Medical Devices Services (Notified Bo

Notified Body by COSCO (Central Drugs Standard Control Organization)

As per G.S.R. 78(E) MDR 2017; BSCIC Certifications Pvt. Ltd. has been designated as Notified Body for Class A and Class B Medical Devices from Central Drugs Standard Control Organization (CDSCO), New Delhi, India.

"Notified" means notified in the official gazette by the central government.

"Notified Body" means a body corporate or other legal entity, registered under rule 13 as a body competent to carry out the audit of manufacturing site, assessment, and verification of specified category of medical devices for establishing conformity with standards.

The Central Drugs Standard Control Organization ("COSCO"), in a notice dated 4th May, 2018, has announced the notified bodies registered with it to carry out audit of a manufacturing site of Class A or Class B of medical devices. As per Rule 13 of the Medical Devices Rules, 2017 an accredited notified body is required to register with the Central Licensing Authority if it intends to carry out audit of a manufacturing site of Class A or Class B of medical devices.

An accredited Notified Body will be competent to carry out audit of manufacturing sites of Class A and Class B medical devices, to check whether they conform to the Quality Management System and other applicable standards as advised by the State Licensing Authority.

The Drugs Controller General of India under the Rules, states that only the Notified bodies can Audit companies that are into manufacturing of medical devices, thus no other individual/ institution/ organization/party apart from the notified bodies are allowed to audit the manufacturing sites of Medical Device manufacturers. “The new set of Medical Devices Rules 2017, separating medical device industry from the pharmaceutical sector, has taken effect from January 2018. The Medical Devices Rules will regulate all aspects and activities pertaining to medical devices such as manufacture, sale & distribution, imports & exports, labeling, conducting of clinical trials, registration of laboratories for carrying out tests and recall of devices."

Medical Devices have been classified into four categories based on their risk type - Class A, B, C and D. Class A and B are low risk devices whereas C and D classified as higher risk products. For approvals and licensing in devices falling under categories C & D, Central Government will be directly involved.

As a Notified Body by COSCO, India will undertake on-site audit of the Quality Management Systems of the Medical Device Manufacturers of Class A and Class B categories, and may, on a case to case basis, be called upon to help in the verification and assessment of Class C and Class D medical devices"