Forms

Forms

(Note: The Medical Device Control Office has been renamed as the Medical Device Division with effect from 1 October 2019. Please refer to Contact Us page for updates in contact information and contact our office for enquiry, if necessary.)

Forms are available in pdf and/or Word formats:

Application for Inclusion on the List of Importers/ Distributors (MD-IP+D)
Application for Recognition (or Change of Scope of Recognition) Under the Conformity Assessment Body Recognition Scheme of the MDACS (CAB-AA)
PDF
Application for the Listing of In Vitro Diagnostic Medical Devices (IVDMD) (MD102)
PDF
Application for the Listing of Local Manufacturers (LM)
PDF
Application for the Listing of Class II/III/IV General Medical Devices (MD101)
PDF
Application Form for Certificate to National Medical Products Administration
Change Application Form for Listed Medical Devices (MD105)
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
Medical Device Adverse Event Report Form - for Medical Device Users
Post-Market Surveillance Report Form (MD108)
Renewal and Change Application Form for Listed Importers/Distributors (MD203)
Renewal / Change Form for Listed Local Manufacturers
Renewal Form for Listed Medical Devices
Supplementary Information Sheet for Medical Devices Procured by the Hospital Authority (HA)(MD111)
Takeover Form for Listed Medical Devices (MD110)
Update Information for Listed Traders and Conformity Assessment Bodies (CAB) under Medical Device Administrative Control System (MDACS)
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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.