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Discussion Forums on Proposed Framework for Statutory Regulation of Medical Devices

The Department of Health has launched the voluntary Medical Device Administrative Control System (MDACS) in November 2004 to pave way for future statutory regulation. Subsequent to the Regulatory Impact Assessment (RIA) completed in 2008, the Department has reviewed the RIA recommendations and the experience acquired from the MDACS to prepare the framework for statutory control of medical devices.

We would like to invite you to attend the captioned forums and provide us with your views and comments, in particular, on the following aspects:

1. The term "Authorized Representatives" is used to replace the existing term "Local Responsible Persons" under the existing MDACS to be in line with the recommendations of the Global Harmonization Task Force;
2. Distributors are required to register so that the distribution of medical devices from importers to retailers could be traceable; and
3. Import/export licenses are required for specified devices that are of high risk or may be subject to misuse so that the import and export control of these products are enhanced.

You may download the presentation materials, enrollment form for the forums and questionnaires for collecting comments. The deadline for submitting comments is 30 September 2010.

We look forward to receiving your views and comments so that we could work out the most suitable framework for Hong Kong.

Last Revision Date: 25 August 2010

Presentation
Enrollment form
Questionnaires
 

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Last Revision Date : 15 December 2012