Hong Kong Medical Device Registration
Medical device registration, or “Listing” as it is known in Hong Kong, is voluntary at present. Manufacturers can apply for a Voluntary Listing through the Medical Device Administrative Control System (MDACS). This system is managed by the Hong Kong Medical Device Division (HKMDD) of the Department of Health. While listing is not mandatory, it is requested by public hospitals and procurement bodies.
How to List a Medical Device in Hong Kong Special Administrative Region
To list a medical device under MDACS, applicants, including foreign manufacturers, must first appoint a Local Responsible Person (LRP). Then, submit the application to the HKMDD with the following:
The importation of medical devices into Hong Kong involves regulatory processes where local businesses may act as responsible entities. While there is a lack of specific legislative control over the importation and sale of medical devices, certain classes may require voluntary registration or approval under other ordinances.
*If the device lacks approval from recognized reference markets, a local conformity assessment by a Conformity Assessment Body (CAB) may be required, with associated fees.
Upon successful review, the device is listed in the Administrative Control System MDACS database with a Medical Device Listing Number.
Role of the Local Responsible Person (LRP)
The Local Responsible Person (LRP) plays a crucial role in the device registration process in Hong Kong. The LRP is responsible for submitting the registration application and holding the license. The LRP must be a local, licensed business entity and is the key point of contact for the MDD.
The LRP is also responsible for post-market surveillance, including reporting adverse events and incidents related to the device. Please refer to our dedicated page for more information about Cisema's role as Local Responsible Person (LRP).
Conformity Assessment (CA) for Medical Devices
This is a critical step in the device registration process in Hong Kong. Manufacturers must demonstrate that their devices comply with the regulatory requirements, including safety and performance standards. The CA involves providing documentation, such as test reports and clinical data, to support the device’s safety and efficacy.
The MDD may request additional information or documentation during the review process. Manufacturers must also ensure that their devices meet the essential principles of safety and performance outlined in the Technical Reference TR-004.
The conformity assessment body (CAB) is responsible for assessing the conformity of medical devices with the regulatory requirements. This thorough evaluation process helps ensure that only safe and effective devices reach the market.
How Long Is a Listing Valid for?
A Hong Kong Medical Device voluntary registration or listing is valid for five (5) years. You should submit a renewal application to the Medical Device Division at least 12 weeks before the expiry date. We would advise starting earlier than this 12-week period to ensure no disruption in market access.
The decision to register a medical device in Hong Kong, while currently voluntary, may become mandatory in the future. Hospitals may prefer devices that are registered, making this decision crucial for manufacturers and stakeholders.
The application processing time officially takes 12 weeks, but delays can extend this period to as long as 24 months. Understanding these timelines is essential when navigating the regulatory landscape.
Medical Device Classification System
Hong Kong applies the International Medical Device Regulators Forum (IMDRF) classification system i.e. four risk classes for medical devices. These are I, II, III and IV. Class I is the lowest risk class and Class IV represents high risk products.
At present, only Classes II, III, and IV can be listed. Despite this voluntary status, registered devices are preferred by the Hospital Authority for public hospital tenders.
The voluntary system for medical device registration in Hong Kong applies to medium- to high-risk medical devices and IVDs. While registration is voluntary, evidence of compliance with the Medical Device Administrative Control System (MDACS) is required for companies wishing to register, with significant emphasis on the need for local conformity assessment and quality system standards.
Why Should I List My Device if It Is Not Mandatory to Do So?
As of November 1, 2024, any procurement by public hospitals or clinics through Hong Kong’s Department of Health (DH) must be for MDACS listed medical devices. All quotes submitted to the DH must include a MDACS Listing number or have an assigned Application Number before the quotation closes, with already listed devices being given preference.
Accessing the Greater Bay Area and other Asian markets, including Hong Kong, offers significant opportunities for manufacturers. To stay competitive and ensure market access, manufacturers should apply for MDACS listing as soon as possible.
Effective regulatory control is essential for navigating device approval processes. As the risk associated with medical devices increases, so does the level of regulatory control that applies, making it crucial to understand the classification systems and their alignment with international guidelines.
Are There Other Advantages of a Hong Kong Listing?
Yes, a Hong Kong Listing can provide a strategic advantage for manufacturers looking to access mainland, through a staged process. Initially, it can give a strategic advantage in accessing the Greater Bay Area (GBA), which includes Guangdong, Hong Kong, and Macau, with a population of around 80 million people. Approvals from reference countries like the US, EU, and Australia can further enhance this advantage, as these approvals are often recognized and can facilitate the registration process in Hong Kong.
Additionally, while approval from the country of origin is not required for voluntary listing, having authorization from major markets can significantly enhance the registration process in Hong Kong.
Through a scheme known as the “GBA Connect Scheme”, medical devices, IVDs, and drugs that are urgently needed for clinical use and have no similar products already approved in China. Their use may be allowed in 71 (correct as of December 2025) designated hospitals in Shenzhen, Guangdong, Zhuhai, and other major cities.
Our Hong Kong Medical Device Registration / Listing Services
We guide you through every step of the Hong Kong Medical Device Registration or Listing process. We take care of compliance with MDACS requirements helping you through the whole process.
The guidelines provided for the expedited approval process establish clear timelines and classifications, ensuring applicants understand the necessary information and approvals.
- Hong Kong Listing
- Hong Kong Medical Device Listing Expedited Approval Route
- Greater Bay Area Approvals
- Receipt and reply to Supplementary Notices
- Change applications & listing renewals
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