What is CDSCO?
CDSCO stands for Central Drugs Standard Control Organisation, which comes under the Ministry of Health and Family Welfare, which is headquartered in Delhi. The CDSCO is the Indian regulatory body responsible for the approval, registration and regulation of drugs, medical devices, and other health related products in India. The rules and procedures involved in obtaining CDSCO registration in India are also laid down by the CDSCO under the Drugs and Cosmetics Act, 1940, the Medical Device Rules, 2017 and the Cosmetics Rules, 2020.
MEDICAL DEVICE STATUS
Effective April 1, 2020, the status of a medical device expanded beyond the 23 previously notified medical devices, requiring that all medical devices be registered under The Drugs and Cosmetics Act of 1940. Beginning October 1, 2022 all Class A and B medical devices must have Import Licenses prior to importation. All remaining Class C and D devices not already Notified will need to have Import Licenses by October 1, 2023. Medical devices that do not currently require Import Licenses must still register their product(s) through an ePortal in a couple of days.
PRODUCT CLASSIFICATION
Medical devices are classified into 4 categories; A, B, C, and D based on risk level. The CDSCO fees for application processing depend on the device classification.
Class A products are further divided into 2 categories to ascertain if CDSCO license or CDSCO registration is applicable on the product:
So, the manufacturer whose products comes under classification of Class A (Sterile or measuring), Class B, Class C and Class D require license from CDSCO.
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