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India Consults On Aligning Medtech QMS Requirements With ISO 13485

This article was originally published in SRA

Executive Summary

The Indian government is inviting stakeholder feedback on proposed quality management system requirements for various types of medical devices and in vitro diagnostics that are formally regulated as drugs under the country's medicines framework1. The draft requirements are based on the international QMS standard ISO 13485:2013 which, when implemented, will bring the regulation of these products in line with the current international practice.

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