Hong Kong’s Department of Health (DH) currently has a voluntary registration system under the Medical Device Administration Control (MDACS). DH is currently drafting legislations based on the feedback they have received so far on this MDACS system. In this proposed legislation, all medical devices would need to be registered with the DH except for certain medical device groups, including those to be used for clinical trials.
For this latter group, the Director of Health will issue a Certificate for Clinical Trial to legally allow the medical device to be used in a clinical trial. The Medical Device Control Office (MDCO) of Hong Kong has just published on their website a guidance document for applicants interested in applying for a Certificate for Clinical Trial on Medical Device. At this stage, this application process is voluntary.
To determine if clinical trials are required for the medical device, the manufacturer should follow the following steps, according to the MDCO released document:
- Identify the Essential Principles relevant to the device in question
- Identify the clinical data necessary to address residual risks after risk control measures have been taken
- Perform a thorough clinical evaluation to identify existing sources of clinical data required
The draft regulations also list the main reasons for conducting the clinical trial, making sure that the trial is necessary, designed and conducted properly, ethical, follows proper risk management procedures, and complies with all relevant legal and regulatory requirements.
Applications can drop off forms to the MDCO office or mail the forms. The application should contain the following:
- Completed application form
- Completed clinical trial checklist
- Details of the medical device
- Copy of clinical trial protocol
- Letter from principal investigator (PI) confirming involvement in trial
- CV of the PI
- Documentary evidence that trial has been approved by research ethics committee of the institution in which it is to be conducted
- Copies of consent forms of the clinical trial participants
- In case a Certificate for Clinical Trial on Medical Device was issued previously but has expired/will soon expire, a copy of the previous Certificate(s) for Clinical Trials on medical Device
Reasons for not receiving a Certificate include examples such as the device not satisfying the relevant Essential Principles or that the clinical trial is suspected to not be subject to proper controls or there is inadequate/incomplete pre-clinical or animal data in order to make it reasonable for clinical testing to start.
Any amendments or changes to the trial need to be notified to the DH. In addition, all devices must have the words “exclusively for clinical trial” on them. Serious adverse incidents that arise from the clinical trial such as death, life threatening illness, etc. also need to be reported within ten days to the DH.
A progress report needs to be submitted on a yearly basis during the clinical trial. At the end of the trial, the certificate holder needs to submit a final report to the DH.