The Department of Health just officially announced that the Center for Medical Products Regulation (CMPR) is targeted to be established by the end of 2026. The Government is also targeting to introduce a bill for the statutory regulation of medical devices into the Legislative Council (LegCo) in 2026.
In Hong Kong, legislation specifically regulating the manufacture, import, distribution, supply, and use of medical devices is still pending enactment. In the interim, the Medical Device Administrative Control System (MDACS) has been implemented to facilitate the transition toward long-term statutory regulation. The system is administered by the Medical Device Division (MDD) under the Department of Health.
Note: The MDD was formerly known as the Medical Device Control Office (MDCO), established in July 2004. It was renamed the MDD on 1 October 2019.
Hong Kong’s current regulatory framework for medical devices is largely aligned with the recommendations of the International Medical Device Regulators Forum (IMDRF), formerly the Global Harmonization Task Force (GHTF).
The system monitors and coordinates the management of adverse incidents, safety alerts, and product recalls related to medical devices.
Foreign manufacturers have three options to register their medical devices in Hong Kong:
Establish a Legal Subsidiary in Hong Kong and designate it as the LRP.
Appoint a Local Importer or Distributor to act as the LRP.
Engage an Independent Third Party in Hong Kong to serve as the LRP.
Under Hong Kong’s MDACS, a medical device is defined as any instrument, apparatus, machine, material, software, or reagent for in vitro use, including related accessories, intended to be used for one or more of the following purposes in or on the human body, by means other than pharmacological, immunological, metabolic, or chemical action:
An In Vitro Diagnostic Medical Device (IVD) refers to any reagent, instrument, software, or system used to collect, prepare, or test specimens from the human body to diagnose disease, assess health status, or detect other conditions.
Medical devices are classified based on risk into four categories for both General Medical Devices (GMD) and In Vitro Diagnostic Medical Devices (IVDMD). The level of regulatory control is proportional to the risk level.
GMD Classification: I
IVDMD Classification: A
GMD Classification: II
IVDMD Classification: B
GMD Classification: III
IVDMD Classification: C
GMD Classification: IV
IVDMD Classification: D
Classification rules are detailed in:
If multiple classification rules apply, the rule assigning the device to the higher class takes precedence. The Medical Device Division (MDD) provides tools to help determine whether a product qualifies as a medical device and to identify its appropriate classification (link).
Both the legal manufacturer and the physical manufacturer of a medical device must be certified under ISO 13485. A valid ISO 13485 certificate must be submitted to the Medical Device Division (MDD) as part of the Medical Device Listing application under the MDACS.
The application consists of four parts:
To complete the application via the Medical Device Information System (MDIS), applicants should refer to:
According to GN-01 Guidance Notes for Overview of the Medical Device Administrative Control System, the listing process typically takes up to 12 weeks after submission of all required documentation. Listings are valid for five years, and renewal applications must be submitted at least 12 weeks to one year before the expiry date.
Depending on the nature, characteristics, and claims of a medical device, it may also fall under other regulatory frameworks, including:
Currently, the importation or sale of medical devices that contain pharmaceutical ingredients or emit ionizing radiation requires formal registration.
