STARTUP LEGAL2 Sept 2026
Health Ministry Proposes Medical Devices Rules Changes to Cut Compliance Costs
The Health Ministry has proposed changes to the Medical Devices Rules, 2017. Manufacturers using outside sterilisation will no longer need a separate loan licence if the facility already holds one. Testing fees will be standardised. The EU will be recognised for waiving clinical investigation needs. This means faster market access and lower compliance costs for device makers.
Key Statutory Highlights
- The proposed amendment removes the need for a separate loan licence for outsourced sterilisation when the facility has a valid licence.
- Testing fees for medical devices will be standardised under the proposed changes.
- The European Union will be recognised as a stringent regulatory jurisdiction, allowing clinical investigation requirements to be waived in some cases.
Actionable Advice for Taxpayers / Founders:If you manufacture medical devices, review your current sterilisation arrangements and check whether you can benefit from the proposed licence waiver once the rules are finalised.
Statutory Disclaimer: TaxQue Shorts are AI-assisted editorial briefs for compliance awareness. This brief has not passed every source check; confirm the original notification before acting. This does not constitute formal legal or CA counsel.
TaxQue News Desk
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