AMCHAM Medical Device Committee’s input on Trade Margin Rationalization of Non-Scheduled Medical Devices

Medical Device Committee submitted the observations and shared inputs /suggestions to improve the Research development of Medical Devices”. Submitted recommendations pertaining Standards of Medical Devices – AMCHAM industry members believes that this is a very pragmatic approach and hope that emphasis will be laid on horizontal QMS standards and onus will be on the innovative medical Device Companies to establish compliance with functional standards based on Essential Principles of Safety and performance of medical devices, rather than dogmatic old product standards which stifles innovation. Another submission was about Transitory Provisions & Repeal and Savings. AMCHAM welcomes the move on continuation of Nineth Schedule Rules, namely: The Medical Devices Rules, 2017 & The New Drugs and Clinical Trials Rules, 2019. These Rules are created after detailed consultation and conforms to the best practices. Regarding non-compliance with quality standards –submitted recommendation to draft a Standard Operating Procedure on Causality Analysis for adverse events before proceeding with such clauses. The proposed act should define a proper mechanism to do the causality analysis of any adverse event on patient, before establishing whether the drugs, /devices are indeed spurious or adulterated or misbranded. Give our full support to work closely with regulators – to ensure patient safety and compensation but also to eliminate the harsher clauses which may deter launch of differentiated technologies.”