Registration of medical device in Hongkong
Hong Kong’s sophisticated medtech market is experiencing high demand for advanced devices driven by its rapidly aging population. Registering your device under the voluntary MDACS provides an immediate and crucial competitive advantage and ensures readiness for the upcoming mandatory regulatory system. This proactive step is essential to secure preferential access to Hong Kong's public and private healthcare procurement.
Legislative background
Medical device division under department of health is responsible for implementing the Medical Device Administrative Control System (MDACS) and developing a long-term statutory regulatory framework for medical devices.
Strangely there is no law superordinate as MDR in EU but just a framework of MDACS. Practically there are clear guidance note, technical reference, code of practice and other documents covering whole process from registration to post market.
There are 4 classes of medical device I, II, III, and IV and In Vitro Diagnostic A, B, C D. Only class II to IV medical devices and IVD B to D are voluntarily for listing. In terms of medical device information system as of 2024, medical device will be online listed.
Despite being voluntary, having a device listed is often essential, as the Hospital Authority (HA) and the Department of Health (DH) prioritize or require listed products for public hospital tenders and government procurement.
Prerequisite of expedited approval scheme
- Only the Local Responsible Person (LRP) in Hongkong may make the application to list product for foreign manufacturer.
- Two or more of the marketing approval documents from recognized regulatory jurisdictions (including China, United States, European Union, Canada, Japan, Australia, South Korea, and Singapore)
- A valid quality management system
- Product should not have record of serious adverse event or recalls at international market
Standard pathway
*if manufacturer has no reference market approval, an extensive application through Conformity Assessment Body is possible
Lifecycle of medical device (IVD) in Hongkong
The first step is to define whether your product is medical device or IVD and under which classification in Hongkong.
Through local responsible person the technical documentation will be prepared.
The review time of class B to D IVD or II to IV medical device takes 84 working days after online submission of technical documentation.
There is no government fee to list either medical device or IVD in Hongkong.
After approval the certificate is 5 years valid. Every 5 years product certificate must be renewed.
After approval manufacturer has the following obligations:
- Report vigilance
- Report product change
- Safety report prior to renewal
- Inspection by authority
Technical documentation in Hongkong
Here below are all documents needed:
- Letter for designating to LRP
- Business licence of LRP
- Marketing approval documents
- ISO 13485 certificate or related
- Essential principles
- Clinical evaluation report
- Labelling: compliant to requirements Hong Kong (TR-005)
*CAB conformity assessment certificate for standard pathway.
Relation to fast track approval in Guangdong-Hong Kong-Macao Greater Bay Area港澳药械通
The core of the new regulation as of Nov. 2025 is the "Guangdong-Hong Kong-Macao Greater Bay Area Inland Nine Cities Clinical Urgent Imported Hong Kong and Macao Drug and Medical Device Catalog Management Measures" which dictates the process for including a Hong Kong-listed medical device in the scheme's approved list.
Prerequisites
The device must be: A) Clinically urgent, and B) Already marketed in Hong Kong/Macao and, for devices, procured and used by public hospitals in those regions, possessing "clinical application advancement."
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