India eases medical device rules to boost business

It simplified the regulatory framework governing outsourced sterilisation of medical devices.

India has introduced regulatory reforms in the medical device sector to promote Ease of Doing Business.

The government amended Medical Devices Rules, 2017 to simplify the regulatory framework governing outsourced sterilisation of medical devices and expand the list of recognised stringent regulatory jurisdictions.

Manufacturers outsourcing product sterilisation to another facility holding a valid licence will no longer be required to obtain a separate loan licence.

The amendment also eliminates the requirement for a separate loan licensing process in such cases, reducing duplication, administrative burden, and compliance costs.

To allow manufacturers adequate time to make necessary changes, a six-month implementation transition period will be in effect.

Additionally, Rule 63 of the Medical Devices Rules, 2017 has been amended to include the European Union (EU) amongst the recognised stringent regulatory jurisdictions.

With this, eligible medical devices already approved in the EU will benefit from the waiver provisions for faster patient access to advanced medical technologies in India.