Regulatory Services Our clientele consists of numerous local and international manufacturers, distributors, importers, etc. We assist them by liaisoning on their behalf with all sections of the state and central Drugs Department for submission of applications, obtaining various permissions & approvals, obtaining clinical trial permissions, etc.

(b) An active diagnostic medical device referred to in sub-clause (1) of clause (a) shall be assigned to Class A, if it is intended to be used solely to illuminate a patient's body with light in the visible or near infrared spectrum. (c) An active diagnostic medical device referred to in clause (a) shall be assigned to Class C, if it is intended specifically for, — (1) the monitoring of vital phys ...

The manufacturer shall establish and maintain a record for each batch of medical device or in vitro diagnostic medical devices that provides traceability and identifies the amount manufactured and amount approved for distribution. The batch record shall be verified and approved. 7.5.1.2 Control of production and service provision—Specific requirements 7.5.1.2.1 Cleanliness of product and contamin ...