Hong Kong Medical Device Registration
Medical Device product registration in Hong Kong is managed by the Medical Device Division (MDD) of the Department of Health, formerly known as the Medical Device Control Office (MDCO).
Currently, medical device product registration is voluntary in Hong Kong for Class II and above medical devices and Class 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.
Medical device classification closely follows the Global Harmonization Task Force (GHTF) classification guidelines, with Class I, II, III and IV designations ranked from low to high risk categorization.
Device Conformity Assessment
Medical Device registration in Hong Kong 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 MDCO 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.
Australia – Canada – European Union – Japan – United States
Approvals by China or Korea have also been successfully piloted and will be formally available soon.
Validity and Renewal
Listings are valid for 5 years and are renewed through a straightforward administrative process..
License Holder Requirements
A Licensed Local Responsible Person must submit the registration application(s) and hold the license after.
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 change application.
A change 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
- EC Certificate
- Product labeling (representative sample)
- Supporting documentation from Asia Actual
- LRP Documentation procedure
- Asia Actual’s original Business Registration (BR) license
- Asia Actual’s company chop
Benefits of Asia Actual as the Independent License Holder/Virtual Sole Importer
- 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 if you are interested in voluntarily registering your medical device in Hong Kong.
Hong Kong Regulatory Support
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.”
US: +1 512 898-9222
SG: +65 3138-4148
Latest Market Updates
- NMPA to Pilot Program Allowing Hong Kong Approved Products to Be Sold in Mainland ChinaDecember 16, 2020 - 4:59 pm
- Voluntary Medical Device Registration in Hong KongJuly 10, 2020 - 11:17 pm
- HONG KONG EXTENDS PILOT PROGRAM TO RECOGNIZE CHINA AND KOREA AS REFERENCE COUNTRIESJune 10, 2020 - 8:00 pm
- MEDICAL DEVICES SHIPMENTS DURING THE COVID-19 PANDEMICJune 4, 2020 - 8:28 pm
- 4 PRODUCT DEVELOPMENT DECISIONS THAT IMPACT SALES PERFORMANCE IN ASIAOctober 2, 2019 - 6:51 pm