India's Ministry of Health has proposed amendments to the Medical Devices Rules, 2017, removing the need for a separate licence for outsourced sterilisation and adding the European Union to the list of stringent regulatory jurisdictions. The changes aim to standardise testing fees, cut paperwork and speed up market entry for eligible devices.

  • Separate licence for outsourced sterilisation eliminated
  • EU added to recognised stringent regulatory jurisdictions
  • Testing fees standardised and market access accelerated

The Union Health Ministry has tabled amendments to the Medical Devices Rules, 2017, with the objective of simplifying regulatory requirements, standardising testing fees and facilitating faster market access for eligible medical devices. This initiative is designed to lower compliance costs for manufacturers while preserving safety and performance standards.

Amendment to Rule 44 stipulates that manufacturers outsourcing sterilisation to a facility that already holds a valid licence under the Rules will no longer need to obtain a separate loan licence for the sterilisation activity. Previously, a duplicate licence was required, adding to paperwork and administrative burden.

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A traceability clause remains intact. Companies must now display the licence number of the sterilisation facility on the device label. A six‑month transition period has been granted to allow manufacturers to update labels, packaging and related processes.

Amendment to Rule 63 expands the list of recognised stringent regulatory jurisdictions to include the European Union (EU). Earlier, the United States, United Kingdom, Australia, Canada and Japan were the only jurisdictions whose approvals could waive clinical investigation requirements in India. Devices approved in the EU that meet eligibility criteria will now enjoy the same waiver.

This inclusion is expected to shrink regulatory timelines for importers and manufacturers, enabling newer technologies to reach Indian patients more quickly. It also promotes greater international regulatory convergence and boosts the competitiveness of India’s medical device sector.

The changes follow extensive stakeholder consultations and form part of a broader government effort to streamline the medical device regulatory framework while maintaining rigorous quality, safety and performance benchmarks.

Why This Matters

BozokMedia analysis shows that simplifying licensing for outsourced sterilisation removes a major bottleneck for small and medium‑sized manufacturers, while EU inclusion aligns India with global best‑practice regulatory frameworks, potentially attracting higher‑value foreign investments.

"These reforms will markedly improve efficiency and global competitiveness of India’s medical device industry," said an industry expert.
Did You Know?: India’s medical device exports grew at an average annual rate of 35% between 2020 and 2025.

Frequently Asked Questions

Question 1: Will manufacturers still need to list the sterilisation facility’s licence number on the label?

Answer: Yes, traceability remains mandatory, so the licence number must be displayed.

Question 2: What conditions must EU‑approved devices meet to qualify for the clinical investigation waiver?

Answer: The device must be approved under EU regulations and satisfy India’s eligibility criteria for the waiver.