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 (PMS)
Renewal and Change Application Form for Listed Importers/Distributors (MD203)
Renewal / Change Form for Listed Local Manufacturers
Renewal Form for Listed Medical Devices
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.