Medical Devices Rules 2017 amended: EU added, testing fees standardised
Synopsis
India has amended the Medical Devices Rules, 2017, to remove the separate loan licence requirement for outsourced sterilisation, introduce uniform laboratory testing fees via a new Ninth Schedule, and add the EU to its list of recognised regulatory jurisdictions — meaning EU-approved devices can now access the Indian market faster. The reforms mark a meaningful step in aligning India's device regulation with global standards.
Key Takeaways
The Ministry of Health and Family Welfare proposed amendments to the Medical Devices Rules, 2017 on 24 August .
Under revised Rule 44 , manufacturers using outsourced sterilisation no longer need a separate loan licence under Rule 25 , reducing compliance burden.
A new Ninth Schedule prescribes uniform testing fees across Medical Device Testing Laboratories , ending fee ambiguity.
Amended Rule 63 adds the European Union to the list of recognised stringent regulatory jurisdictions, joining the USA, UK, Australia, Canada, and Japan .
EU-approved medical devices without predicate devices are now eligible for waiver of clinical investigation requirements in India, enabling faster market access.
The Ministry of Health and Family Welfare (MoHFW) on 24 August proposed amendments to the Medical Devices Rules, 2017, aimed at simplifying regulatory compliance, introducing uniform testing fees, and accelerating market access for eligible medical devices in India. The changes, announced via an official statement, target three specific areas of the existing regulatory framework.
Key Amendments at a Glance
The reforms address outsourced sterilisation licensing, standardised laboratory testing fees, and the expansion of recognised stringent regulatory jurisdictions to include the European Union (EU). Together, they are designed to reduce documentation burden, cut approval timelines, and improve cost predictability for both domestic manufacturers and importers.
Sterilisation Licensing Made Simpler
Under the revised Rule 44 of the Medical Devices Rules, 2017, manufacturers that use outsourced sterilisation facilities will no longer need to obtain a separate loan licence under Rule 25 — provided the sterilisation facility itself holds a valid licence under the same rules. Previously, any manufacturer without an in-house sterilisation unit was required to secure a distinct loan licence for sterilisation activities, adding a layer of compliance cost and time. The amendment is expected to reduce documentation requirements, shorten approval timelines, and lower associated costs while enabling manufacturers to access specialised sterilisation infrastructure more efficiently.
Uniform Testing Fees via Ninth Schedule
A Ninth Schedule has been inserted into the Medical Devices Rules, 2017, prescribing standardised fees for the testing of medical devices by Medical Device Testing Laboratories. The move establishes a transparent, uniform fee structure across laboratories, eliminating ambiguity and variations in testing charges that had previously created unpredictability for manufacturers and importers. According to the MoHFW statement, the standardised structure is expected to minimise disputes, ensure equitable treatment of all stakeholders, and strengthen overall efficiency in the regulatory framework.
EU Joins List of Recognised Regulatory Jurisdictions
In a significant step for import facilitation, Rule 63 has been amended to include the European Union among the recognised stringent regulatory jurisdictions for the waiver of clinical investigation requirements — specifically for medical devices without predicate devices. The EU joins the United States of America, United Kingdom, Australia, Canada, and Japan on this list. Devices already approved by the EU's regulatory framework will now be eligible for faster market entry in India, reducing the regulatory burden and timelines for importers and manufacturers of such devices.
Broader Context and What Comes Next
The amendments form part of the government's broader push to promote Ease of Doing Business (EoDB) in the medical device sector, which has seen growing policy attention as India seeks to reduce import dependency and attract investment in domestic device manufacturing. This is not the first round of reforms to the 2017 rules — successive amendments have progressively aligned India's framework with global regulatory best practices. Industry stakeholders are expected to review the proposed amendments before they are finalised, and the changes are likely to benefit both multinational device makers and domestic manufacturers seeking to scale sterilisation operations without additional licensing overhead.
Point of View
Covering hundreds of products that were previously subject to full clinical investigation requirements in India. The sterilisation licensing change is operationally significant for mid-sized domestic manufacturers who lack in-house sterilisation but have been deterred by the loan licence overhead. What the reforms do not yet address is end-to-end approval timelines at the Central Drugs Standard Control Organisation, which remain a persistent friction point for the sector. Regulatory simplification at the rules level is necessary but not sufficient — implementation bandwidth at the regulator will determine whether these changes translate into measurable speed gains on the ground.
NationPress
24 Aug 2026
Frequently Asked Questions
What are the key changes in the Medical Devices Rules 2017 amendment?
The amendment makes three changes: it removes the requirement for a separate loan licence for outsourced sterilisation under Rule 44, introduces uniform testing fees via a new Ninth Schedule, and adds the European Union to the list of recognised stringent regulatory jurisdictions under Rule 63. Together, these aim to reduce compliance burden and speed up market access for eligible devices.
Why has the EU been added to India's list of recognised regulatory jurisdictions?
The EU has been added under amended Rule 63 so that medical devices already approved by the EU's regulatory framework — and without predicate devices — can qualify for a waiver of clinical investigation requirements in India. This brings the EU in line with the USA, UK, Australia, Canada, and Japan, which were already on the list, and is expected to reduce timelines and costs for importers and manufacturers of such devices.
What was the problem with outsourced sterilisation licensing before this amendment?
Previously, manufacturers without in-house sterilisation facilities were required to obtain a separate loan licence under Rule 25 specifically for sterilisation activities. This added documentation, cost, and approval time. The amended Rule 44 removes this requirement, provided the outsourced sterilisation facility itself holds a valid licence under the Medical Devices Rules, 2017.
How will uniform testing fees benefit manufacturers and importers?
The new Ninth Schedule prescribes standardised fees across all Medical Device Testing Laboratories, eliminating the variation and ambiguity in testing charges that previously created cost unpredictability. This is expected to minimise disputes, ensure equitable treatment, and make financial planning more straightforward for both domestic manufacturers and importers.
Which ministry announced these amendments and when?
The amendments were announced by the Ministry of Health and Family Welfare (MoHFW) on 24 August through an official statement, as part of the government's broader Ease of Doing Business reforms in the medical device sector.
