Notice Regarding Classification Of Non-Modified Medical Devices ( IVD)

 

Health ministry has released a draft classification for non- notified medical devices for its efficient regulation. The Drugs Controller General of India responsible for Drug product registration in India, had notified every stakeholder as well as associations for required comments as well as suggestions for classification of those non-notified medical devices by October 3, 2020, for efficient regulation as per New Medical Device Rules. As per the notice, all suggestions have been effectively sought about the previous gazette notification that was published on February 11, 2020, which stipulates that all medical devices must be regulated in a phase-wise manner.

IVDs are classified into class A (low risk), class B (moderate risk), Class C (moderate-high risk) and Class D (high risk). For facilitating the whole procedure for classifying IVD medical devices, all devices are classified into 3 main categories like IVD analyzer, IVD instrument and IVD software and are scrutinized based on the classification that is followed an international and first schedule of MDR-2017.

Recently, DCGI has offered an advisory to all manufacturers to register on the CDSCO online portal. The process of registration will provide a registration number to all manufacturers that will serve as a quality management system benchmark. At present, only 25 manufacturers have ISO 13485 certification. To make sure all patients are under safety at all points of care, all medical experts have recommended that every medical device including IVDS must be confirmed by the Bureau of Indian Standards.

DCGI has thus issued an advisory to register on the online portal and obtain a certificate of conformity from any of the notified bodies of CDSCO. Manufacturers interested in applying for a BIS license must register themselves and submit their application online on the website of BIS.

Under different categories of devices based on risk classes, there are a different number of IVD devices. Manufacturers are required to check the list and register accordingly for effective management by the concerned authority.