India Medical Device and IVD Regulatory Update

Two publications of interest have been released for companies marketing medical devices or in vitro devices (IVDs) in India.

A GUIDANCE DOCUMENT for MEDICAL DEVICES

This guidance represents the Indian Government’s perspective on medical devices entering the market, describing aspects such as classification, testing, and fees.

Read the guidance here.

Guidance on Performance Evaluation of In-vitro Diagnostic Medical Devices

New guidance is available on the performance evaluation of IVDs, including identifying which devices need reports from authorised testing sites. 

Read the guidance here.

 

 

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Published on 27. September 2018 in News