Hong Kong Approval Process for Medical Devices

The Medical Device Control Office (MDCO) medical device approval process explained

Registration of medical devices in Hong Kong is overseen by the Medical Device Control Office (MDCO). The process is currently voluntary,* but is intended as a phase-in of mandatory registration. The MDCO has set up the Medical Device Administrative Control System (MDACS) to facilitate the transition.**

Classify your device according to Classification Rules for Medical Devices. Typically the classification of your device matches classification in the European Union (EU). Foreign manufacturers will be able to leverage their prior authorizations in Australia, Canada, the EU, Japan, or the USA. Class I devices have no registration process and cannot be registered (even voluntarily). You may import Class I devices immediately. All instructions below will reference the process for Classes II, III and IV devices.

Step 1
Appoint a local company to act as your Local Responsible Person (LRP). The LRP will be responsible for coordinating your application and submission, as well as post-market vigilance activities.

Step 2
Obtain proof of marketing authorization from from Australia, Canada, Europe, Japan or the USA. Most companies supply a copy of their CE certificate or US FDA 510(k) letter as proof of compliance.

Step 3
Prepare MDACS application (form GN-05). Required documents include: CE Certificate or 510(k) letter, proof of Quality Management System compliance (e.g., ISO 13485 certificate), labelling and Instructions for Use (IFU),*** post-market procedures, international test reports and clinical data (if applicable), and Essential Principles Checklist. Documents should be provided in English or Chinese, or must be accompanied by an English or Chinese translation..

Step 4
Appoint an authorized importer located in Hong Kong.

Step 5
Your LRP submits the application to the MDCO.

Step 6
MDCO reviews application and may request additional documentation or clarification. LRP must provide any responses to MDCO inquiries in a timely manner.

Step 7
Upon approval, device is assigned a Hong Kong Medical Device number, and listed in MDCO database. Approval is valid for 5 years. LRP must submit application for continuation of the listing to the MDCO at least 3 months prior to expiration.

Step 8
You may now begin marketing your device in Hong Kong.

* Though the decision to register devices in Hong Kong is voluntary, both private and government hospitals generally prefer the MDCO listing number to show that the device is approved. Manufacturers who intend to sell to hospitals are encouraged to register.

** The voluntary registration process is intended to alleviate some of the expected rush of applications when the process becomes mandatory. There are no official fees during the voluntary registration process and the registrations will be honored when registrations are required..

*** Labelling and IFU must be submitted in English, however if your device is to be used by consumers, copies must also be submitted in Chinese.

This is a simplified overview of the process. The Hong Kong MDCO will likely audit your submission and request more documents, which will add time to your approval.

Chart updated: 23/05/2017