HongKong MDD


HongKong Medical Device Registration

Hong Kong’s medical device market may be smaller compared to other famous Asian markets, but it’s an equally lucrative and expanding platform.Qualtech  is your ideal partner to for your foray into the HongKong medical device market for an easy and smooth registration process.

 

QT Services
 
 
 
 

Medical Device Registration

Our in – house experts are able to provide you with excellent professional service in preparing Submission dossiers liaising with MDD officers to get your devices registered in the HongKong.

 
 

Authorized Representation

As an in – country authorized representative (AR), Qualtech can hold a medical device registration license on behalf of foreign manufacturers looking to market medical devices in HongKong. This is in compliance with the law for a local establishment to be a license holder.

 

Registration with MDD

Medical Device Division (MDD) oversee all regulatory affairs pertaining to medical devices in HongKong, but it has not outlined any specific guidelines or regulations regarding importation, distribution or sale of devices. Compliance guidelines in Hong Kong, contained in the Medical Device Administrative Control System (MDACS), are based on Global Harmonization Task Force (GHTF) guidelines. A manufacturer who doesn’t have a registered establishment in Hong Kong and wants to apply for inclusion of a device into the List of Medical Devices should designate a Local Responsible Person (LRP).

Classification
 
 

 

Class A

Low risk device

No Certificate

Class B

Low-Moderate Risk

Listing Certificate

On counter submission

Class C

High-Moderate Risk

Listing Certificate

On counter submission

Class D

High Risk

Listing Certificate

On counter submission

Note: Currently only Class II, III and IV medical devices can be voluntarily listed on MDACS. Class I devices cannot be registered.

TECHNICAL REQUIREMENTS

Qualtech CLASS B CLASS C CLASS D
Essential Principles and Methods Yes Yes Yes
Summary of Design V&V Yes Yes Yes
Labeling and IFU Yes Yes Yes
Risk Assessment Yes Yes Yes
Physical Manufacturer Information Yes Yes Yes
Clinical Evidence Yes Yes Yes

Note: Kindly see the Guidance Notes for Listing Class II/III/IV Medical Devices issued in 2011 for more details.

 
Workflow
 
 

MDD Target Reviewing Turnaround Time

After successful internal evaluation of the submission dossier, our in – house experts will then submit it to the MDD and will be subjected to thorough evaluation. Below is a list of the turnaround times for different types of transactions involving product registration/notification.

  CLASS B CLASS C CLASS D
Primary Evaluation 14 14 14
Registration 84 84 84
Compliance Unlimited Unlimited Unlimited
  • Note:
  1. 1. It’s accounted as Working days.
  2. 2. The device shall get approval in US FDA, EU, Canada, Japan, Australia, China, and Korea.
  3. 3. The above stated working days do not include Conformity Assessment Body’s evaluation period.
Validity
 
 
  • Types of Certificates: Listing Certificate

  • Listing Certificate: 5 years

 
Tips
 
 
If MD is not mandatory need to be registered, should I apply for registration?

In HongKong, it’s not mandatory to register the medical device before go on local market. Why does some manufacturers still decide to register their products?

Sometimes the clinics or hospital prefer to use medical device approved by MDD. Therefore, medical device with MDD approval would be easier to sell in HK market.

Home-country marketing approval is not necessary, but marketing approval from one of the GHTF countries is mandatory for the device registration process.

 

For more information, please refer to the MDD’ official website or you may contact us for a free consultation.

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Official Website