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Last updated on : 24/04/2018
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MEDICAL DEVICES AND DIAGNOSTICS

Guidelines on Essential Principles for safety and performance of Medical DevicesNEW

FAQ on Grouping Guidelines issued under Medical Device Rules 2017NEW

Grouping Guidelines for  Medical Device Applications

Proposal invited for designation of Central Medical Device testing lab for Medical devices including In-Vitro Diagnostic medical Device under Medical Devices Rules, 2017

Frequently Asked Question on Medical Device Rule, 2017

Notice regarding Finalization of audit fee of Notified Bodies under Medical Devices Rules,2017

Workshop for MD & IVD manufacturers on 19.02.2018

Medical Device Rule 2017 - GSR 78(E) Dated- 31.01.2017

FAQ_IVD_MDR-2017

Classification of Medical devices and in Vitro diagnostic Medical devices under the provisions of the Medical Devices Rules 2017

List of Clarifications/NOCs Issue from 2011- Oct 2017

Medical Device Adverse Event reporting form

Report of the committee to examine the issues relating to the essentiality of coronary stents

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 

 Revised Pre-Screening checklist for acceptability of application of Medical  Device and Invitro Diagnostic w.e.f 01.07.2015 

 















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