JavaScript must be enabled in order for you to use the Site in standard view. However, it seems JavaScript is either disabled or not supported by your browser. To use standard view, enable JavaScript by changing your browser options.

Last Updated on : 11/08/2018
Grant of additional products & certificates like i.e. Market standing certificate, Non-conviction certificate and performance certificate etc. w.r.t. Medical Devices and In-vitro DiagnosticsNEW

Guidance on Performance Evaluation of In-vitro Diagnostic Medical DevicesNEW

The National Coordination Centre (NCC)-Materiovigilance Programme of India (MvPI) has released Draft Guidance Document for Medical Devices. This is a unique document which covers all the relevant information related to Medical Device under one umbrella. Guidance Document is now available to seek stakeholder’s comments till 01/09/2018 (30 calendar days

List of Clarifications/NOCs Issue from 2011-  2018

Quality Control testing of viral load monitoring kits for HIV, HCV and HBV-Reg

S.O. 2237(E)_Notification on Central Medical Device Testing Laboratory under MDR 2017

Applicability of IS/ISO 15197 2013 version regarding glucometer test strips

Notice regarding List of Notified Bodies registered with CDSCO under MDR,2017 regarding  dated 04.5.201

Guidelines on Essential Principles for safety and performance of Medical Devices

FAQ on Grouping Guidelines issued under Medical Device Rules 2017

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, 2018

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


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


 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 


Go back
Top page