Medical Device and IVD Registration and Approval in Hong Kong

ANSWERED ON THIS PAGE: 

• What is the medical device registration process in Hong Kong? 
• How does Hong Kong classify medical devices and IVDs? 
• Is an in-country representative required for non-Hong Kong- based manufacturers? 

Medical device regulations 

Medical device and in vitro diagnostic (IVD) device regulation in Hong Kong falls under the purview of the Medical Device Division (MDD).   

Per the Legislative Council Panel on Health Services Proposed Regulatory Framework for Medical Devices, the government of Hong Kong plans to implement a regulatory framework for medical devices that will classify devices by risk according to the recommended classification scheme of the International Medical Device Regulators Forum (IMDRF). Subsequently, all devices will be subject to mandatory registration, except those in the lowest risk category. 

Companies that plan to register under the voluntary system must prove conformance with the Medical Device Administrative Control System (MDACS), which the MDD will review under the Department of Health. Currently, only medium- to high-risk medical devices — i.e., Class II/III/IV — are eligible for voluntary listing, and the MDD has published various guidance documents to assist manufacturers. Class I devices cannot be listed, even voluntarily. There are currently no official fees for medical device listing. 

Emergo has the expertise to help you navigate regulatory requirements and begin selling your device in Hong Kong. 

Registration routes in Hong Kong 

Class I medical devices and Class A IVD devices are not eligible for voluntary registration and listing under the MDACS. The steps to obtain a voluntary device listing for a Class II, III or IV device with approval from a reference -country are outlined below:  

1. Confirm your device’s classification. 
2. Appoint a Local Responsible Person (LRP) to serve as a liaison among users, manufacturers and the government. 
3. Compile the application and supporting documents and provide them to the LRP. 
4. The LRP submits the application dossier to the MDD for review. 
5. The MDD reviews the submission and may request additional clarification or documentation during the review. 
6. Upon favorable review, the MDD will issue a listing number and add the device to the List of Medical Devices database. The MDD offices issue hard copies of certificates.  
7. Begin commercialization. 
8. Fulfill post-market obligations. 

Medical device classification in Hong Kong 

The MDACS uses a four-tiered risk classification system based on the rules provided in TR-003 for medical devices and TR-006 for IVD devices, with increasing risk assigned to Classes I, II, III and IV, respectively, or Classes A, B, C and D, respectively, for IVD devices. Like most systems, regulatory control increases with increasing risk. The classification rules are derived from the IMDRF classification guidelines.  

The medical device classification therefore closely aligns with the EU Medical Device Directive 93/42/EEC classification system, so classification in Hong Kong will often reflect the EU MDD classification. However, there may be differences compared to the classification rules of the MDR 2017/745.  

Emergo can help your medical device company determine device classification before you register for regulatory approval. 

Let Emergo assist you with Hong Kong’s regulatory approval process 

With an office in Hong Kong, Emergo can assist you with your registration and interact with the local MDD on your behalf. Here’s how we can help: 

• Our team of expert consultants can efficiently register your devices and interact with the MDD on your behalf. 
• We can act as your LRP if you have no local office in the country or simply wish to outsource the regulatory functions of a local office. 
• We can help you access other medical device markets in Asia according to your business strategy. 
• Hong Kong is a transitioning medical market in Southeast Asia. Let Emergo help you access this market. 

With offices in Europe, the Middle East, North America and beyond, Emergo can help you start selling in Hong Kong and in markets around the world. Please contact us for more information on our medical device and IVD device registration services for Hong Kong. 

Frequently asked questions about Hong Kong 

Do I need an in-country representative? 
Companies without a local presence must appoint an LRP. The LRP must be “a legal person incorporated in Hong Kong, or a natural or legal person with a business registration in Hong Kong.” 

The LRP is the applicant for the device registration and is identified in the registration. The LRP also has post-market responsibilities that include adverse incident reporting, complaint handling and recalls. Emergo can act as your LRP. 

Do I need country of origin approval to be eligible for registration in Hong Kong? 
Approval in the country of origin is not required for voluntary listing under the MDACS. Note that manufacturers can bypass conformity assessment for products authorized in Australia, Canada, the EU, Japan or the U.S. Thus, we recommend obtaining authorization in one of these markets before pursuing voluntary registration in Hong Kong to fully capitalize on those authorizations.