Industry Attracts India Govt's Focus on Gaps in Medical Device Rules 2016 Draft

Industry associations and their stakeholders have reviewed the medical device rules draft and responded by saying the draft has overlooked key components. In their response, they address concerns for structure and stability.

The Indian medical technology industry is on the brink of growth and value creation and they need “a scientifically well-thought regulatory regime which embodies the essence of industry growth and patient safety in equal measure”.

Industry experts note that measures to lift current restrictions on the shelf life of medical devices are needed to appreciate the usability of devices and establish trust in manufacturers’ quality systems. — Cynthia Jessup