Medical device rules eased for outsourced sterilisation; EU added to stringent regulatory jurisdictions

The Union Health Ministry has proposed amendments to the Medical Devices Rules, 2017, aiming to streamline regulatory processes and improve ease of doing business for medical device manufacturers. The proposed changes focus on simplifying testing fee standardisation and accelerating market access for eligible medical devices.

A key amendment eliminates the need for a separate licence for outsourced sterilisation activities. Previously, manufacturers required a distinct permit even when the sterilisation facility already held a valid licence under the Medical Devices Rules, 2017. This duplication has been removed, reducing paperwork, administrative burdens, and compliance costs, especially for those without their own sterilisation facilities.

However, traceability remains mandatory, with manufacturers needing to include the sterilisation facility's licence number on the device label.

To facilitate a smooth transition, a six-month window is provided for companies to update their labels, packaging, and associated procedures. The government's objective is to strike a balance between regulatory oversight and ease of doing business, preserving traceability while simplifying the licensing framework.

Additionally, Rule 63 is amended to add the European Union (EU) to the list of stringent regulatory jurisdictions that allow waiving clinical investigation requirements for medical devices lacking a predicate device in India. Alongside the US, UK, Australia, Canada, and Japan, the EU's inclusion will enable medical devices approved in the EU, meeting specific eligibility conditions, to benefit from the waiver provisions in India.

This move is anticipated to shorten regulatory timelines for importers and manufacturers, enabling faster access to cutting-edge medical technologies for Indian patients.

The amendments stem from stakeholder consultations and align with the government's broader initiative to streamline the medical device regulatory framework while upholding quality, safety, and performance standards. Furthermore, these changes are anticipated to foster greater international regulatory convergence and enhance the competitiveness of India's medical device industry.