CDSCO classification for medical devices Risk-based Classifications

The CDSCO classifications of medical devices govern alongside the regulatory approval and registration by the CDSCO is under the DCGI. Every single medical device in India pursues a regulatory framework that depends on the drug guidelines under the Drug and Cosmetics Act (1940) and Drugs and Cosmetics runs under 1945.CDSCO classification for medical devices has a set of risk classifications for numerous products planned for notification and guideline as medical devices. The Health Ministry of India has distributed new medical devices and IVD guidelines to improve the nation’s Drugs and Cosmetics Act for making viable regulations.

CDCSO manages the affairs relating to the classification of medical devices. The same authority operates under the purview of the Drug Controller General of India. The Drugs and Cosmetic Act 1940 and Drugs and Cosmetic Rules 1945 constitute the regulatory framework for all medical devices in India. The Health Ministry of India has released the new medical devices and IVD regulations to improve the effectiveness of the Drugs and Cosmetic Act 1940. The said regulations came to effect on Jan 1, 2018.
Knowing the applicable regulation and product code (as described above) is necessary for you to determine the classification of your medical device. Once you have this information, you will now be able to determine the “path” to get your product registered with FDA.

FDA defines three regulatory controls for each medical device class:

Class I medical device (low to moderate risk): General Controls
Class II medical device (moderate to high risk): General Controls and Special Controls
Class III medical device (high risk): General Controls and Premarket Approval (PMA)

Although these lists have been finalized by CDSCO following consultations with stakeholders, Operon Strategist by UL consultants note that the regulator has yet to add them to the SUGAM online device registration portal. Until their official including in the SUGAM portal, Indian medical device market registrants should use these lists only as references for finalizing risk classes of their products.