India Regulatory Framework Medical Device registration

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 devices 2017

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