Pharma & Healthcare Update: Regulatory Wrap 2025: Medical Devices Industry in India

Regulatory Wrap 2025: Medical Devices Industry in India

The most significant regulatory developments in India’s medical-devices sector in 2025 include:

• Digital pathways introduced for risk classification and import of approved medical devices.
• Regulatory measures impacting pricing, labelling and export facilitation for medical devices introduced.
• Draft guidance issued for regulation of software-based devices and IVDs.

INTRODUCTION

In 2025, the Indian medical-devices sector continued its transition towards a more structured, risk-based and digitised regulatory framework under the Medical Devices Rules, 2017. Regulatory developments during the year focused on improving regulatory predictability, streamlining approval and import processes, and reducing legacy overlaps with allied regulatory regimes. Alongside enforcement-oriented measures such as pricing oversight and updated risk-classification lists, the Central Drugs Standard Control Organization also advanced capacity-building initiatives through guidance documents and innovation handbooks. Collectively, these measures underscore India’s intent to balance patient safety, market access and industry growth, while aligning domestic regulation with global best practices in medical-device governance.

AUTO-GENERATED NEUTRAL CODE INTRODUCED FOR MEDICAL-DEVICE EXPORTS

The Central Drugs Standard Control Organization (“CDSCO”) vide notice dated April 9, 2025notified that manufacturers of licensed medical devices may now obtain a system-auto-generated “Neutral Code” for exports under the Medical Devices Rules, 2017 (“MDR”).¹

The new mechanism allows manufacturers with valid manufacturing licenses to download the Neutral Code directly from their dashboard on the online medical-device portal, replacing the earlier manual issuance by the Central Licensing Authority (“CLA”).

This update aims to streamline export-related compliance, especially in cases where exporters or overseas buyers request anonymised labelling — the Neutral Code substitutes for the manufacturer’s name and address on the product label/packaging for export consignments.

NPPA ISSUES PRICE-CONTROL DIRECTIVE FOR NON-SCHEDULED FORMULATIONS AND MEDICAL DEVICES

The National Pharmaceutical Pricing Authority (“NPPA”) issued a circular dated July 7, 2025 to provide clarity on the manner of increase of price of multiple brands of the drug falling under the purview of the Drugs (Price Control) Order, 2013 (“DPCO”).

The NPPA clarified that to ensure uniform pricing across different brands of the same non-scheduled formulation or device, inter-brand MRP differences must not exceed 10% i.e. the price for multiple brands of the same drug should not vary by more than 10%. The Circular reiterates that Maximum Retail Price (MRP) of non-scheduled formulations and medical devices falling under DPCO, cannot be increases by more than 10% in the preceding 12-month period as stated under the DPCO.

NPPA has also stated that non-compliance with the circular and the requirement prescribed therein will lead to penal action under DPCO, 2013 and the Essential Commodities Act, 1955, including recovery of overcharged amounts with interest from the manufacturers.² 

DOP ISSUED CIRCULAR STREAMLINING MEDICAL DEVICE MARKETING COMPLIANCES

The Department of Pharmaceuticals (“DoP”) – Medical Device Division, through a circular dated September 1, 2025 (“UCMPMD Circular”),³ amended the Uniform Code for Marketing Practices in Medical Devices, 2024 (“UCMPMD”) and revised the disclosure requirements introduced therein. It has also introduced compliances for the industry associations under the UCMPMD.

The UCMPMD Circular provides specific guidance on the method for valuing free evaluation samples distributed to HCPs, removes the requirement of publication of complaint details on the UCMPMD portal of the DoP and provides much needed clarity on the manner of submission of the prescribed disclosure requirements under the UCMPMD. The UCMPMD Circular also adds a new obligation for industry associations to establish secure systems for storing and safeguarding data provided by their member companies.

Previously, medical device companies were required to submit detailed disclosures of their monthly marketing expenditure directly to the DoP. Basis these revisions, companies are now required to submit these disclosures to the association of which the company is a member. Companies are also required to disclose the methodology adopted for calculating the expenditure incurred for activities such as distribution of free evaluation samples, undertaking continuous medical education or continuing professional development programs along with disclosure on the locations where the events were organised and the number of times such events were organised at each location.

By delegating compliance functions to industry associations and replacing monthly reporting with an annual reporting framework, the regulatory approach is likely to lessen the operational and compliance demands on medical device companies. These reforms continue to ensure oversight and reflect the underlying purpose of the UCMPMD, while encouraging stronger and more streamlined compliance across the medical devices sector.

NEW “SUBSEQUENT IMPORTER” PATHWAY INTRODUCED FOR APPROVED MEDICAL DEVICES AND IVDS

The CDSCO vide a circular dated September 15, 2025, introduced a mechanism for adding a subsequent importer for import of approved medical devices in India.

The Circular mentions a new mechanism on its online portal allowing entities to register as a “Subsequent Importer” for medical devices or in-vitro diagnostics (“IVDs”)  that have already been approved by the CLA under MDR. Thereby, not requiring duplication of registration and approval process for medical devices in India.

Effective from 11 September 2025, applicants intending to import such pre-approved devices may submit import applications under the “Subsequent Importer” category via the CDSCO portal, following a dedicated checklist provided for this purpose.⁴ This change aims to simplify and expedite the regulatory import process — by decoupling import applications from brand-approval/initial approval workflows — thereby reducing processing timelines for imports of devices already on the approved device registry.

CDSCO RELEASES DRAFT GUIDANCE ON REGULATION OF MEDICAL DEVICE SOFTWARE

The CDSCO issued the draft Guidance Document on Medical Device Software under Medical Devices Rules, 2017 (“Draft Guidance Document”) on October 21, 2025, to seek comments from stakeholders  on the proposed regulatory framework for software-based medical devices.⁵

The Draft Guidance Document intends to provide clarity on the manner of regulation of medical device software. The Draft Guidance Document explicitly distinguishes between Software as a Medical Device (SaMD) — standalone software performing medical functions — and Software in a Medical Device (SiMD) — software embedded in or integral to hardware devices; it also extends to software used in in-vitro diagnostics.
It provides a risk-based classification (Classes A–D) for medical-device software, aligned with MDR’s general classification logic, determining licensing pathways depending on risk class and intended use.

The Draft Guidance Document outlines the regulatory requirements for: technical documentation, quality management systems (“QMS”), safety and performance standards (e.g., compliance with relevant ISO/IEC norms), clinical/performance evaluation (where applicable), and post-market vigilance for software products.

Importantly, while the draft provides a structured roadmap for compliance, CDSCO clarifies that it does introduce a new regulation per se but aims to interpret and operationalise existing MDR-2017 provisions more consistently for software-based devices — improving clarity and regulatory predictability for the industry.

LEGAL METROLOGY (PACKAGED COMMODITIES) AMENDMENT RULES, 2025 — ALIGNMENT WITH MDR, 2017

The Ministry of Consumer Affairs through a notification dated October 23, 2025, notified the Legal Metrology (Packaged Commodities) Amendment Rules, 2025, aligning labelling requirements for medical devices with the MDR.

Under the new regime, all declarations on packages of medical devices — including the content, format and size of mandated particulars — are required to comply exclusively with the Medical Devices Rules, 2017 (“MDR”), overriding the general requirements under the Legal Metrology (Packaged Commodities) Rules, 2011 (“LMPC Rules, 2011”). Consequently, MDR-compliant labelling supersedes LMPC-prescribed numeral and font-size specifications, and exemptions or relaxations available under Rule 33 of the LMPC Rules — which earlier applied to institutional or industrial packages, exports and other non-retail supplies (including relaxations from MRP declaration and Principal Display Panel requirements) — are no longer applicable to medical devices. Further, the requirement under the LMPC Rules to display mandatory declarations on the Principal Display Panel in the prescribed manner does not apply to medical devices, as labelling is now governed entirely by the MDR framework.⁶

Prior to the amendment, medical devices companies were required to  simultaneously comply with the labelling requirements under both the LMPC Rules, 2011 and the Medical Devices Rules, 2017, leading to overlapping and, in some cases, conflicting obligations. This amendment resolves long-standing overlaps between LMPC and MDR, removing conflicting labelling requirements that applied simultaneously to device manufacturers and importers. By shifting medical-device packaging entirely under the MDR framework, the change simplifies compliance, reduces regulatory ambiguity and ensures a single, uniform labelling standard for the sector.

The amendment came into effect on October 23, 2025, and the implementation remains to be seen.

DIGITAL PERSONAL DATA PROTECTION (DPDP) RULES, 2025 NOTIFIED

The Ministry of Electronics and Information Technology (“MeitY”) notified the Digital Personal Data Protection Rules, 2025⁷ (“DPDP Rules”) on November 13, 2025, thereby operationalising the Digital Personal Data Protection Act, 2023 (“DPDP Act”). The DPDP Rules introduce a phased compliance framework, becoming effective after an 18-month transition period ending on May 13, 2027, requiring companies to put in place compliance mechanisms over the transition period. The Data Protection Rules prescribe minimum security standards which, among others, include implementing data security measures including encryption, obfuscation, masking or use of virtual tokens; retention of logs and personal data for 1 year to detect unauthorized access; and inclusion of appropriate contractual provisions in the contract between the Data Fiduciary and the Data Processor to adopt reasonable security safeguards.
If the Data Protection Board determines that a person has breached any provision of the DPDP Act, it may impose monetary penalties after conducting an inquiry and the fines can go up to INR 2,500,000,000.

A detailed analysis of this update is provided in our hotline.

CDSCO LAUNCHES NEW ONLINE MODULE FOR RISK CLASSIFICATION OF MEDICAL DEVICES

CDSCO vide its circular dated December 4, 2025, rolled out the new Risk Classification Module on the CDSCO Online System for Medical Devices to streamline the regulatory approval process for medical devices other than in-vitro diagnostic devices. The module has been made fully functional for stakeholders with effect from November 27, 2025.⁸

The new module operationalises a digitally integrated mechanism for submitting and processing risk classification requests for medical devices under the Medical Device Rules, 2017.This development is especially relevant for devices that are not included in the CDSCO-published classification list, a category that has historically required applicants to rely on manual correspondence or interpretative submissions to the licensing authorities.

The circular is expected to improve regulatory clarity and reduce approval timelines by providing a streamlined, digital mechanism for obtaining risk classification of medical devices not covered under existing CDSCO classification lists. The circular is part of CDSCO’s broader initiative to simplify approval procedures and reduce administrative burden on the medical device industry by digitally consolidating classification pathways. State/UT licensing authorities, CDSCO zonal and sub-zonal offices, and port offices have been notified of the change to ensure uniform implementation across regulatory touchpoints.

CDSCO PUBLISHES MEDTECH MITRA’S IN-VITRO DIAGNOSTIC INNOVATORS HANDBOOK

In December 2025, CDSCO released MedTech Mitra’s In-Vitro Diagnostic Innovators Handbook, jointly developed with the Indian Council of Medical Research (ICMR), as a comprehensive resource for stakeholders involved in In-Vitro Diagnostic (IVD) device development.⁹

The handbook provides structured, step-by-step guidance on key aspects of IVD innovation — including regulatory pathways, documentation requirements, performance evaluation, risk assessment, QMS compliance and post-market surveillance — aimed at helping developers, manufacturers and regulators navigate India’s regulatory framework for IVDs.

The document draws on existing CDSCO and ICMR regulatory frameworks and features practical tools such as “To-Do Lists” to support preparation for performance validation, regulatory submissions and market entry, thereby facilitating a more streamlined and predictable regulatory process for IVD medical devices.

DRAFT AMENDMENTS PROPOSED TO THE MEDICAL DEVICES RULES, 2017

The Ministry of Health and Family Welfare vide a notification dated December 15, 2025, issued draft amendment rules¹⁰ to the Medical Devices Rules, 2017, proposing a series of changes aimed at rationalising and modernising the regulatory framework for medical devices.

Key proposals include formal recognition of a registration-based pathway for Class A (non-sterile, non-measuring) devices, introduction of perpetual validity for manufacturing and import licences and registration certificates (subject to payment of retention fees), and rationalisation of inspection, sampling and reporting requirements. The draft amendments also propose changes impacting in-vitro diagnostic devices, including clarification of the applicability of quality and inspection schedules, and introduce additional reporting obligations for registered testing laboratories. Collectively, the proposals seek to streamline compliance processes, improve regulatory clarity and reinforce a risk-based, lifecycle-oriented regulatory approach.

The proposed amendments are expected to reduce regulatory friction, provide greater certainty on licence and registration validity, and strengthen lifecycle oversight, particularly for low-risk medical devices and IVD manufacturers.

CONCLUSION

These developments reaffirmed the growing strategic importance of India’s medical-devices sector, supported by increasing domestic demand, expanding global market access and a progressively structured regulatory framework. The regulatory initiatives undertaken during 2025 signal the continued evolution of a risk-based, digitised and innovation-oriented regime under the MDR.

As stakeholders adapt to clearer compliance pathways and invest in technology-driven solutions, the sector is well-positioned for sustained growth, higher innovation and an enhanced focus on quality, safety and patient outcomes in the years ahead.

Naveli Sharma, Shlok Siddhant, Tanya Kukade and Dr. Milind Antani
You can direct your queries or comments to the authors.

¹Accessible at: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTI2NDc=

²Accessible at: https://nppa.gov.in/uploads/tender/df307ca74333039353fc3c275745127d.pdf

³Accessible at: https://pharma-dept.gov.in/sites/default/files/ucmpmd%20circular%20with%20amended%20code_1.pdf

⁴Accessible at: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTMzMzE=

⁵Accessible at: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/Draft%20guidance%20document%20on%20Medical%20Device%20Software%2021%2010%202025.pdf

⁶Accessible at: https://consumeraffairs.gov.in/public/upload/files/267107_1761404707.pdf

⁷Accessible at: https://www.meity.gov.in/documents/act-and-policies/digital-personal-data-protection-rules-2025-gDOxUjMtQWa?pageTitle=Digital-Personal-Data-Protection-Rules-2025

⁸Accessible at: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTM2Njc=

⁹Accessible at: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTM2Nzc=

¹⁰Accessible at: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTM2OTY=