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State approvals / Tripura / Drugs Control Administration

Application for Manufacturing of Class A & B Medical Device

DepartmentDrugs Control Administration
TypeNew
StagePre-Operation
Time limit30 Days
FeeNo fee
AppliedApply on NSWS
Apply on National Single Window System

Documents to submit

#DocumentConditionRequired
1 Covering Letter — Required
2 Constitution of the Firm — Required
3 The Establishment / Site ownership / Tenancy Agreement — Required
4 Copy of duly notarized valid copies of Quality Certificate in respect of manufacturing site(s) If any If applicable
5 Copy of Certificate supporting Quality Management System (ISO: 13485) If any If applicable
6 Plant Master File from the Manufacturer as specified in Appendix 1 of Fourth Schedule of Medical Devices Rules — Required
7 Device Master File from the Manufacturer as specified in Appendix II (only for Medical Devices) of Fourth Schedule of Medical Device Rules — Required
8 Performance Evaluation Report of IVDs only — Required
9 Test License obtained for testing and generation of quality control data — Required
10 Undertaking signed stating that the manufacturing site is in compliance with provision of Fifth Schedule — Required
11 Fee Challan — Required
12 Legal Form — Required

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