Medical Devices Registration and Approval in Hong Kong
MEDICAL DEVICE REGULATION IN HONG KONG
There are no medical device regulations in Hong Kong. However, there are 2 agencies involved in the current requirements of medical device in Hong Kong, namely:
Hong Kong Medical Device Control Office (MDCO) under the Department of Health (DOH); and
Hong Kong Hospital Authority (HA)
MDCO has introduced the voluntary registration system for manufacturers and importers to submit their Class II, III, and IV devices under the Medical Device Administrative Control System (MDACS). This requirement will be mandatory when the bill is passed in the future. For now, both manufacturers and importers register devices through the voluntary registration to get their products in the system prior to the commencement of regulations.
Currently, there are many products listed in MDCO in which the health care institutions and professionals are more inclined to use listed medical devices.
MEDICAL DEVICE REGISTRATION AND APPROVAL IN HONG KONG
For the current voluntary product registration submission, medical devices are classified into 4 classes as follows:
Class I: Low Risk (similar to Class I and A in EU and IMDRF respectively);
Class II: Medium Risk (similar to Class IIa and B in EU and IMDRF respectively);
Class III: Medium-High Risk (similar to Class IIb in EU and IMDRF respectively); and
Class IV: High Risk (similar to Class III or D in EU and IMDRF respectively).
The application dossier consists of different parts of information:
Part A: Manufacturer Information;
Part B: Local Responsible Person (LRP) Information;
Part C: Device Information; and
Part D: Marketing Approvals and Essential Principles.
Upon product approval, the LRP is obligated in their LRP role which also includes the post-market reporting.
There are specific labeling requirements in Hong Kong. ARQon has shared on the Asian labeling requirements during the Global Medical Device Forum talk in Belgium. The talk was to explain the comparison between the new EU MDR and global.
Refer to the latest news for more Hong Kong updates.
APPLICATION FOR LISTING CLASS II/III/IV GENERAL MEDICAL DEVICES AND FORTHCOMING ENACTMENT OF REGULATION ON MEDICAL DEVICES IN 2019
The regulation on Medical Devices in Hong Kong commenced in 2004 on high risk Class IV general medical device through a voluntary listing system known as the Medical Device Administrative Control System (MDACS). The extension to cover risk classes of Class II and III general medical devices was established on 14 Nov 2005. For over 13 years now, the proposal to have a mandatory regulation system for Medical Device covering also in vitro Diagnostics will be put to the Legislative Council later this year (2019) and it is expected that the enactment of law and mandatory regulation for medical device will be realized by end 2019 or early 2020.
APPLICATION FOR LISTING CLASS B/C/D IN VITRO DIAGNOSTICS (IVD) MEDICAL DEVICES
In anticipation for the full regulation in 2019 on medical devices including in vitro diagnostic (IVD) medical devices, the Medical Device Control Office (MDCO) of the Department of Health in Hong Kong has on 11 Feb 2019 stepped up the listing application on Class D IVD to include Class B and Class C IVD medical devices.
APPLICATION FOR LISTING LOCAL RESPONSIBLE PERSON (LRP) FOR LISTING APPLICATION OF MEDICAL DEVICES
Since 2006, MDCO has implemented In anticipation for the full regulation in 2019 on medical devices including in vitro diagnostic (IVD) medical devices, the Medical Device Control Office (MDCO) of the Department of Health in Hong Kong has on 11 Feb 2019 stepped up the listing application on Class D IVD.
Example of Approval
Regulations & Guidance Documents: