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Administration of Hong Kong China

The regulation of medical devices in Hong Kong is overseen by the Medical Devices Division (formerly known as the Medical Devices Control Office), which has established a unique regulatory framework known as the MDACS (Medical Device Administrative Control System), specifically designed for the regulation of medical devices.

Regulatory Authority website link:https://www.mdd.gov.hk/tc/home/index.html

Database link: https://www.mdd.gov.hk/tc/mdacs/search-database/list-md/index.html?page=list&page_no=1&page_size=10&stype=make&search=&keyword_cover=exact&search_value=all

Administrative Regulation

International Medical Device Regulators Forum (IMDRF)

Risk Level Classification

Hong Kong follows the classification principles of the International Medical Device Regulators Forum (IMDRF) to classify medical devices (including general medical devices and in vitro diagnostic medical devices (IVDMDs)) according to the level of risk associated with their intended use:

General medical devices (MD) are divided into 4 classes, with risk levels ranging from low to high: Class I, II, III, and IV;
In vitro diagnostic medical devices (IVD) are classified into 4 classes, with risk levels ranging from low to high: Classes A, B, C, and D.

Only Class II, III, and IV general medical devices and Class B, C, and D in vitro diagnostic medical devices are eligible for Hong Kong listing. Class I general medical devices and Class A in vitro diagnostic medical devices are not accepted for listing due to their lowest risk levels.

Methods for determining product risk class:

① Determine the risk class by referring to the classification rules in “TR-003 Classification of General Medical Devices” and “TR-006 Classification of In Vitro Diagnostic Devices”;

② Determine the risk class using the risk classification decision-making tool on the official website;

General Medical Device Classification Procedure

In Vitro Diagnostic Medical Device Classification Procedure

③ Consult the Hong Kong Medical Device Listing Database (Medical Device List) to determine the classification of similar products.

Essential Entry Requirements

(1) Applications must be submitted by a local Hong Kong manufacturer or a Local Responsible Person (LRP);

(2) The LRP must be a Hong Kong-registered legal entity or a natural person/legal entity holding a Hong Kong Business Registration Certificate;

(3) Non-Hong Kong manufacturers must provide: a Letter of Authorization signed by the manufacturer appointing the LRP + the LRP’s valid Hong Kong Business Registration Certificate (Medical Devices Section).

Documents Required for Registration

Documents must be prepared in accordance with the “TR-002 Summary of Technical Documentation Demonstrating Compliance with the Basic Principles of Safety and Performance of Medical Devices.” All application materials must be completed in both Chinese and English, and the corresponding application forms must be submitted to MDACS (use Forms MD-C2, 3, and 4 for medical devices; use Form MD-IVD for IVDs).

List of Required Documents:

CE Certificate or 510(k) Letter

Proof of quality management system compliance, such as an ISO 13485 certificate

Labeling and instructions for use, which must comply with “TR-005 Additional Requirements for Medical Device Labeling”

Post-market procedures

International test reports and clinical data (if applicable)

Checklist prepared in accordance with TR-004 (IVDs must additionally provide a performance evaluation report)

For specific guidance, please refer to: “GN-02 Guidelines for the Listing of Class II, III, and IV General Medical Devices” and “GN-06 Guidelines for the Listing of Class B, C, and D In Vitro Diagnostic Medical Devices.”

Registration Language

English or traditional Chinese.

Registration Process, Timeline, and Official Fees

Registration Timeline: Listing is completed within 12 weeks after submission of the application and all required supporting documents (including label samples).

Official Fees:

Listing on the Hong Kong MDACS is free of charge; there are no official fees. Costs are incurred only for LRP maintenance and third-party services.

七、FAQ

Q: Is it necessary to conduct clinical trials in Hong Kong for Hong Kong Medical Device Listing?

A: At present, there is no specific legislation to regulate clinical research on medical devices in Hong Kong. But that doesn't mean manufacturers don't need to conduct clinical studies.

Q: Do medical devices have to have a Local Responsible Person (LRP) in Hong Kong?

A: Manufacturers who intend to apply for the inclusion of devices in the Medical Device List without a registered business address in Hong Kong are required to appoint a Local Responsible Person (LRP) before making the application.

Q: What is the validity period of listed medical devices in Hong Kong? How to renew?

A: The local responsible person should submit an application for renewal of the listed medical device to the Medical Device Division at least 12 weeks to 1 year (both days inclusive) in advance before the expiry of the 5-year validity period. The renewal application must reach the Medical Devices Division within the above period, otherwise the Medical Devices Division will not process the renewal application.

Q: What is a delisted medical device? Under what cases will a medical device be delisted?

A: The Department of Health may, at its discretion, remove a device permanently or temporarily from the List of Medical Devices under the following cases:

① The Department of Health considers it necessary to remove the device from the list based on public health or safety reasons, if the manufacturer or the local responsible person fails to handle or properly deal with the risk posed by the device; or

② The manufacturer or the local responsible person fails to comply with the requirements of the Medical Device Administrative Control System or any approval listing condition; or

③ Failure of the manufacturer or the local responsible person to fully comply with the Department of Health's instructions to withdraw unsubstantiated claims from the publicity; or

④ The manufacturer or the local responsible person has been liquidated or ceases to exist;

⑤ The manufacturer or local responsible person in charge to request de-listing.

Q: Does medical device registration in Hong Kong require country of origin registration?

A: Country of origin registration is not a prerequisite for registration in Hong Kong, but registration in Hong Kong can be accelerated if you have a national registration certificate from any of the five founding members of the International Medical Device Regulators Forum (IMDRF) (EU, Australia, Canada, Japan and the United States).

八、Hong Kong Listing Template

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