Medical device rules eased for outsourced sterilisation; EU added to stringent regulatory jurisdictions
The amendments to the Medical Devices Rules, 2017, seek to simplify regulatory requirements, standardise testing fees and facilitate faster market access for eligible medical devices
The Union Health Ministry has proposed amendments to the Medical Devices Rules, 2017, to simplify regulatory requirements and expedite market access for eligible medical devices in India. The changes eliminate the need for a separate license for outsourced sterilisation, streamlining the process and reducing paperwork, administrative burden, and compliance costs for manufacturers without their own sterilisation facilities.
A six-month transition period has been granted to adapt labels, packaging, and related processes. Additionally, the European Union (EU) has been added to the list of stringent regulatory jurisdictions that can waive clinical investigation requirements for medical devices lacking predicate devices in India. This allows approved EU devices to benefit from the waiver provisions, potentially reducing regulatory timelines and increasing the availability of advanced medical technologies for Indian patients.
The amendments aim to balance regulatory oversight with ease of doing business while maintaining quality, safety, and performance standards for medical devices.
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