FDA Goa directs Medical Device Cos to get license for Class A & B

Licensing has been made compulsory for all Class A and Class B medical devices with effect from October 1, 2022

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FDA State Food and Drugs Administration
FDA

Last Updated on January 6, 2024 by The Health Master

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

Registration of medical devices will restrict the inflow of fake products into the Indian market.

The Centre aims to keep a quality check on all medical devices available in the market through the implementation of the 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 the 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 the manufacture of all Class A & Class B medical devices, a license will be mandatory under the Medical Devices Rules 2017,” as per the notification No. 102(E) dated February 11, 2020, according to a notice from the Directorate of Food & Drugs Administration (FDA), Goa.

A copy of the Gazette notification is uploaded on the official website of the FDA, www.dfda.goa.gov.in.

Under the Medical Devices Rules 2017, medical devices are classified based on the risk factor as follows:

  • Class A (low risk),
  • Class B (moderate risk),
  • Class C (moderately high risk),
  • Class D (high risk).

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

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