In India, medical devices were regulated as drugs under the Drug and Cosmetic Act 1940. This concept has changed now, with publication on the Indian Medical Device rule 2017, issued by the Ministry of Health and Family Welfare via Notification No. G.S.R, 78(E) issued on 31st January 2017.
The Indian Medical Devices Rules 2017 are harmonized with the international regulatory practices and provide comprehensive legislation for the regulation of Medical Devices. The Indian Medical Devices Rules 2017 consists of 12 Chapters, 8 Schedules, and 40 Medical Devices.
Maven Profcon Services LLP. provides end-to-end services by establishing and implementing a quality management system, classifying your devices, getting test license and manufacturing license, submitting the application on Sugam portal, providing audit support, and responding to the queries.
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