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Goa FDA directs medical device cos to get manufacturing license for Class A & B medical devices

Shardul Nautiyal, Mumbai
Saturday, December 17, 2022, 08:00 Hrs  [IST]

The Goa Food & Drugs Administration has directed medical device manufacturers in the state to obtain license for manufacturing of Class A and Class B medical devices by visiting online medical device  portal https://cdscomdonline.gov.in.

Registration of medical devices will restrict the inflow of fake products in the Indian market. The Centre aims to keep a quality check on all medical devices available in the market through implementation of new Medical Device Rules – 2017 which will happen only after the completion of the registration process.

Licensing has been made compulsory for all Class A and Class B medical devices with effect from October 1, 2022 but registration process has been slow as it is a voluntary exercise to be implemented by the manufacturers, lament drug regulatory experts.

“Central Government through a Gazette Notification has notified that for manufacture of all Class A & Class B medical devices license will be mandatory under Medical Devices Rules 2017,” according to a notice from the Directorate of Food & Drugs Administration (FDA), Goa. Copy of the Gazette notification is uploaded on the official website of FDA www.dfda.goa.gov.in.

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 manufacturers of Class A & Class B medical devices are licensed by State Licensing Authority and manufacture of Class C & Class D medical devices are licensed by Central Licensing Authority (CLA) which is the Drugs Controller General of India (DCGI) from the Central Drugs Standard Control Organisation (CDSCO) office.


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