Till now in India only Notified Medical Devices are under the regulation of Drugs and Cosmetics Act 1940 and Rules in 1945 as Drugs. But CDSCO or Central Drugs Standards Control Organization has streamlined the application procedure for issuing free sale certificate, market standard certificate as well as a non-conviction certificate of the notified medical devices in India. This movement has been undertaken for guiding the Indian manufacturers or the importers of the medical devices for submission of application for obtaining those certificates.
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As per the notification, it is applicable only for those medical device manufacturers or the importers present in India having a valid manufacturing license or the drugs import license and wish to obtain a Market Standing Certificate or Non-Conviction Certificate of the notified medical devices in India. This notification was released on 30th September 2020.
As per the notification, an online application will be sent to CDSCO for notified medical devices by the manufacturer possessing a valid license of manufacture as well as sale or distribution of the notified medical devices. Previously it was made offline but now all applicants can seek permission online by logging into cdscomdonline.gov.in and are required to fill up the checklist. The whole checklist is present in the online system of the medical devices portal.
These applications will obtain approval either by the central or the state authority, whoever has granted the required license for the devices. The last date for submitting a hard copy of the application or the offline submissions was September 30, 2020. After that no more offline submissions are being accepted.
CDSCO further had issued a proper guidance document on the free sale certificate of the notified medical devices to offer guidance to all Indian manufacturers for submitting applications for free sale certificates to CDSCO.
This is applicable for those manufacturers of the medical devices in India who possess a valid manufacturing license and keep an intent to receive a Free Sale Certificate for export of Class A, B and Class C, D medical devices.
Thus, we can say that with online submission the process has become easier as well as faster for obtaining the required certificates of notified devices.
This post first appeared on Amendments Made In Medical Device Rules For NABL Accreditation, please read the originial post: here
