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(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 Distributors (MD-TREG) PDF doc
 
Application for Inclusion on the List of Importers/ Distributors (MD-IP+D) (Apr 2018 Edition) PDF doc
 
Application for Recognition (or Change of Scope of Recognition) Under the Conformity Assessment Body Recognition Scheme of the MDACS (CAB-AA) PDF doc
 
Application for the Listing of In-Vitro Diagnostic Medical Devices (IVDMD) (MD-IVD) (2019 Edition) PDF
doc
 
Application for the Listing of Local Manufacturers (LM) PDF doc
 
Application for the Listing of Class II/III/IV General Medical Devices (MD-C2&3&4) (Jul 2011 Edition) PDF doc
 
Application Form for Certificate to National Medical Products Administration doc
 
Change Form for Listed Medical Devices doc
 
Essential Principles Conformity Checklist (MD-CCL) (Jul 2011 Edition) PDF doc
 
Essential Principles Conformity Checklist for In Vitro Diagnostic Medical Devices (MDIVD-CCL) (2019 Edition) PDF
doc
 
Medical Device Adverse Incident Report Form for use by Local Responsible Persons PDF
doc
 
Medical Device Adverse Incident Report Form for use by Medical Device Users PDF doc
 
Renewal / Change Form for Listed Distributors doc
 
Renewal / Change Form for Listed Importers doc
 
Renewal / Change Form for Listed Local Manufacturers doc
 
Renewal Form for Listed Medical Devices PDF
 
Trial Scheme for acceptance of marketing approval obtained from the National Medical Products Administration or the Ministry of Food and Drug Safety - Application Form for the Listing of Class II/III/IV General Medical Devices doc
 
Trial Scheme for Expedited Approval of Class II/III/IV General Medical Device Listing Applications – Declaration Form doc
 
Trial Scheme for Expedited Approval of Class II/III/IV General Medical Device Listing Applications – Sample layout of device profile PDF
 


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Last Revision Date : 22 January 2020