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Indian Medical devices regulation basics
Here below are reported some of the most relevant guidance for Medical Device Registration in Indian market:
Major Regulations
Regulation Year Cosmetics Regulation in India 2010 India Medical Devices Rules 2017 General Guidance Documents
Document Year Guidance – Device/IVD Classification under the Medical Device Rules of 2017 2019 Guidance – Grouping Guidelines for Medical Devices Applications 2018 Additional Information
Document Year Frequently Asked Questions
–grouping guidelines
–IVDs
–medical devices2017 Doubts?
Reach out to us and we will help you clarify your situation
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Doubts ?
Reach out to us and we will help you clarify your situation