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Medical Devices have always been an object of concern and regulation by the Indian Government. With advancing medical technology and the exponentially rising need of medical devices in the country, new reforms and rules have come into effect. Medical devices have been categorized into A, B, C and D classes and are governed by respective central and state regulatory authorities.
(1) A - Low risk
(2) B - Low moderate risk
(3) C - Moderate high risk
(4) D - High risk
(1) Determine if your product requires registration
(2) Appoint an authorized indian agent
(3) Submit the regulatory dossier under from 40
(3) Obtain registration certificate in form 41
(3) Obtain import license in form 10
(1) PMS report.
(2) Plant master file.
(3) Device master file.
(4) Declaration of conformity.
(5) TR6 challan
(1) What is Medical device registration?
(2) Are clinical studies required for registration?
(3) Does a medical device need registration in india?
(3) Do all medical devices require a prescription?
