As a special administrative region of China, Hong Kong has its own medical device regulations, separate from the mainland. While Hong Kong had little legislative control over the import of medical devices in the past, recent changes to Hong Kong’s medical device registration system have led to stricter requirements.
If you are looking to import your medical device into Hong Kong, Pacific Bridge Medical can help you achieve regulatory compliance and access to Hong Kong’s medical market in an efficient and timely manner.
Click on the following questions to learn more about the regulatory process for Hong Kong medical device registration.
Which regulatory bodies in the Hong Kong government are responsible for medical device registration in Hong Kong?
- The Department of Health (DOH) is the regulator for pharmaceuticals and drugs, radioactive substances, and medical devices.
- Within the DOH, the Medical Device Control Office (MDCO) is responsible for approving medical devices in Hong Kong.
In Hong Kong, are medical devices required to be registered before they can be sold?
Hong Kong currently has no mandatory registration for medical devices, but manufacturers and importers can opt for voluntary registration of Class II, III, and IV devices under the Medical Device Administrative Control System (MDACS). The government intends to make the MDACS a mandatory system in the near future.
What are the advantages of registering for voluntary listing?
- According to the DOH’s advice, products registered under the voluntary system will be transferred directly to the regulation list without another dossier submission. If you are not on the voluntary list and mandatory registration is initiated, there will be a long line of companies trying to register their products at the same time, and this may affect your sales in Hong Kong.
- Hospitals and healthcare professionals are more likely to use listed devices.
- We recommend that medical device companies apply for Hong Kong’s voluntary list now.
What are the different regulatory classifications for medical devices?
- Class I: Low Risk (similar to Class 1 of the EU System)
- Class II: Medium Risk (similar to Class 2a of the EU System)
- Class III: Medium High Risk (similar to Class 2b of the EU System)
- Class IV: High Risk (similar to Class 3 of the EU System)
What does the registration pathway look like for each regulatory classification?
Voluntary registration for Class II, III, and IV devices require submitting a MDACS application form. The application questionnaire consists of the following parts:
- Part A: Manufacturer Information
- Part B: Local Responsible Person (LRP) Information
- Part C: Device Information
- Part D: Marketing Approvals and Essential Principals
The approval timeline ranges anywhere from 9-12 months.
What are the document requirements for registration?
- MDACS Form
- Instructions for Use (IFU)
- ISO 12485
- Summaries on available clinical data
- Test reports as required
- Other data requested by the MDCO
Is local testing (type testing/sample testing) required for registration?
No, local testing is not required for registration in Hong Kong.
Are clinical studies required for registration?
No, clinical studies are not required for registration in Hong Kong.
Is approval in the Country of Origin required for registration?
No, approval in the Country of Origin is not a requirement for registration in Hong Kong.
Are you interested in voluntarily registering your medical device in Hong Kong? Pacific Bridge Medical’s consultants will prepare your product for MDACS mandatory registration in order to speed your medical device past regulatory hurdles. Contact us now for a free consultation.
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