Non-Notified Registration India – Amendment

Introduction: Non-Notified Registration India – Amendment

This article deals with Medical Device Amendment for Non-Notified Registration India. The Central Drugs Standard Control Organisation (CDSCO) is the Indian Advisory Body for Pharmaceuticals and Medical Devices wherein all Notified are regulated by them. The responsibility lies with the Drugs Controller General of India (DCGI) under the CDSCO for the Indian MDR. The CDSCO is responsible for the Indian MDR, Drug Regulation, Cosmetics, IVD’s and Medical Devices, control over the quality of Imported Devices, coordination of the activities of State Drug Control Organizations and providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act. As per CDSCO’S Rule effective April 1, 2020 all medical devices requires registrations. As per the rule, all Medical Devices are classified into two major classes 

1. Notified Medical Devices
2. Non-Notified Medical Devices

Until now, only Notified Medical Devices Required Registration in India. There are 37 classes of Medical Devices under the Notified Rule. However, as per the rule from April 1, 2020, all Medical Devices have been roped in for Registration. As per the gazette notification, effective April 1, 2020, the medical devices that fall under the following definition will be regulated as “drug” – 

All devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of ― (i) diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder; (ii) diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability; (iii) investigation, replacement or modification or support of the anatomy or of a physiological process; (iv) supporting or sustaining life; (v) disinfection of medical devices; and (vi) control of conception.

Any Medical Device Falling which does not fall under the 37 mentioned Notified Medical Device has to undergo the process of Non-Notified Product Registration. To know more about the process, please click her – https://morulaa.com/medical-device/indian-mdr-deadline-approaching-for-non-notified-medical-devices/

This article deals with the classifications of Non-Notified Medical Devices-Reg as mentioned by CDSCO. Ap per S.O 648(E) & G.S.R 102(E) all Medical Devices will be regulated in a phase manner. They have been classified as per the risk based approach in accordance with MDR-2017 Chapter II,Rule 4(3). The CDSCO is mainly dealing with Intended Use of Various Products & Regulatory Affairs for Indian Medical Devices. The CDSCO has classified the  Indian MDR, Appendix A based on the Intended Use, Risks Associated and Other Parameters Specified with the device. The General intended Use has been given by the CDSCO, however, Specific Intended Use can be given by the manufacturer. This list is dynamic and is subject to changes. The following is the table which has been published by the CDSCO for products dealing with Non Notified Medical Devices along with their Intended Use. 

Table for Non-Notified Registration India

How can Morulaa Help 

To obtain Regulatory Consultancy, contact Morulaa. We at Morulaa can help you learn more about your Medical Device Regulations. In order to comply with the 30th September, 2021 Deadline contact us by emailing us at admin@morulaa.com.

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