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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:
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Overview of the Medical Device Administrative
Control System (GN-01) |
[PDF ] |
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Guidance Notes for Listing Class
IV Medical Devices (GN-02) |
[PDF ] |
Application forms for listing Class IV medical devices:
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Application Form for Listing Class
IV Medical Devices (MD-C4) |
[PDF ][DOC ] |
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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.
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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.
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