Medical Devices (Third Amendment) Rules, 2026: EU Countries Added to Rule 63

Introduction

India has taken another significant step towards streamlining its medical device regulatory framework through G.S.R. 744(E), dated 14 August 2026, introducing the Medical Devices (Third Amendment) Rules, 2026.

The amendment further updates the Medical Devices Rules, 2017 (MDR 2017) and, importantly for manufacturers and importers, expands the countries recognised under Rule 63 to include European Union (EU) countries.

The amendment follows consideration of stakeholder comments on the draft notification issued vide G.S.R. 269(E), dated 10 April 2026.

What Has Changed?

The Third Amendment introduces three important changes to the Medical Devices Rules, 2017.

1. European Union Countries Added Under Rule 63

The most significant change is the amendment to Rule 63(1), Proviso (iv).

The words “or European Union countries” have been inserted after the existing reference to Japan.

This expands the list of recognised regulatory jurisdictions under the relevant provision.

2. Quality Management System Requirements Strengthened

The amendment also modifies Rule 19H(2)(v) and Rule 19J(2)(v).

The words “and Quality Management System” have been added after “standards”.

This formally brings Quality Management System (QMS) considerations into the relevant requirements concerning medical device testing laboratories and related regulatory processes.

3. Clarification of Government Medical Device Testing Laboratories

The marginal heading of Rule 19 has been changed to:

This provides greater clarity regarding the scope and function of government medical device testing laboratories under the Medical Devices Rules, 2017.

Why Is EU Inclusion Important?

The inclusion of EU countries is an important development for the Indian medical device industry.

The European Union represents one of the world's major medical device regulatory markets. Recognition of EU regulatory approvals within the relevant provisions of MDR 2017 can potentially make the Indian regulatory pathway more efficient for eligible products.

For manufacturers with products already approved in the EU, the amendment may help reduce duplication in certain regulatory requirements and facilitate a more streamlined approach to Indian market entry.

Potential Benefits for Medical Device Manufacturers

• Greater recognition of international regulatory approvals
• Potential reduction in duplication of regulatory requirements for eligible devices
• More efficient regulatory assessment for qualifying products
• Improved opportunities for EU-based manufacturers entering the Indian market
• Greater alignment between India's medical device regulatory framework and internationally recognised regulatory systems
• Increased clarity regarding QMS expectations in relevant testing-laboratory provisions

Impact on Indian Importers and Regulatory Teams

Indian authorised agents, importers and regulatory professionals should review their existing product portfolios in light of the amendment.

Companies dealing with devices approved or certified in EU countries should evaluate:

1. Whether the product falls within the scope of Rule 63.
2. Whether the EU regulatory approval satisfies the applicable conditions.
3. Whether additional Indian regulatory requirements continue to apply.
4. Whether existing technical documentation needs to be updated.
5. Whether product classification and intended use in India are consistent with the applicable regulatory framework.
6. Whether additional clinical, performance, quality or post-market requirements remain applicable.

A Step Towards Regulatory Harmonisation

The amendment reflects India's continuing effort to make the medical device regulatory system more predictable while maintaining requirements relating to quality, safety and performance.

The inclusion of EU countries alongside jurisdictions already recognised under Rule 63 represents an important move towards broader international regulatory recognition.

At the same time, the explicit inclusion of Quality Management System requirements demonstrates that regulatory simplification is being accompanied by continued emphasis on quality and regulatory oversight.

What Should Manufacturers Do Now?

Medical device manufacturers planning to enter or expand their presence in India should undertake a regulatory impact assessment of their products.

• EU approvals and certificates currently available
• Product classification under Indian regulations
• Applicable Rule 63 provisions
• Clinical investigation requirements, where applicable
• QMS documentation
• Technical documentation and applicable requirements
• Indian labelling requirements
• Import licensing requirements
• Post-market surveillance and vigilance obligations

How ACPL Can Support Medical Device Regulatory Compliance

Accredited Consultants Private Limited (ACPL) provides regulatory consultancy support to medical device manufacturers, importers and international businesses entering the Indian market.

• Medical device regulatory applicability assessment
• Medical device classification support
• Rule 63 applicability assessment
• Regulatory gap assessment
• Technical documentation review
• CDSCO import licence support
• CDSCO application support
• Regulatory query response support
• QMS documentation review
• Indian labelling assessment
• Post-market compliance support

Conclusion

G.S.R. 744(E), dated 14 August 2026, marks an important development in India's medical device regulatory framework.

By adding European Union countries under the relevant provision of Rule 63 and strengthening references to Quality Management Systems, the Medical Devices (Third Amendment) Rules, 2026 seek to facilitate a more internationally aligned and quality-focused regulatory environment.

For EU manufacturers and Indian importers, the amendment presents an opportunity to reassess existing regulatory strategies and identify products that may benefit from the revised provisions.

Nevertheless, EU approval should not be viewed as a substitute for Indian regulatory compliance. Each product must be evaluated against the applicable provisions of the Medical Devices Rules, 2017 and requirements of the Central Drugs Standard Control Organisation (CDSCO).

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