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

303
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.

Procedure to obtain license for manufacturing of Medical Devices

Latest Notifications: Medical Devices

Classifications of Medical Devices under the provisions of MDR 2017

FAQs on Medical Devices Rules, 2017    

FAQs – on Blood Pressure Monitoring Devices

FAQs – on Blood Bags and its Testing

Medical Device Alert: Lists

Forms: Medical Devices

Schedules: Medical Devices

NABL 126: Specific criteria for calibration of Medical Devices

Bulk transfer of Blood and Blood Components: Procedure and Conditions

USFDA issues warning letter to Sun Pharma for Halol facility

IPC flags drug safety alert against Minoxidil

USFDA issues Form 483 with 8 observations to Jubilant

NPPA releases 5th list of draft ceiling prices for 69 formulations

DCOIWA to conduct workshops on Drugs & Medical Devices

US Court dismisses cancer linkage associated with Ranitidine

International drug racket busted in Hyderabad, two held

Drug alert: 83 out of 1487 samples declared as NSQ in November 20222

Latest Notifications regarding Pharmaceuticals

For informative videos on Medical Devices, click on the below YouTube icon:

YouTube Icon

For informative videos by The Health Master, click on the below YouTube icon:

YouTube Icon

For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:

YouTube Icon

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

YouTube Icon

For informative videos on consumer awareness, click on the below YouTube icon:

YouTube Icon
Telegram
WhatsApp
Facebook
LinkedIn
YouTube Icon
Google-news