CDSCO 2025 Updates — New Devices Added to Mandatory Registration List: What Manufacturers and Importers Must Know

India’s medical device regulatory landscape changed significantly through 2024 and 2025 — and the pace of change is not slowing down. For manufacturers and importers operating in the Indian market, one question has become increasingly urgent: is your device now on the mandatory registration list?

The answer may have changed in the last twelve months — even if your device has been selling in India for years.

This article covers the key CDSCO regulatory updates from 2025, what they mean for devices that were previously unregulated or voluntarily registered, the new Risk Classification Module launched in November 2025, the October 2025 SLA directive, and what action manufacturers and importers need to take right now.

Background: How India’s Medical Device Registration System Works

To understand the 2025 updates, it helps to understand the structure they are built on.

Under the Medical Devices Rules (MDR), 2017, all medical devices in India are classified into four risk-based categories:

The MDR 2017 system distinguishes between two categories of devices:

• Notified devices — formally listed in CDSCO’s classification database under MDR 2017. Mandatory registration required before manufacturing or import for sale.
• Non-notified devices — devices not yet formally listed in the CDSCO classification database. These have traditionally been unregulated — but that is changing rapidly through CDSCO’s systematic notification programme.

The critical point: India is in an ongoing, multi-year process of bringing all medical devices under mandatory registration — starting with higher-risk classes and progressively extending to lower-risk categories. Each notification that moves a device category from “non-notified” to “notified” creates an immediate compliance obligation for all manufacturers and importers of that device.

The Non-Notified Class C and D Milestone: October 1, 2023 (Still Affecting Businesses in 2025)

The most significant mandatory registration expansion in recent years took effect on October 1, 2023 — and its compliance implications are still being worked through by many businesses in 2025.

Key milestone dates that manufacturers and importers must understand:

Critical for Class C and D manufacturers and importers: If you manufacture or import any Class C or D medical device in India — regardless of whether it was previously “non-notified” — you must now hold a valid CDSCO licence. Selling or importing without this licence since October 1, 2023 is a regulatory violation under MDR 2017 and the Drugs and Cosmetics Act, 1940.

Class A NSNM Exemption: 2025 Update

While Class C and D regulation tightened significantly, CDSCO also provided relief for the lowest-risk Class A category. Class A Non-Sterile, Non-Measuring (NSNM) devices are now exempt from mandatory licensing requirements.

As per Gazette Notification G.S.R. 777(E) dated October 14, 2022, Class A non-sterile and non-measuring devices come under the self-notified category — meaning the Indian Authorized Agent can obtain an automatic registration number on the SUGAM portal and use this number to import these devices without a full CDSCO licensing review process.

This exemption covers devices such as:

• Non-sterile surgical instruments (scissors, clamps, non-measuring forceps)
• Basic examination tools not involving measurement
• Certain non-sterile dressings and bandages

Important caveat: “Self-notified” does not mean unregulated. Class A NSNM devices still require a registration number — just via the streamlined self-notification pathway. Post-market surveillance obligations still apply.

Key 2025 CDSCO Regulatory Updates

Update 1: New Risk Classification Module — November 27, 2025 (Major)

One of the most significant CDSCO structural changes of 2025: CDSCO introduced a new Risk Classification Module on its online portal to simplify the approval process for medical devices other than in-vitro diagnostics (IVD). The module became functional on November 27, 2025, on the CDSCO Online System for Medical Devices at cdscomdonline.gov.in.

This feature enables applicants to submit risk-classification requests for devices that are not included in the currently published CDSCO risk-classification list.

What this means for manufacturers and importers:

• If your device is not currently listed in CDSCO’s published classification database, you can now formally apply for risk classification through this dedicated online module
• This is a significant improvement over the previous process where unclassified devices had no clear digital pathway to obtain classification
• Once classification is assigned by the Central Licensing Authority (CLA), you can proceed with the appropriate licence application (import or manufacturing)
• This module covers medical devices other than IVDs — a separate IVD pathway exists

Who needs to use this module immediately: Any manufacturer or importer whose device is not listed in CDSCO’s published classification list but is being sold or imported in India. Without official classification, you cannot apply for a licence — and without a licence, you cannot legally operate after October 1, 2023 for Class C/D devices.

Update 2: CDSCO Draft Risk Classification Updates — January 2025

On January 6, 2025, CDSCO released draft guidance updating the risk classification of many medical devices, with stakeholders invited to review and provide feedback by February 5, 2025.

This draft guidance was significant in scope — once finalized, this guidance document was intended to significantly amend previous guidance on medical device classification in India, intended to eliminate uncertainty for approximately 1,000 devices in applying the classification guidelines.

Final classification lists were subsequently issued for Interventional Radiology and Radiotherapy medical devices — two high-significance categories for Indian hospitals and importers. CDSCO issued the final classification lists for Interventional Radiology and Radiotherapy medical devices following the draft risk classification lists released in January 2025.

Implications: Any manufacturer or importer of Interventional Radiology or Radiotherapy devices must verify whether their specific devices are now formally classified — and ensure they hold the appropriate CDSCO licence based on the assigned class.

Update 3: October 2025 Directive to SLAs — Licensing Without Classification Prohibited

In October 2025, CDSCO issued a significant directive to all State and Union Territory Drug Controllers. CDSCO issued a directive aimed at streamlining the grant of manufacturing licenses for Class A and Class B medical devices, as well as in-vitro diagnostic (IVD) devices under MDR 2017. The circular reaffirmed the mandatory role of the Central Licensing Authority in the classification of devices prior to licensing by State Licensing Authorities.

CDSCO observed that certain manufacturers had obtained licenses from SLAs for devices that fell under unclassified categories but were incorrectly treated as low-risk, bypassing intended regulatory pathways and posing potential safety and compliance issues.

SLAs were directed to:

• Cease issuing licenses for unlisted or investigational devices without CLA classification
• Review all previously issued licenses to identify those granted in error
• Take corrective actions to ensure compliance with MDR 2017

What this means for manufacturers: If you hold a State-issued manufacturing licence for a device that was not formally classified by CDSCO’s CLA, your licence may be subject to review. This is particularly relevant for Class A and B device manufacturers who obtained licences in states that may not have followed the formal CLA classification process.

The directive creates a clear mandate: verify whether your device is listed in the CDSCO classification database. For unlisted or novel devices, approach the CLA for classification before initiating licence applications. Ensure all regulatory steps, including classification and approval pathways under MDR 2017, are strictly followed to avoid retrospective penalties or licence revocations.

Update 4: IVD-Specific Updates — In-Country Performance Evaluation

For In-Vitro Diagnostic (IVD) manufacturers and importers, a critical 2025 update: for new in-vitro diagnostic devices (Class B–D), clinical evaluation in India is mandatory, regardless of whether the device has received approval in another country.

This in-country performance evaluation requirement applies even if your IVD holds US FDA clearance, CE marking, or other international approvals. India requires India-specific clinical data — a requirement that significantly affects the registration timeline and documentation burden for IVD manufacturers.

Additionally, CDSCO released a draft guidance document for Import of In-Vitro Diagnostic Medical Devices in January 2026, inviting stakeholder comments. This guidance covers application pathways, checklists, timelines, and a list of common non-compliances observed in IVD import applications — making it essential reading for any IVD importer preparing an application.

Update 5: CDSCO FAQ Addenda — Clarifications on Registration Requirements

Through 2024 and 2025, CDSCO released multiple addenda to its FAQs on the Medical Device Rules, 2017. These addenda provided further clarification on various regulatory aspects, including the requirement of import licences for raw materials and components, procedures for post-approval changes, documentation for authorised agents, and import permissions through notified ports.

Key clarifications from the FAQ addenda relevant to mandatory registration:

• Import licence for raw materials and components: Clarification on when components and sub-assemblies require their own import licences versus being covered under the finished device licence
• Post-approval changes: Specific guidance on when changes to an approved device require a fresh application vs. a post-approval change (PAC) notification — critical for manufacturers who modify devices after initial registration
• Sterilization outsourcing: As per DTAB’s 92nd meeting (April 24, 2025), manufacturers no longer need a separate loan licence for outsourcing sterilization — provided the sterilization facility already holds a valid MD-3 or MD-9 licence
• Notified ports: Clarification on the specific ports of entry through which registered medical devices may be imported

Update 6: Auto-Generated Compliance Certificates — SUGAM Portal Enhancement

CDSCO introduced auto-generated compliance certificates — market standing and non-conviction certificates can now be produced electronically for licensed entities.

Additionally, a neutral export code system was launched — manufacturers exporting devices can now use a system-generated code. These portal improvements reduce administrative burden and improve transparency for licensed manufacturers and importers.

Update 7: Legal Metrology Amendment — October 2025

An amendment specifically applicable to medical devices, effective October 23, 2025, allows the application of the provisions of the Medical Devices Rules, 2017 instead of the Legal Metrology Rules for specified clauses. As a consequence, manufacturers are provided greater flexibility: manufacturers can place Legal Metrology declarations (customer care details, country of origin, MRP, etc.) anywhere on the package, and the size of letters and numerals on medical device labels should be clearly visible as per MDR 2017 rather than specific criteria under Legal Metrology.

This amendment reduces conflict between MDR 2017 and Legal Metrology labelling requirements — a practical issue that had caused compliance confusion for many device manufacturers and importers.

What This Means: Action Checklist for Manufacturers and Importers

Based on the 2025 updates, here is what manufacturers and importers must do immediately:

1

Check CDSCO’s Published Classification List

Verify whether every device you manufacture or import is listed in CDSCO’s current classification database on the SUGAM portal. The classification list is periodically updated — check it now, not when you last checked. If your device is listed, identify its class and confirm you hold the correct licence.

2

If Your Device Is Not Listed — Apply for Risk Classification Immediately

Use the new Risk Classification Module on cdscomdonline.gov.in (launched November 27, 2025) to submit a classification request. This is now the formal pathway for devices not in CDSCO’s published list. Do not continue importing or manufacturing without classification — particularly for Class C/D devices where mandatory registration has been in effect since October 1, 2023.

3

Review Your State-Issued Manufacturing Licences

Following CDSCO’s October 2025 directive, SLAs have been instructed to review all previously issued licences for unlisted or investigational devices. If you hold a State-issued licence for a device that was not formally classified by CDSCO’s CLA, proactively verify the classification status and regularize if needed — before CDSCO or SLA enforcement action.

4

For IVD Manufacturers — Review In-Country Performance Evaluation Requirements

If you are importing or manufacturing Class B–D IVDs, ensure your registration dossier includes India-specific clinical evaluation data. International approvals (FDA, CE) are supportive but not substitutes for India-specific performance evaluation. Review CDSCO’s January 2026 draft guidance for IVD import applications for the latest procedural requirements.

5

Review Labels for October 2025 Legal Metrology Changes

The October 2025 Legal Metrology amendment gives manufacturers more flexibility on label layout — but the required information (MRP, country of origin, customer care details) must still be present and clearly visible per MDR 2017 standards. Review current labels to ensure compliance and leverage the new flexibility where needed.

6

Respond to Pending CDSCO Applications — New Rejection Policy

CDSCO announced a new policy to reduce application backlog: CDSCO will issue reminders at fixed intervals for pending queries. After three reminders, a fourth final notice will be sent informing about the rejection of the application and forfeiture of the fee paid. If you have pending CDSCO applications with outstanding queries — respond immediately. Application abandonment now results in fee forfeiture.

Classification Check: How to Verify Your Device’s Status

There are three ways to check whether your device is currently classified and what class it falls under:

Recommended approach: It is strongly recommended that the device be brought into line with requirements well before notification to make a smooth transition for the future period of enforcement. Voluntary registration — where still available — is significantly less burdensome than mandatory registration under enforcement pressure.

What Devices Should Watch for Forthcoming Notifications

While CDSCO has not officially pre-announced specific upcoming notifications, the following device categories have been the subject of regulatory discussion and are likely candidates for formal classification or reclassification in the near future:

• Software as a Medical Device (SaMD) — AI-driven diagnostic tools, clinical decision support software, and health monitoring apps are under active regulatory consideration globally and in India
• Wearable health monitoring devices — smartwatch-integrated health monitors, continuous glucose monitoring patches
• Aesthetic and cosmetic devices — laser devices, radiofrequency devices, and light-based treatments used in cosmetic medicine
• Point-of-care IVDs — rapid diagnostic tests and home-use diagnostic kits
• Single-use surgical instruments — disposable surgical tools that were previously unregulated

Manufacturers in these categories should consider proactive voluntary registration or risk classification application before mandatory notification brings additional scrutiny and enforcement timelines.

The Bigger Picture: India’s Regulatory Journey

India’s medical device market is the fourth largest in Asia — and the Government of India is systematically building a regulatory infrastructure to match. The MDR 2017 system, the SUGAM portal, the new cdscomdonline.gov.in system for medical devices, and the progressive notification of all device categories represent India’s deliberate move toward a globally aligned, risk-based medical device regulatory framework.

For manufacturers and importers, the message is clear: the window for operating outside India’s regulatory framework is closing. Devices that were unregulated in 2018 required voluntary registration by 2022. Voluntary registration became mandatory registration by 2023. New classification tools in 2025 remove the last ambiguities about how to get unclassified devices into the system.

Compliance now is significantly less expensive — in time, money, and business risk — than compliance under enforcement pressure later.

Need Help Determining if Your Device Now Requires CDSCO Registration?

We assist manufacturers and importers with:

• Device classification verification — CDSCO database search and MDR 2017 First Schedule analysis
• Risk Classification Module applications (cdscomdonline.gov.in) — for devices not in the published list
• Import licence applications (MD-14 → MD-15) for newly notified devices
• Manufacturing licence applications (MD-7 → MD-9 for Class C/D)
• State licence review and regularization for improperly licensed devices
• IVD registration including in-country performance evaluation planning
• Post-approval change management and retention compliance

Not sure if your device now needs CDSCO registration? Get a free classification assessment today →