CDSCO Registration for Non Sterile Non Measuring (NSNM) Medical Device (Import and Manufacturer)
Non-Sterile Non-Measuring (NSNM) Medical Devices are generally low-risk medical devices. They are supplied in a non-sterile condition and do not measure or monitor any body function. These devices usually have a simple design and may have no contact or only limited contact with the human body. Examples include adhesive bandages, cotton swabs, tongue depressors, non-medicated disposable gloves, and elastic bandages.
In India, medical devices are regulated by the Central Drugs Standard Control Organization (CDSCO). CDSCO helps ensure that medical devices meet the required standards for safety, quality, and performance before they are manufactured, imported, or sold in India. Class A medical devices are generally considered the lowest-risk category and commonly include non-sterile and non-measuring devices.
For manufacturers and importers, CDSCO Registration for Non-Sterile Non-Measuring (NSNM) Medical Devices is important for meeting the applicable regulatory requirements in India. These requirements may cover manufacturing, import, documentation, quality control, and distribution. The required approval or registration helps businesses show that their products meet applicable requirements and can be safely supplied to healthcare professionals and consumers.
What is BIS Registration for Class A Non-Sterile Non-Measuring (NSNM) Medical Devices?
Non-Sterile Non-Measuring (NSNM) medical devices are generally Class A medical devices under the Medical Devices Rules, 2017. These are low-risk devices supplied in a non-sterile condition without a measuring or monitoring function.
For such devices, the applicable requirement is registration under Chapter IIIB of the Medical Devices Rules, 2017, introduced through the Medical Devices (Sixth Amendment) Rules, 2022. Manufacturers and importers must register applicable devices through the Online System for Medical Devices. After submitting the required details, a system-generated registration number is issued, and no fee is charged.
The registration requires information including the manufacturing site, generic and brand name, model number, intended use, material, dimensions, and shelf life, where applicable. The manufacturer must also provide required undertakings and self-certify compliance with applicable essential principles and standards.
Therefore, the correct term is CDSCO Registration for Class A Non-Sterile and Non-Measuring Medical Devices, not BIS Registration. The applicable devices are identified in the CDSCO classification framework.
Who Can Apply for Registration?
The registration process for Non-Sterile Non-Measuring (NSNM) Medical Devices is mainly applicable to the following:
- Indian Manufacturers: Manufacturers in India who produce Class A medical devices that are supplied in a non-sterile condition and do not have a measuring function can apply for registration.
- Indian Importers: Importers in India who bring eligible Class A non-sterile, non-measuring medical devices from foreign manufacturers can also apply for registration.
The manufacturer or importer must complete the applicable CDSCO registration requirements before placing the device on the Indian market. The registration helps ensure that the medical device meets the applicable Indian regulatory requirements for safety and performance.
CDSCO Regulatory Requirements for NSNM Medical Devices
The Central Drugs Standard Control Organisation (CDSCO) is responsible for regulating medical devices in India. The regulatory framework is mainly governed by the Medical Devices Rules, 2017, which were introduced to ensure that medical devices available in the Indian market meet appropriate requirements for safety, quality, and performance.
Non-Sterile Non-Measuring (NSNM) medical devices are generally classified as Class A medical devices because they are considered low-risk products. These devices are supplied in a non-sterile condition and do not have a measuring function. Compared with Class B, C, and D devices, Class A devices are subject to relatively simpler regulatory requirements because they generally present a lower level of risk.
Manufacturers and importers intending to sell or import eligible NSNM medical devices in India must comply with the applicable CDSCO requirements. For eligible Class A NSNM devices, the regulatory framework provides for registration under Chapter IIIB of the Medical Devices Rules, 2017.
Importance and Benefits of CDSCO Certification for Non-Sterile Non-Measuring
Process of CDSCO Registration for Non-Sterile Non-Measuring (NSNM)
- Determine Device Classification: The first step is to confirm that the medical device qualifies as a Non-Sterile Non-Measuring (NSNM) device and falls under the applicable Class A category based on its intended purpose, risk level, and characteristics.
- Establish Applicant Category: Determine whether the NSNM medical device is manufactured in India or imported from another country. The applicable registration and compliance procedure depends on the applicant category.
- Nominate an Indian Authorized Agent: For imported devices, the overseas manufacturer must appoint an Indian Authorized Agent (IAA). The authorized agent represents the foreign manufacturer before CDSCO and handles the applicable regulatory process in India.
- Compile Required Documentation: Prepare the required documents, including details of the manufacturer or importer, product specifications, intended use, device classification, labeling information, quality-related documents, authorization letters, and other documents applicable to the device.
- Create an Online Account: The applicant should create and maintain an account on the CDSCO online regulatory portal and complete the required organization and applicant details before submitting the application.
- File the Registration Application: Submit the applicable application through the CDSCO online portal in accordance with the regulatory pathway prescribed for Class A NSNM medical devices. Imported devices must be submitted through the applicable import regulatory route, while Indian manufacturers must follow the applicable domestic registration or licensing requirements.
- Pay Applicable Government Fees: Where applicable, pay the prescribed government fee through the designated online payment system and provide the required payment details with the application.
- Regulatory Review: CDSCO or the concerned regulatory authority reviews the submitted information and documents to verify that the device and applicant meet the applicable requirements under the Medical Devices Rules, 2017.
- Address Regulatory Queries: If any deficiency, clarification, or additional information is requested, the applicant must provide the required response and supporting documents within the prescribed timeframe.
- Grant of Registration or Approval: Once the application satisfies the applicable regulatory requirements, the competent authority completes the registration or grants the applicable approval, enabling the applicant to undertake the permitted activities in accordance with Indian medical device regulations.
- Maintain Ongoing Compliance: After registration, the manufacturer or importer must continue to meet applicable requirements relating to product quality, labeling, records, regulatory reporting, post-market obligations, and notification of relevant changes to the device or manufacturing arrangements.
Documents Required for CDSCO License for Non-Sterile Non-Measuring (NSNM) Medical Devices
- Details of the applicant, including name, address, and contact information.
- Details of the manufacturing premises, including the complete manufacturing site address.
- Generic name and description of the medical device.
- Brand name and model number of the device, where applicable.
- Details of the intended use and purpose of the medical device.
- Details of the material of construction, dimensions, and shelf life, where applicable.
- Declaration confirming that the device falls under Class A, non-sterile and non-measuring medical devices.
- Self-certification of conformity with the applicable Essential Principles of Safety and Performance.
- Self-certification confirming compliance with the applicable standards for the medical device.
- For imported devices, details of the importer and overseas manufacturing site.
- Self-attested copy of the overseas manufacturer's establishment or plant registration issued by the competent authority in the country of origin, or a Free Sale Certificate issued by the National Regulatory Authority.
- Undertaking confirming that the information and documents submitted for registration are true and authentic.
- Details of the applicable standards followed for the design, manufacture, and performance of the device.
- Any additional information or documents required by CDSCO based on the specific device and registration application.
Timeline for CDSCO Registration
The timeline for CDSCO registration depends on the device classification, type of application, testing requirements, and completeness of the submitted documents. In general, the process may take 2–6 months or more, depending on the applicable regulatory pathway.
- Document Preparation: 1–3 weeks
- Testing & Technical Documentation: 2–6 weeks
- Application Submission: 1–2 days
- CDSCO Review: 4–12 weeks
- Queries/Clarifications (if any): 2–4 weeks
- Registration/License Approval: After successful review and compliance
Note: The actual timeline may vary depending on the medical device classification, application type, testing requirements, and CDSCO's review process.
Why Choose EVTL India as Your CDSCO Consultant?
Choosing an experienced CDSCO consultant can simplify medical device registration and help reduce regulatory delays.
- Regulatory Expertise: EVTL India has knowledge of the applicable provisions of the Medical Devices Rules, 2017 and provides guidance based on the regulatory requirements applicable to the product.
- Complete Registration Support: We provide end-to-end assistance, from understanding the applicable regulatory pathway and preparing documents to application submission and regulatory follow-up.
- Medical Device Classification Guidance: Correct classification is an important part of CDSCO compliance. Our team helps identify the appropriate classification based on the device's intended use, risk level, and applicable rules.
- Documentation Assistance: We assist in preparing and reviewing the required technical, product, manufacturing, and legal documents to help ensure that the application is complete and properly organized.
- Application and Regulatory Support: Our team helps clients navigate the application process and provides support in addressing regulatory queries or deficiencies that may arise during the review.
- Support for Indian and Foreign Manufacturers: EVTL India assists both Indian manufacturers and overseas manufacturers or importers with their applicable CDSCO regulatory requirements.
Conclusion
CDSCO Registration is important for manufacturers and importers of Non-Sterile Non-Measuring (NSNM) medical devices in India. Proper device classification, documentation, self-certification, labelling, and compliance with applicable requirements help ensure that these devices meet the required safety, quality, and performance standards.
The CDSCO requirements may vary depending on the device and its applicable regulatory classification. Therefore, professional guidance can help businesses understand the correct regulatory pathway, avoid documentation errors, and reduce delays. With 12+ years of experience, EVTL India provides end-to-end support for NSNM medical device compliance, from classification and documentation to registration, application submission, and regulatory support.