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Draft Notification on Medical Devices Rules,17oct 2016
Medical Device Adverse Event reporting form
Report of the committee to examine the issues relating to the essentiality of coronary stents
Draft copy of Medical Devices Rules, 2016
GSR 640 (E) dated 29.06.2016 regarding Schedule - MIII - Requirement of QMS for Medical Devices
Acceptance Criteria for test and Examination of Blood Glucose Test Trips and Analyzer based glucose reagent
Minutes of the Meeting held on 05.12.2015
Guidance document on application for grant of licence in Form-28 for manufacture of Medical Devices in India Under CLAA Scheme
Medical Device Licensed Manufacturing units in Various State of India
Organogram of Medical Device Division
Other Related Guidelines/Clarification
Import Registration Certificates for Medical Devices issued
List of Licensed indigenous Manufacturers of Medical Devices
List of Notified Medical Devices
Medical Device Advisory Committe (MDAC)
General Formats - Medical device
Prescreening / Checklist
Regulatory Guidance
Non- Compliance observed During Review Process of application for Registration & Import Licenses of Medical Devices
Critical Diagnostics & Blood Products
In- Vitro Diagnostic Minutes
List of Diagnostic Kits for Blood Bank
Scanned Copies
Frequently asked Question on registration and import of medical devices in India
Frequently Asked question in Vitro Diagnostic IVD Devices
Legislation
Product Recalls and Alerts
Action Taken by O/o DCG(I) Against the Applicants/ Manufacturer/ Importers
IVD Office Order
Revised Schedule MIII For Finalized by sub committee of DTAB