CDSCO 2025 Update on Class A List Non-Sterile Non-Measuring (NSNM) Medical Device Registration

CDSCO 2025 Update on Class A List Non-Sterile Non-Measuring (NSNM) Medical Device Registration

The major update from CDSCO for 2025 concerning Class A Non-Sterile, Non-Measuring (NSNM) medical devices is the continued exemption from needing a full manufacturing or import license. It allows businesses to place these low-risk devices on the market through a simplified self-declaration and online registration process on the Sugam portal.

The medical device industry in India is changing fast. The Central Drugs Standard Control Organisation (CDSCO) works to make sure all products are safe. They classify medical devices into four risk categories: Class A, B, C, and D. Initially every medical device no matter how simple was going to need a full license. This would have caused huge delays for low-risk products. The industry asked for relief. CDSCO simplified the rules for these specific low-risk devices. This important change, started back in 2022, is now fully settled and applied in 2025. 

The NSNM Exemption: Simplified Regulatory Path

The biggest news for Class A NSNM devices is the exemption from the full licensing regime. The government has officially carved out a simpler path. For devices that are not sterile and do not have a measuring function (like a thermometer or a dosing pump) you do not need to apply for a lengthy MD-5 (Manufacturing) or MD-15 (Import) license. Instead you follow a self-declaration route. This is much quicker and far less costly than a full license application. 

Read More What is CDSCO Medical Device Import Certificate?

Who Must Register?

The mandatory registration requirement applies to two main groups of entities. You cannot sell the device without this registration number.

Indian Manufacturers

If you make an NSNM device in India you must register. You declare that your manufacturing site and your device comply with the quality standards. The device must fit the Class A NSNM definition exactly. Your registration confirms your commitment to safety. 

Foreign Importers

If you bring an NSNM device into India from another country, you must register. As the importer, you become the official representative of the foreign manufacturer in India. You take on the responsibility for ensuring the imported device meets India's rules. You submit the registration application through the SUGAM portal. 

Essential Documents for Self-Declaration

Even though you skip the full license, you must still provide key documents.

The list of essential documents includes:

1. Undertaking
2. Self-Certification of Compliance
3. Standards Compliance
4. Manufacturing Site Details
5. Importer/Manufacturer Details

Read More Importance of CDSCO Online Registration for Pharmaceutical Companies

The Registration Process

The actual process of getting your registration number is now fast and digital, an easy transition.

1. Portal Registration: You must first register your company on the CDSCO SUGAM portal. You create an account. You get login credentials. This step is necessary for every applicant
2. Application Initiation: You log in to the portal. You select the application for Class A NSNM Medical Device Registration. You fill in the device details carefully, like its generic name, its intended use and its model number
3. Document Upload: You upload all the required self-declaration and support documents. They must be legible. They must be in the correct format
4. Fee Payment: There is no prescribed government fee for the NSNM device registration. This is a big financial benefit for low-risk devices. You simply proceed with the submission
5. Registration Number Generation: Upon successful submission of the required information the registration number is generated immediately by the online system. This number is your official approval. You must print this registration number on the device label for sale in India

Continuous Compliance and Post-Market Duties.

Getting the registration number is not the end of the journey. You have continuous responsibilities you must follow. The CDSCO can check your records at any time

1. Record Maintenance: You must maintain detailed records. These records cover the manufacturing the import and the sale of every device. You need to keep these records organized and accessible
2. Labeling Requirements: You must ensure your product labeling is correct. It must follow the Medical Devices Rules 2017. The label must clearly display the registration number you received. It must include the necessary warnings and instructions for safe use
3. Quality System: You must maintain a basic Quality Management System (QMS) even if you are not audited for a full ISO 13485 certification. You need to ensure your product quality remains consistent
4. Adverse Event Reporting: If your device causes any harm or injury you must report this adverse event to the CDSCO immediately. This helps protect public health. Failure to report problems is a serious regulatory violation

Why This Update Matters

The NSNM exemption is a game-changer for the Indian medical device market.

• Faster Time-to-Market: The process is now measured in days, not months. This allows immediate market access
• Cost Reduction: Zero government fee and no audit expenses save small businesses thousands of rupees, money they can use to expand.
• "Make in India" Boost: The simplified rules encourage Indian manufacturers to start making simple medical products locally, which is a big goal.

Final Words

The CDSCO’s streamlined registration process for Class A NSNM medical devices is a golden opportunity. You can bring essential and low-risk devices to market quickly and affordably. But remember the simplicity of the process does not mean you can ignore the rules. Self-certification means you the business are fully accountable

Need expert help verifying your device classification and ensuring all your self-declaration documents comply with the latest CDSCO 2025 norms? Contact Agile Regulatory today. We will guide you through the NSNM registration process and ensure you get full peace of mind.