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)
Application for the Listing of In-Vitro Diagnostic Medical Devices (IVDMD) (MD-IVD)
Application for the Listing of Local Manufacturers (LM)
Application for the Listing of Class II/III/IV General Medical Devices (MD-C2&3&4)
Application Form for Certificate to National Medical Products Administration
Change Form for Listed Medical Devices
Essential Principles Conformity Checklist (MD-CCL)
Essential Principles Conformity Checklist for In Vitro Diagnostic Medical Devices (MDIVD-CCL)
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
Takeover Form for Listed Medical Devices (MD110)
Trial Scheme for acceptance of marketing approval obtained from the Ministry of Food and Drug Safety - Application Form for the Listing of Class II/III/IV General Medical Devices
Trial Scheme for acceptance of marketing approval obtained from the National Medical Products Administration - Application Form for the Listing of In-Vitro Diagnostic Medical Devices (IVDMD)
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.