India Medical Device Regulations

Agency
All medical devices are regulated by by the Drug Controller General of India (DCGI) within the Central Drugs Standard Control Organization (CDSCO); part of the Ministry of Health and Family Welfare (MHFW)
Medical Device Definition
"medical device" means,- (A) an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may be assisted in its intended function by such means for one or more of the specific purposes of,- (i) diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder; or (ii) diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability; or (iii) investigation, replacement or modification or support of the anatomy or of a physiological process; or (iv) supporting or sustaining life; or (v) disinfection of medical devices; or (vi) control of conception;
Classification of Medical Device
International Classification Examples Risk Level Type of regulation
Class A Thermometers, tongue depressors Low License not required but voluntarily applied to be licensed by State Licensing Authorities (SLA)
Class B Hypodermic needles, suction equipment Low Moderate Approval by the SLAs
Class C Lung ventilator, bone fixation Moderate High Approval by Central Licensing Authority (CLA)
Class D Heart valves, implantable devices High
Premarket Approval Process *
Class A Class B Class C Class D
Self-regulation Approval by SLA Approval by CLA
Application for registration (appoint an authorized Indian agent)
Registration certificate issued by CDSCO
Application for import license
Import License issued by CDSCO
Notes
  • New Medical Device rule published in October, 17, 2016
  • Device registration do not expire but keep paying the fee every 5 years
  • Already notified medical devices marketed in India before in time to the starting of these rules shall continue to be marketed as before till the expiry of 18 months or the current validity of the license from the beginning of these rules
  • A license shall be granted if the medical device is having free sale certificate (FSC) issued from the national regulatory authority or any other competent authority of any of the countries (Australia, Canada, Japan, European Union Countries, or United States of America)

* See appendix 1 for details

Appendix 1

a) Manufacturing License of Medical Devices

For an application for a license to manufacture for distribution/sale of Class A & B devices, the application should be made online in Form MD- 3 or Form MD- 4 (for loan license) along with a fee. The license will be obtained under Form MD-5 or Form MD- 6 (for loan license).

For an application for manufacture for distribution/sale of Class C & D devices, the application should be made online in Form MD- 7 or Form MD-8 (for loan license) along with a fee. The license will be obtained under Form MD-9 or Form MD- 10 (for loan license).

b) Medical Devices

An application should be made online to the Central Licensing Authority (CLA) under Form MD- 14 for obtaining a license to import for sale or distribution via an authorized agent already possessing a license for manufacture for sale/distribution of medical devices or a wholesale license for sale/distribution of medical devices.

If the registration is compliant, the license will be issued under Form MD-15.


Source: CDSCO site