Now Reading: India eases medical device sterilisation rules, adds EU to waiver list
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India eases medical device sterilisation rules, adds EU to waiver list
The Union health ministry has amended the Medical Devices Rules, 2017, removing the requirement for a separate loan licence when manufacturers outsource sterilisation of their products. The change, effective immediately with a…
The Union health ministry has amended the Medical Devices Rules, 2017, removing the requirement for a separate loan licence when manufacturers outsource sterilisation of their products. The change, effective immediately with a six-month transition for updated labelling, is intended to reduce duplication, administrative burden and compliance costs, particularly for firms without in-house sterilisation facilities. The ministry said it finalised the amendment after stakeholder consultations.
In a separate move, the ministry added the European Union to the list of recognised stringent regulatory jurisdictions for waiver of clinical investigation requirements for medical devices without predicate devices. The list already included the US, UK, Australia, Canada and Japan. Devices approved in the EU will now benefit from the waiver, which the ministry said will facilitate faster patient access to advanced technologies in India.
Both amendments follow the India-EU Free Trade Agreement signed in January. India imports 80-85% of its medical device needs, with imports rising 17% year-on-year to Rs 89,000 crore in FY26.
Indian Opinion Analysis
Both health.economictimes.indiatimes.com and hindustantimes.com report the same amendments neutrally as a regulatory change. The Times of India group outlet frames it as a consequence of the India-EU FTA, mentioning Piyush Goyal's delegation and the import surge of 17% to Rs 89,000 crore, adding context about high import dependency. Hindustan Times omits these figures and instead stresses stakeholder consultations and a balance between oversight and ease of business. The missed context is that the waiver list expansion directly aids EU multinationals, which dominate imports. The real development to track is the import data in FY27, which will show if the changes reduce India's 80-85% import reliance.
Coverage: 2 sources, 2 neutral
Sources (2): health.economictimes.indiatimes.com (neutral report), hindustantimes.com (neutral report)
This story was synthesised by AI from the 2 sources linked above.
Updated: this story now draws on 2 sources.
