LICENSE MANDATORY FOR MANUFACTURE OF MEDICAL DEVICES
August 11, 2022
Sravana 20, 1944
The Directorate of Food and Drugs Administration has informed that Central Government vide Gazette Notification GSR 102(E) dated 11/02/2020; has notified for manufacture of all Class A and Class B medical devices license will be mandatory under Medical Devices Rules 2017 with effect from October 1, 2022. The Gazette notification is available on www.dfda.goa.gov.in.
The term medical device means any device intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals.
Further, Central Government vide Notification No. S.O. 648(E) dated 11/02/2020 has specified the following devices intended for use in human beings or animals as drugs with effect from the April 1, 2020, namely: All devices including 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 assist in its intended function by such means for one or more of the specific purposes of : (a) Diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder (b) Diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability (c) Investigation, replacement or modification or support of the anatomy or of a physiological process (d) Supporting or sustaining life (e) Disinfection of medical devices and (f) Control of conception.
Under the Medical Devices Rules 2017, the medical devices are classified based on the risk factor as Class A (low risk), Class B (moderate risk), Class C (moderate high risk) and Class D (high risk). Out of the above manufacturers of Class A and Class B medical devices are licensed by State Licensing Authority and manufacture of Class C and Class D medical devices are licensed by Central Licensing Authority.
All the concerned manufacturers are requested to obtain license for manufacturing of Class A and Class B medical devices by visiting online medical device portal https://cdscomdonline.gov.in, as informed by the Department of Information and Publicity.