In India, medical devices are regulated by the Central Drugs Standard Control Organization (CDSCO), which ensures that these devices meet the required safety and performance standards before they reach the market. Non-sterile, non-measuring medical devices are essential components of the health care system, and regulations governing their import and manufacturing help protect patients and health care professionals. The CDSCO ensures that medical devices in India meet the highest standards of safety, quality and efficacy. For non-sterile, non-measurement medical devices, the regulatory framework governs various aspects of their manufacturing, import and distribution in India.

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What are Non-Sterile, Non-Measuring Medical Devices? 

Non sterile, non-measuring medical devices are devices used in healthcare that do not need to be sterilized before use and are not designed to measure parameters such as weight, pressure or temperature. These devices are typically used in medical settings for diagnostic, therapeutic or supportive purposes without direct contact with the patient's internal body systems that require sterility or measurement. These are registered under the CDSCO medical device registration. Examples include items such as bandages, examination gloves, splints, and non-invasive diagnostic equipment. 

Since they do not enter or measure sterile body areas, they are generally less complex in terms of manufacturing and use. These devices are essential in providing care, as they assist in routine medical procedures, wound care, and general patient support. Their simplicity and effectiveness make them indispensable to the healthcare environment, allowing for effective treatment and patient management without the need for extreme sterilization or precise measuring instruments.

Regulatory Framework of CDSCO for NSNM Medical Devices

The Central Drug Standard Control Organization (CDSCO) plays a key role in regulating medical devices in India. CDSCO has outlined specific regulations under the Medical Devices Rules, which were framed in 2017. These rules are part of India’s broader strategy to ensure that medical devices in the market meet the required standards for safety and effectiveness.

Non-sterile, non-measuring medical devices fall under Class A according to the CDSCO classification system. Class A medical devices are those that present a low risk to the patient and are generally easy to manufacture and use. These devices do not pose significant risks to the patient and, therefore, do not require the same regulatory scrutiny as higher-risk devices such as Class B, C, or D devices.

To sell or import these devices in India, manufacturers and importers are required to register the products with CDSCO. The registration process ensures that the device complies with the safety and performance standards set by the government. For non-sterile, non-measuring devices, the registration process is relatively straightforward but specific guidelines must still be followed.

Also Read: CDSCO Manufacturing License for Medical Devices

Who can Apply for Registration?

The CDSCO registration process for non-sterile, non-measuring medical devices is open to:

• Manufacturers based in India: Any manufacturer based in India who manufactures medical devices that fall under the Class A (non-sterile, measuring) category.
• Importers: Any importer based in India who wishes to import medical devices from abroad that fall under Class A (non-sterile, non-measurable) category.

These entities must apply for a registration number from CDSCO to legally market and sell the devices in India. Registration confirms that the device complies with Indian medical device regulations and meets the necessary safety and performance standards.

Important Documents for CDSCO Registration

A number of important documents must be provided during the registration process for non-sterile, non-measuring medical devices. These documents ensure that the device meets the necessary safety and performance standards. Some of the required documents include:

• Manufacturer/importer agreement: A statement that certifies that the device is a non-sterile, non-measuring medical device.
• Self-certification of conformity: A declaration that the product meets the essential principles of safety and performance.
• Responsibility for authenticity: A signed declaration from the manufacturer/importer confirming that the information provided is accurate and authentic.
• Free Sale Certificate (FSC): For importers, a Free Sale Certificate from the manufacturer's country is required to verify that the device has been legally sold in the exporting country.
• Overseas manufacturing site registration: Self-attested copy of the overseas manufacturing site, establishment, or plant registration.

How to Apply for CDSCO Registration?

The process of applying for CDSCO registration for NSNM medical devices involves several important steps. The steps are explained below:

1. Verify product classification: Ensure that the product qualifies as a Class A non-sterile and non-measuring medical device according to CDSCO regulations.
2. Register on SUGAM portal: Complete the online registration by filling the required details through CDSCO SUGAM Portal for medical device registration.
3. Submit regulatory documents: Submit the required regulatory documents as per Section 2A and Section 2B of the CDSCO Guidelines. Ensure that all documents are complete and accurate.
4. Document compliance: Ensure that the submitted documents fully meet the requirements of CDSCO. Verify that they are consistent with the standards required for approval and registration.

Also Read: How to Get CDSCO Registration Certificate in India

Validity of CDSCO Registration Certificate

Currently, CDSCO has not set a specific period for the registration number of non-sterile, measuring medical devices. The registration number can generally be used indefinitely, unless the regulatory framework is updated or stricter rules are implemented in the future. It is important for manufacturers and importers to be aware of any changes to the regulations that may affect the registration status of their products.

Timeline for CDSCO NSNM Registration

The registration process through the SUGAM portal is designed to be fast and efficient. Once the necessary details and documents are submitted, the manufacturer or importer can usually obtain a registration number immediately, as the process is handled through an online system. However, applicants must ensure that all information is provided accurately to avoid delays in the approval process.

Essential Tips for Successful CDSCO NSNM Registration for Importers and Manufacturers

To ensure a smooth registration process, applicants should consider the following tips:

• Review the essential principles (EP) checklist: Before applying, the applicant should carefully review the EP Checklist to ensure that the product complies with safety and performance standards.
• Ensure the accuracy of the documents: All documents submitted must be correct and complete. Any errors or missing information may lead to a delay or rejection of the application.
• Self-certification is very important: The manufacturer/importer must provide a self-certification that confirms that the device complies with the relevant safety and performance standards.
• FSC for importers: Importers must ensure that they provide a valid Free Sale Certificate (FSC) from the country of manufacture.
• Information verification: An undertaking must be submitted to verify the authenticity of the details provided in the application.

Conclusion

CDSCO plays a vital role in ensuring the safety, quality and effectiveness of non-sterile, non-measurable medical devices in India. The regulatory framework ensures that such devices meet the necessary safety standards while allowing for smooth manufacturing, import and distribution processes. The registration process for these devices, although relatively straightforward, requires adherence to specific guidelines and key documents including self-certifications, free sale certificates, and manufacturer agreements. By following these regulations, manufacturers and importers can ensure that their products meet the required standards for public safety and compliance with Indian laws. Staying updated on the latest regulatory changes is essential to maintaining the validity of CDSCO registration.