FIFTH SCHEDULE [Refer rules 20(3), 20(5), 20(8), 22(i)] QUALITY MANAGEMENT SYSTEM FOR MEDICAL DEVICES AND IN VITRO DIAGNOSTIC MEDICAL DEVICES 1. General Requirements: 1.1 This Schedule specifies requirements for a quality management system that shall be used by the manufacturer for the design and development, manufacture, packaging, labelling, testing, installation and servicing of medical device ...

3. As per the rules, for manufacture or import of new drugs, the manufacturers/ importer are required to obtain manufacturing/ import permission from CDSCO under the New Drugs and Clinical Trials Rules, 2019 before Licencing the product under the Drugs Rules, 1945. 4. Robust system for evaluation of applications of clinical trial and new drug which contains data of Chemistry, Manufacture, Control ...

(e) An active diagnostic medical device shall be assigned to Class C, if it is intended for the control or monitoring, or to be used to directly influence the performance, of any active diagnostic medical device referred to in clause (d). (f) Subject to clause (g), an active medical device shall be assigned to Class B, if it is intended for the administration, or removal of, any medicinal product ...

PRESENTATION AND SUBMISSION OF APPLICATION 1. In order to make regulatory review process as efficient for CDSCO as possible, the submission of applications for approval of clinical trials and new drugs to CDSCO ensuring conciseness, correctness, consistency and clarity. 2. A clear well-presented submission facilitates the evaluation process in a timely manner, whereas, a difficult-to-evaluation su ...