Forms

Forms

The Medical Device Division has introduced a new Medical Device Information System (MDIS) on 2 April 2024, which will offer a one-stop e-service for the industry to submit online applications for listing of medical devices (MDs) and traders under the Medical Device Administrative Control System (MDACS), as well as to report safety alerts and adverse events related to MDs.

To facilitate smooth transition from paper-based to online submission of the application, the key dates of rollout of e-services of MDIS and ceasing to accept paper-based submissions are set out in the MDIS theme page.

Forms are available below:

Application for Inclusion on the List of Importers/ Distributors (MD-IP+D) (via MDIS)
WEB
Application for Recognition (or Change of Scope of Recognition) Under the Conformity Assessment Body Recognition Scheme of the MDACS (MD401)
PDF
Application for the Listing of In Vitro Diagnostic Medical Devices (IVDMD) (MD102) (via MDIS)
WEB
Application for the Listing of Local Manufacturers (LM) (via MDIS)
WEB
Application for the Listing of Class II/III/IV General Medical Devices (MD101) (via MDIS)
WEB
Application Form for Certificate to National Medical Products Administration (MD107)
PDF
Change Application Form for Listed Medical Devices (MD105)
PDF
Essential Principles Conformity Checklist (MD-CCL)
PDF
Essential Principles Conformity Checklist for In Vitro Diagnostic Medical Devices (MDIVD-CCL)
PDF
Medical Device Adverse Event Report Form - for Local Responsible Persons (AIR-LRP)
PDF WEB
Medical Device Adverse Event Report Form - for Medical Device Users (AIR-USER)
PDF WEB
Post-Market Surveillance Report Form (MD108)
PDF
Renewal and Change Application Form for Listed Importers/Distributors (MD203)
PDF
Renewal / Change Form for Listed Local Manufacturers (MD204)
PDF
Renewal Form for Listed Medical Devices (MD-Renewal)
PDF
Supplementary Information Sheet for Medical Devices Procured by the Hospital Authority (HA)(MD111)
PDF
Takeover Form for Listed Medical Devices (MD110)
PDF
Update Information for Listed Traders and Conformity Assessment Bodies (CAB) under Medical Device Administrative Control System (MDACS)
WEB
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Only submissions with duly completed application forms and required documents will be processed. Materials provided with any submission will not be returned.