Regulation/Guidelines

CDSCO Releases Notice For The Online Application Of Certificates Of Notified Devices

  • 18th September, 2020
CDSCO releases notice for the online application of certificates of Notified Devices

Presently in India, only notified medical devices are regulated as Drugs under the Drugs and Cosmetics Act 1940 and Rules in 1945. The Central Drugs Standards Control Organization (CDSCO) streamlined the process for submission of application for the issue of free sale certificate, market standing certificate, and non-conviction certificate of notified medical devices in India. This move is to guide Indian manufacturers or importers of medical devices for submission of application for obtaining Free sale certificate, Market Standing or Non-Conviction Certificate of Notified Medical Devices. This is applicable to those medical device importers or manufacturers in India who have valid manufacturing license or import license and want to obtain Market Standing or Non-Conviction Certificate of Notified Medical Devices. The notification came on 3rd September 2020.

An online application shall be made to the Central Licensing Authority (CDSCO) for notified medical devices by the manufacturer, having a valid license of manufacturing and sale or for distribution of notified Medical Devices. Earlier it was offline. Now, the applicants seeking permission can log in into https://cdscomdonline.gov.in/ and need to fill the checklist. The checklist is available in the online system for the medical devices portal.

These applications are granted by either the Central or State Authority, whoever has granted the license for the notified devices. The deadline for the hard copy or the offline submission of the applications is till September 30, 2020.

References:

  1. Available at: https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf- documents/medical-device/Guidancfreesale19.pdf .Accessed on 8 th September, 2020.
  2. Online Application for Free Sale certificate Market standing certificate and Non-conviction certificate of Notified Medical Devices. Available at: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_ division.jsp?num_id=NjQ0OA== .Accessed on 8 th September, 2020.
  3. Available at: https://cdscomdonline.gov.in/ . Accessed on 8 th September, 2020.