Medical Devices Services Notified Body by CDSCO (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 ("CDSCO") 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 CDSCO, 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"

Duties and Procedures of Notified Body

Duties:

1. Notified body shall perform the audit of manufacturer who applied under sub-rule (1) of rule 13. The specific application shall be allotted to the notified body by the State Licensing Authority through the portal of the Central Government. The audit shall relevant to domestic manufacturing site of Class A or Class B medical devices.
2. The notified body shall have standard operating procedure for identification, review and resolution of all cases where conflict of interest is suspected or proven. Record of such review and decision shall be maintained.

Procedure for audit:

The notified body shall carry out the audit in the following manner,-

(i) Technical review of respective documents as prescribed in the Fourth Schedule;

(ii) On-site audit of the manufacturer’s quality management system to establish conformity by examination of objective evidence, and that of sub-contractor wherever applicable, the requirements of the Fifth Schedule;

(iii) Establish conformity by examination and provision of objective evidences to the essential principles laid down by the Central Government from time to time. ;

(iv) Establish design conformity by review of the design documents during assessment of medical device to ensure its quality, safety, and performance;

(v) Record post approval changes, if any;

(vi) Assess conformity to the product and process standards as per provisions of these rules;

(vii) Inform the manufacturer about the observed noncompliances during audit, if any, and provide a copy of the audit report to the manufacturer;

(viii) When any major non-compliance is observed during audit by the notified body which may affect quality of the device, it may provide reasonable time to rectify the non-compliance followed by compliance verification of the manufacturing site;

(ix) The Notified Body, after assessment and verification, shall submit detailed report giving its findings on each aspect of audit along with its recommendations after completion of audit to the State Licensing Authority and a copy of the same to the manufacturer