, no serious adverse events, and no ongoing adverse events.
- Reference Countries include the US, Canada, Europe, Australia, Japan, China, and Korea.
The MDD’s formal guidance can be found here under GN-02. Official review times have not been provided yet but the MDD assures manufacturers that the applications will receive a more expedited review.
Is ISO 13485 required for medical devices in Hong Kong?
Yes, ISO 13485 or FDA Establishment Inspection Report is required to register all classes of devices.
Is Home Country approval required?
No, there are no requirements for home country approval but Reference Country approval can expedite the review process.
Do documents need to be translated as part of the application process?
No, application documents can be submitted in English.