It contains various flowcharts which can help to understand some of the highlights of MDR application in India.

1. Short overview of
Medical DEVICE RULE 2017
CDSCO-MHFA
By-Rohit

2. Introduction
• The Central Drugs Standard Control Organization (CDSCO) under Directorate General
of Health Services in Ministry of Health and Family Welfare (MoHFW), Government
of India (GoI).
• It is the National Regulatory Authority (NRA) responsible for approval of
manufacturing, import, conduct of clinical trials, laying down standards, sale and
distribution of medical devices through enforcement and implementation of the
Medical Devices Rules, 2017
• Released through Gazette of India notification G.S.R. 78(E), dated 31st January
2017 by the MoHFW, GoI,
• Effective from 01.01.2018, under the Drugs and Cosmetics Act 1940
• Medical device rule 2017 consist of 12 chapter,8 schedule,40 medical device form

3. Medical Device Rules, 2017 Chapters

4. Different stages of MDR 2017
For regulatory approval; following point need to be consider
1) Classification of MD and IVD
2) Fees payable
3) Registration and function of notified bodies
4) Document required for approval of manufacturing and
import license
5) Implement Quality management system
6) Post approval major and minor changes
7) Clinical investigation requirement
8) Exemption

5. Process for obtaining manufacturing license for sale and distribution of medical device for Class A and
B(Blue chart) and class C and D (Grey chart)… SLA__ State Licensing Authority)
Form no 7 for manfact. License (50K) and form 8 for loan license

6. Import license procedure for Medical device for personal use

7. Import license procedure of MD for Govt use

8. Import licensing procedure for investigational MD

9. Import license in India under MDR 2017 rule
https://www.biotech.co.in/sites/default/files/2020-01/MDR17-%20Regulations.pdf

10. References
• MDR 17 – Regulation of Medical Devices” Building
Capabilities, Ensuring Quality and Patient Safety