Centre Proposes Medical Devices Rules Amendments to Streamline Licensing and Strengthen Regulatory Compliance

July 03, 2026

In April 2026, CDSCO issued a draft notification under G.S.R. 270(E) proposing specific amendments to the Medical Devices Rules, 2017. It follows a sustained period of regulatory evolution across medical device licensing in India that has included a major CDSCO directive in October 2025, three substantive FAQ addenda in 2025, and draft guidance on software-as-medical-device (SaMD).

Together, these developments represent one of the most significant regulatory reform cycles the Indian medical device sector has experienced since the Medical Devices Rules, 2017 came into force. For manufacturers, importers, and investors in India's medical device sector, understanding these changes is now a commercial priority.

What the 2026 Amendment Proposes

The draft Medical Devices (Amendment) Rules, 2026 make targeted but meaningful changes to the existing MDR 2017 framework. The most commercially significant is the introduction of a formal definition for Certificate of Registration under the CDSCO medical device registration framework. This provides regulatory clarity around a concept that had long existed in practice but lacked an explicit legal definition, reducing interpretation risk for manufacturers and licensing authorities alike.

The amendment also strengthens labelling requirements. Specifically, the sterilization site license number must now be mentioned on the label of sterile medical devices. This change improves product traceability and creates a direct link between the label and the licensed sterilization facility.

For manufacturers outsourcing sterilization or running multi-site operations, this creates a documentation and label management requirement that must be integrated into the quality system from production planning onwards.

The draft also refines language within the licensing process to remove ambiguity and proposes structured testing fees, bringing greater clarity to the CDSCO medical device approval process in India. Stakeholders have been invited to submit feedback within the prescribed consultation period, standard practice under medical device regulatory reforms in India. The amendment will come into force from the date of final publication in the Official Gazette.

The October 2025 Directive: Centralised Classification First

The proposed amendment follows one of the most consequential CDSCO directives issued in recent years, the October 23, 2025 circular that reaffirmed the mandatory role of the Central Licensing Authority in classifying medical devices before any State Licensing Authority can issue manufacturing licences.

The background matters. CDSCO observed that some manufacturers had obtained licenses from SLAs for devices that were either unclassified at the Central level, or that fell under categories requiring CLA oversight but had been incorrectly treated as low-risk products. This created safety and compliance risks.

The October 2025 directive addressed this directly: SLAs must cease issuing licenses for unlisted or investigational devices without prior CLA classification. Previously granted licenses that may have bypassed this pathway must be reviewed. Manufacturers were directed to verify their device classification in the CDSCO database and approach the CLA for formal classification before applying for a manufacturing licence if their device is not listed.

For medical device manufacturing in India, this directive has an immediate practical implication. Any manufacturer planning to apply for a manufacturing licence, whether for a new product or an existing product in a previously unlicensed facility, must begin with CLA classification verification, not with the SLA application. Getting this sequence wrong does not just delay the licence. It creates retroactive compliance risk for licences that were obtained in the wrong order.

The 2025 FAQ Addenda: Filling the Compliance Gaps

CDSCO also released three significant FAQ addenda in 2025 that have materially improved CDSCO regulations transparency for manufacturers and importers. The first, in April 2025, addressed regulatory procedures, biocompatibility requirements, site-specific applications, and post-market surveillance obligations. Post-market surveillance under MDR 2017 is no longer an afterthought, it is an active compliance responsibility.

The second addendum, in July 2025, clarified labelling requirements under the MDR 2017 framework, addressed re-import approval procedures and post-approval change processes, and provided additional guidance on general licensing matters. It confirmed that when a company changes its authorized Indian representative, a fresh import license is required. There is currently no transfer mechanism. The third addendum, in November 2025, focused on import license requirements for raw materials and device components, and documentation requirements for authorized agents.

Taken together, these three addenda have substantially reduced the ambiguity that manufacturers and importers faced when navigating the medical device licensing process. Post-approval changes must now be submitted through the SUGAM portal, with minor modifications typically reviewed in 2 to 4 weeks.

Software as a Medical Device: New Guidance for a Growing Category

The regulatory evolution also extends to a category that did not exist when the original MDR 2017 framework was written. In October 2025, CDSCO issued a comprehensive Draft Guidance Document on Medical Device Software, the most detailed regulatory clarification on SaMD India has produced.

The guidance does not create new regulatory requirements. Instead, it clarifies how existing MDR 2017 provisions apply to standalone software used for medical purposes, including AI-assisted diagnostics, clinical decision support tools, and disease monitoring applications.

The guidance addresses several areas of regulatory uncertainty, including when software qualifies as a medical device, lifecycle classification, risk management, and post-deployment obligations for AI and machine learning systems.

For companies developing digital health tools or AI-driven diagnostics for the Indian market, this guidance reduces the interpretive risk that previously made regulatory strategy difficult to plan. The final version is expected following stakeholder consultation that ran through late 2025 and early 2026.

What This Regulatory Cycle Means for Manufacturers

India's medical device regulatory framework is evolving systematically. Mandatory registration perimeters are expanding, since October 2023, all Class C and Class D devices must hold valid CDSCO licences, including previously non-notified devices. Class A Non-Sterile, Non-Measuring devices were recently exempted from mandatory licensing, providing targeted relief for the lowest-risk segment.

The digital SUGAM portal has compressed submission cycle times and raised documentation standards simultaneously. Compliance is no longer a one-time event, it requires active management of licence renewal cycles, surveillance obligations, post-market reporting, and labelling accuracy.

For manufacturers planning new facilities or capacity expansions, these reforms make upfront compliance planning more important, not less. Certification timelines of 3 to 6 months for well-prepared facilities versus 9 to 18 months for those with documentation gaps represent a direct commercial difference, one that affects production launch dates, PLI milestone eligibility, and supply commitments to hospital and institutional buyers.

Understanding the medical device compliance in India roadmap early and designing facilities and quality systems to meet it from the start is the most effective risk management approach available.

India's medical device regulatory framework is getting more structured, more digitised, and harder to navigate without preparation. For manufacturers, that is not a burden — it is a competitive advantage waiting to be claimed by those who get there first.

IMARC Engineering's Perspective

The Medical Devices (Amendment) Rules, 2026 build on a regulatory framework that has been tightening consistently since 2017, and IMARC Engineering sees its practical implications in every medical device manufacturing project we support. The sterilization site license number requirement on labels is a manufacturing documentation challenge as much as a regulatory one.

The Certificate of Registration definition change affects how quality teams structure their regulatory files. The broader compliance trajectory, more structured, more digitised, more auditable, demands that medical device manufacturing facilities in India are designed from the outset with the documentation systems, quality infrastructure, and regulatory workflow capabilities that CDSCO and state licensing authorities expect on inspection.

At IMARC Engineering, we build this into the DPR and detailed engineering phase of every medical device facility project: cleanroom design aligned to ISO 13485 requirements, quality management system infrastructure, equipment qualification protocols, and documentation workflows that support ongoing regulatory compliance for medical devices, not just initial licensing.

As the regulatory bar rises, facilities that were designed to meet it from Day 1 will carry a permanent advantage over those that are retrofitting compliance after construction.