Chapter 1 Hong Kong Administration

1. Hong Kong MDACS

The Medical Device Division (MDD), formerly known as Medical Device Control Office (MDCO), is responsible for the administrative matters of medical device. There is a unique administrative system for medical devices in Hong Kong, namely MDACS (Medical Device Administrative Control System).

2. Administrative Regulation

International Medical Device Regulators Forum, IMDRF

3. Risk Level Classification

With reference to the medical device classification principles proposed by the International Medical Device Regulators Forum (IMDRF), medical devices (including general medical devices and in vitro diagnostic medical devices (IVDMDs)) are classified into four (4) categories based on the level of risk associated with their intended use. Only Class II, III and IV medical devices and Class B, C and D in vitro diagnostic devices can apply for listing in Hong Kong, while MDD will not accept listing applications for the lowest risk level Class I medical devices and Class A in vitro diagnostic devices. 

MD-Medical Device

IVD- In Vitro Diagnostic

The methods for determining the classification of product risk levels are as follows:

Method 1: Refer to the classification rules of "TR-003 Classification of General Medical Devices" and "TR-006 Classification of In Vitro Diagnostic Medical Devices (IVDMDs)", and determine the product risk level according to the classification rules.

Method 2: Use the Risk Level Decision tool on the official website, Department of Health | Medical Device Division - General Medical Device Classification Program

Method 3: Use the Hong Kong medical equipment list database, Department of Health | Medical Device Division - The List of Medical Devices

 https://www.mdd.gov.hk/sc/mdacs/search-database/list-md/index.html to check the risk level of similar products.

4. Materials required for registration

Prepare registration documents in accordance with the "TR-002 Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED) ". All application materials are required to be filled out in Chinese and English and submit application to the Medical Device Administrative Control System MDACS (MD-C2&3&4 Form for medical devices, MD-IVD form for IVD).

Required documents include:

CE certificate or 510K letter

Proof of conformity of quality management system, such as ISO 13485 certificate

Labeling and user instructions, complied with the TR-005 Additional Medical Device Labelling Requirements

Post-market process

Test reports of International Standards and clinical data (if applicable)

Prepare essential principles checklist in accordance with TR-004 (IVDs performance evaluation report)

For details, please refer to the guidelines "GN-02 Guidance Notes for Listing Class II, III & IV General Medical Devices " and "GN-06 Guidance Notes for Listing Class B, C and D In Vitro Diagnostic Medical Device ".

5. Registration Language

English or traditional Chinese.

Chapter 2 Registration Flow | Cycle

1. Registration Flow

2. Registration Cycle

Complete the list within 12 weeks after the submission of the application and all required supporting information (including sample label).

Chapter 3 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).

Chapter 4 Hong Kong Listing Template