CDSCO Introduces Online Risk Classification Portal for Medical Device Importers and Manufacturers

Medical device risk classification remains one of the most critical and uncertain steps in India’s medical device licensing process. CDSCO’s newly launched online risk classification facility offers manufacturers and importers an official, pre-filing mechanism to confirm a device’s risk class before committing to a full regulatory application.

India’s medical device regulator, the Central Drugs Standard Control Organization (CDSCO), has introduced a new online facility that allows manufacturers and importers to obtain official confirmation of a medical device’s risk classification before applying for a license.

Medical device classification in India is based on risk, intended use, and invasiveness under the Medical Device Rules, 2017. Unlike many global systems, manufacturers and importers in India cannot self-declare a device’s risk class, making early clarity on classification critical.

To address this challenge, CDSCO has now introduced a new online risk classification module on its online system for medical devices. The facility became operational on November 27, 2025.

Regulatory background: Why risk classification is critical in India

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Unlike many global jurisdictions, manufacturers and importers in India cannot self-declare the risk class of their devices. Risk classification directly influences:

• The type of license required
• Whether the licensing authority is CDSCO or the state drug authority
• Documentation and clinical data requirements
• Government fees and approval timelines

In practice, licensing for Class A and Class B devices is handled by state authorities, which has sometimes led to inconsistent classification outcomes for similar products across different states, creating uncertainty for businesses.

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What the new risk classification facility provides

To address these challenges, CDSCO has introduced a voluntary, pre-filing risk classification module that allows applicants to seek official confirmation of a device’s risk class before submitting a full license application.

Key features of the facility include the following:

• Available online via the CDSCO medical devices portal
• Applies to medical devices only, excluding in-vitro diagnostic (IVD) devices
• Intended for devices not already listed in CDSCO’s published classification lists
• No consultation fee is charged

The online facility does not change India’s classification rules; it provides a clearer and more predictable mechanism for applying them. Click here to check out the details: www.cdscomdonline.gov.in

How the facility fits into India’s classification process

Under India’s regulatory framework, a medical device is first mapped to a relevant product category (such as cardiovascular, orthopedic, imaging, or software). Then, the CDSCO assigns the final risk class (Class A, B, C, or D). The assigned risk class determines the licensing pathway and compliance requirements.

The new module allows companies to clarify the risk classification before committing resources to a full regulatory filing.

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Who should consider using this option?

The facility is particularly useful for:

• New or innovative medical devices
• Products with borderline or unclear risk profiles
• Devices that do not clearly align with existing CDSCO classification examples

Early confirmation helps reduce the risk of reclassification, delays, or regulatory back-and-forth later in the approval process.

Information required for the application

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To seek risk classification confirmation, applicants are required to submit basic supporting information, including:

1. Existing device labels
2. Instructions for use
3. Regulatory status or approvals in other major markets (such as the US, European Union, the UK, Japan, Canada, or Australia)

Timelines and practical considerations for medical device importers

There is no prescribed timeline for CDSCO to issue a response. As a result, companies are advised to pursue the classification consultation in parallel with the preparation of their main regulatory dossier, rather than waiting for the consultation to conclude.

Key takeaway for manufacturers and importers

The new CDSCO risk classification facility addresses one of the most persistent challenges in India’s medical device regulatory system: uncertainty at the classification stage. Used strategically, it enables companies to select the correct licensing pathway early, plan costs and approval timelines more accurately, reduce regulatory friction and rework and align India-specific approvals with global regulatory strategy

Overall, the initiative improves transparency, predictability, and regulatory confidence for medical device companies looking to enter or expand in the Indian market.

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