Centre moves to simplify medical device regulations, Pg12

Key Highlights:

• The Union Health Ministry has proposed amendments to the Medical Devices Rules, 2017, to simplify regulations and promote ease of doing business.
• Manufacturers will no longer need a separate loan licence for outsourced sterilisation if the facility already holds a valid licence.
• The European Union (EU) has been added to the list of stringent regulatory jurisdictions for waiving clinical investigation requirements.
• These changes aim to reduce paperwork, administrative burden, and facilitate faster market access for eligible medical devices.

Detailed Insights:

• The amendment to Rule 44 removes the need for duplicate licensing for sterilisation activities, easing compliance for manufacturers.
• A traceability requirement mandates manufacturers to mention the sterilisation facility's licence number on the medical device label.
• The inclusion of EU in Rule 63 expands the scope for waiving clinical investigations for devices without predicate devices in India.
• This move is expected to reduce regulatory timelines for importers and manufacturers, accelerating the availability of new medical technologies.
• The Medical Devices Rules, 2017, form the comprehensive regulatory framework for medical devices in India.
• A six-month transition period has been provided for companies to adapt to the new labelling and packaging requirements.

Key Concepts Involved:

• Medical Devices Rules, 2017: The comprehensive legal framework governing the manufacture, import, sale, and distribution of medical devices in India.
• Loan Licence: A licence granted to a manufacturer to use the premises and facilities of another licensed manufacturer for specific operations.
• Clinical Investigation: A systematic study conducted on human subjects to assess the safety and performance of a medical device.
• Predicate Device: A legally marketed medical device to which a new device can be compared to establish substantial equivalence for regulatory approval.