Govt eases medical device rules, speeds access to EU-approved products
Amendments to India's medical devices rules allow manufacturers to outsource sterilization without obtaining a separate loan licence if the third-party facility is already licensed.
The Indian government has made changes to medical device licensing rules to speed up access to EU-approved products and reduce compliance costs. The amendments to the Medical Devices Rules of 2017 eliminate the need for manufacturers outsourcing sterilization to obtain a separate "loan licence" if the sterilization facility already holds a valid licence.
After a six-month transition period, companies must simply print the sterilization facility's licence number on the product label. The government has also added the European Union to its list of recognized regulatory jurisdictions, allowing EU-approved medical devices to gain faster access to India without undergoing local clinical investigations.
This move is aimed at reducing paperwork, shortening market entry timelines, and cutting compliance costs for the medical device sector.
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