Hong Kong

Medical Device Registration 

Regulatory Landscape

In Hong Kong, the Department of Health (DOH) regulates the medical device industry. The regulatory framework includes comprehensive guidelines for product registration, clinical trials, quality management systems, and post-market surveillance. The DOH has launched a policy requiring all medical equipment purchased by the DOH to be registered on the voluntary list under the Medical Device Administrative Control System (MDACS). 

Medical Device Classification 

Medical Device Registration Process

The government will not charge fees for inclusion in the “Medical Device List” or application for device listing, but applicants or manufacturers must also take into account other fees required, such as fees charged by certification and assessment agencies, and certification of compliance with medical device safety and certification fees for basic principles of performance, etc.

The review and approval process for instrument listing applications is generally completed within 12 weeks after the applicant submits the application and all required supporting information (including label samples).

Note: The MDD review time can be accelerated after obtaining marketing approval documents from mainland China, Australia, Canada, the European Union, the United States, Japan, South Korea, Singapore and other countries.

Local Responsible Person (LRP) Responsibilities

1. Effective communication channels: The local responsible person is responsible for communicating with users, importers, distributors, the public and the government, and handling matters before and after the device is launched on the market.
2. Listing application: Since the local responsible person applies for listing of medical devices under the medical device administrative management system, he shall be responsible for all necessary contacts with the government in relation to the application.
3. Keeping supply records of medical devices: The local responsible person shall keep the latest list of importers, distributors and supply records of medical devices, including manufacturers, models, batch numbers, serial numbers and quantities, so as to be able to trace the information of the devices that have been imported and supplied in Hong Kong when necessary.
4. Handling complaints: The local responsible person must have a documented complaint handling procedure and provide the public with a telephone number, fax number and/or email address to listen to the opinions and complaints of users and the public.
5. Repair and maintenance arrangements: The local responsible person shall provide or arrange for others to provide preventive and fault repair services to users upon request, including calibration, supply of spare parts, and other services (if applicable).
6. Manage product recall and safety notifications: When a manufacturer or overseas authority issues a product recall and safety notification, the local person in charge must notify the Medical Device Division of the relevant details and the corresponding actions to be taken in Hong Kong as soon as possible within 10 days after the notification is issued.
7. Fulfill responsibilities related to medical devices and advertising, etc.

Partner with Accel

Experience the ease and efficiency of our Hong Kong medical device registration service. We specialize in navigating the complex regulatory landscape, ensuring your products meet the stringent standards set by the Department of Health (DOH). Our services include Local Responsible Person (LRP) representation, a crucial requirement for foreign manufacturers looking to enter the Hong Kong market. With our expertise, we streamline the approval process, reducing time-to-market, and maximizing your product’s potential in the Hong Kong market. Partner with us to unlock new opportunities in one of the world’s most rapidly evolving medical markets. Let us be your guide to success in the Hong Kong Medtech Market.