Hong Kong Medical Device Regulations

Entire conformity assessment route or Abridged route

Choose your regulatory pathway

Approval in the country of origin is not required for voluntary listing under the MDACS. Manufacturers may have two routes to get listed. One is to go through the abridged route, and another is to pass the conformity assessment route. The abridged route is applicable for products already approved in mainland China, Australia, Canada, the EU, Japan, or the U.S. Full conformity assessment route means that the medical device manufacturer shall conduct conformity assessment and provide objective evidence of safety, performance, benefits, and risks to prove product’s safety and performance. Such assessment shall be performed before and after a medical device is placed on the market, and active post-market surveillance shall be maintained.  The assessment process shall meet the MDACS requirements, and both the process and conclusions are subject to further review by the Conformity Assessment Body (CAB).

Although listing with MDACS is not mandatory, manufacturers may enjoy the benefit of an easier market launch to hospitals and clinics if they choose to list. Since 1 October 2022, DoH has been implementing a pilot run of a new requirement on the procurement of Medical Devices (MD). Under the pilot run, certain MDs (for example, condoms, lubricants, blood glucose meters, and blood glucose strips) being purchased for use in public hospitals shall preferably be listed under MDACS when going through the procurement process. 

Medical Device Regulation Hong Kong 

Medical device classification in Hong Kong

Medical devices are classified into four classes (I, II, III, and IV) according to the risk level associated with their intended use in Hong Kong: class I (low-risk and Animal Medical Devices), class II (Low-moderate risk), class III (Moderate-high risk), and class IV (High risk).

For general medical devices, the actual classification of each device depends on one or several factors, such as the duration of the device's contact with the body, the degree of invasiveness, whether the device delivers medicines or energy to the patient, whether it is intended to have a biological effect on the patient, and local versus systematic effects (e.g., conventional versus absorbable sutures). These factors may, alone or in combination, affect the intended device’s final classification.

For in vitro diagnostic devices, classification depends on the expertise of the intended user, the importance of the information to the diagnosis, and the impact of the result on the individual and public health. IVDs have been divided into classes A, B, C, and D.

Detailed classification per each product group can be identified in the below link:

Hong Kong Medical Device Representation 

Local Representative 

A Local Responsible Person (LPR) is required to import devices into the HK market. LRP needs to provide the information below to be listed with authority. A foreign manufacturer must appoint an LRP if they want to supply devices in Hong Kong. The LRP must be a legal person incorporated in Hong Kong or a natural or legal person with business registration in Hong Kong. This could be the local distributor, but appointing an independent third party gets more control of registration and provides more flexibility in changing distributors or appointing multiple distributors for better market penetration.
The approved LRPs are listed on the MDD website and have access to the public through the Department of Health | Medical Device Division - The List of Local Responsible Persons (LRP) (mdd.gov.hk).  LRP application needs to provide:

• Valid Business Registration Certificate
• Designation Letter issued by the manufacturer
• Set of documented procedures

The application for including LRP needs to be made together with the general medical device or in-vitro diagnostic device listing application.
For details, please refer to Overview of the Medical Device Administrative Control System

Hong Kong Medical Device Registrations

Registration Routes in Hong Kong

1. Determine the proper classification of the intended device.
2.  Determine the approved country outside of Hong Kong. 
   If the intended device has already obtained approval in the reference countries, such as the US, European Union, Canada, Japan, Australia, Korea, or mainland China, it should undergo the full conformity assessment route. 
3.  Designate a Local Responsible Person (LRP) as an agent/facilitator between users, manufacturers, and the local government.
4.  Collect and compile the application dossier based on the submission checklist requirement per document.
5.  LRP submits the application dossier to MDD for assessment.
6.  MDD acknowledges the application and evaluates the submission dossier.
   MDD may issue deficiency letters, and supplementary documents may be requested during evaluation.
7.  Once the assessment has been finished and approved, MDD will assign a listing number and list the intended device in the Medical Devices database. MDD offices will distribute a hard copy of the certificate with the assigned listing number to the designated LRP.
8.  Manufacturers may start the distribution activities.
9.  Fulfill post-market duties and responsibilities as required.

The listing is valid for 5 years. LRP shall apply for the renewal at least 3 months before the validity date via MDACS.