Phase One of the Medical Device Administrative Control System (MDACS) was launched on 26 November 2004. If you are interested in listing your Class IV medical devices, please refer to the procedures and requirements detailed in the guidance documents below:

Guidance documents for the Medical Device Administrative Control System:

• Overview of the Medical Device Administrative Control System (GN-01) (PDF)
• Guidance Notes for Listing Class IV Medical Devices (GN-02) (PDF)

Application forms for listing Class IV medical devices:

• Application Form for Listing Class IV Medical Devices (MD-C4) (PDF / DOC)
• Essential Principles Conformity Checklist (MD-CCL) (PDF / DOC)

As the MDACS will be implemented by phases, only the applications for listing the Class IV medical devices will be accepted for the time being. Other applications for listing Classes II and III Medical Devices, Importers and Local Manufacturers will not be accepted until later phases and related announcements will be made in due course.

As a user and environmentally friendly measure, we intend to disseminate the latest progress of the Medical Device Administrative Control System (MDACS) and related information through emails. If you are interested, please fax the completed Application Form to us for processing. Fax numbers collected in the Application Form may be used for future communication in case of email communication breakdown.

• Subscription for email notification of latest development (PDF / DOC)

Should you want to make any amendments or remove your email from our dissemination list, please complete the same Application Form and fax back to us.