CDSCO License for Nitrogen monoxide analyser

Comprehensive Guide to CDSCO Licensing for Nitrogen Monoxide Analyser (Class B Respiratory Device)

As seasoned regulatory consultants with over 25 years of experience and having successfully supported more than 500 medical device companies, we understand the unique challenges manufacturers and importers face in obtaining CDSCO licenses. This detailed guide focuses on the Nitrogen Monoxide Analyser, a Class B respiratory device designed to measure nitric oxide (NO) in exhaled air for asthma diagnosis and management, notified under File No. 29/Misc/03/2020-DC(197) on 6.8.2021.

CDSCO Regulatory Framework for Nitrogen Monoxide Analyser

The Central Drugs Standard Control Organization (CDSCO) classifies medical devices based on risk. The Nitrogen Monoxide Analyser falls under Class B (low-moderate risk), governed by the Ministry of Health and Family Welfare. Compliance with CDSCO regulations ensures safety, efficacy, and quality, critical for patient care in respiratory diagnostics.

CDSCO mandates that manufacturers obtain a Manufacturing License (MD5) from the State Licensing Authority and importers secure an Import License (MD15) from the Central Licensing Authority.

Risk Classification and License Requirements for Class B Devices

• Risk Class: B (Low-moderate risk)
• License Required: MD5 for manufacturing, MD15 for import
• Governing Authority: State Authority for MD5, Central Authority for MD15
• Notification Details: File No. 29/Misc/03/2020-DC(197), dated 06-Aug-2021

For a comprehensive understanding of device classification, refer to our Medical Device Classification guide.

Manufacturing License Process (MD5) for Nitrogen Monoxide Analyser

The MD5 license process is a multi-step procedure taking approximately 3 to 4 months. The steps include:

1. Test License Application (Form MD13): Submit an application for a test license, which takes about 1.5 to 2 months for approval.
2. Product Testing: Obtain product testing reports from CDSCO-approved government laboratories. You can check the list of testing laboratories authorized to conduct such tests.
3. Document Preparation: Compile necessary technical documents such as Device Master File, Plant Master File, Risk Management File, etc.
4. Application Submission for MD5 License (Form MD3): Apply through the CDSCO MD Online Portal.
5. Audit by Notified Body: Undergo a mandatory audit by a CDSCO-recognized notified body. You may view the list of notified bodies for audit services.
6. Query Resolution: Address any queries raised by the department or auditors.
7. License Grant: Upon satisfactory review, the MD5 license is granted.

Manufacturing License Documents Required

Accurate and complete documentation is crucial to avoid delays. For the Nitrogen Monoxide Analyser, the following are mandatory:

• Company Constitution and Incorporation Certificate
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Qualifications and Experience Documents of Technical Staff
• Fire NOC and Pollution Control NOC
• Device Master File (DMF): Detailed technical specifications and design data. Our Device Master File guide offers step-by-step assistance.
• Plant Master File (PMF): Details of manufacturing facilities and quality systems. Refer to our Plant Master File guide for best practices.
• Essential Principles Checklist confirming compliance with safety and performance standards
• Risk Management File as per ISO 14971 standards. Learn more in our Risk Management resource.
• Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents, preferably ISO 13485:2016 certified

Import License Process (MD15) for Nitrogen Monoxide Analyser

Importers must apply for an MD15 license, which typically takes 5 to 6 months. The process involves:

1. Document Preparation: Compile manufacturing license, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files, Wholesale License, and Company Constitution.
2. Application Submission (Form MD14): File the application through the CDSCO MD Online Portal.
3. Query Resolution: Promptly respond to any department queries.
4. License Issuance: Upon compliance verification, the MD15 license is granted.

Import License Documents Required

• Valid Manufacturing License of the device from the country of origin
• Free Sale Certificate issued by the respective health authority
• ISO 13485:2016 Certificate
• CE Certificate or equivalent international regulatory approval
• Device Master File and Plant Master File
• Wholesale Drug License (if applicable)
• Company Constitution and Incorporation Papers

Timeline and Processing Duration

Government Fees and Costs

• MD5 License Fees: Rs. 5,000 per application + Rs. 500 per product
• MD15 Import License Fees (Class B devices): $2,000 per site +$1,000 per product

These fees are payable online via the CDSCO portal during application submission.

Common Challenges and Practical Solutions

• Delays in Product Testing: Coordinate early with CDSCO-approved labs to schedule tests. Consider labs with prior experience in respiratory devices.
• Incomplete Documentation: Use a document checklist to ensure all mandatory files like Device Master File and Risk Management File are complete and up-to-date.
• Audit Non-compliance: Conduct pre-audit internal reviews and gap assessments to prepare for notified body audits.
• Query Resolution Delays: Assign dedicated regulatory personnel to respond promptly to CDSCO queries.

Expert Consultation and Support

With our extensive experience assisting over 500 companies, we offer tailored consultancy to streamline your CDSCO licensing journey. From document preparation to audit readiness and query management, our experts ensure timely approvals with minimal hassle.

Getting Started with Your CDSCO License Application for Nitrogen Monoxide Analyser

1. Evaluate Your Product Classification and Confirm Risk Class B.
2. Register on the CDSCO MD Online Portal if not already done.
3. Apply for the Test License (Form MD13) immediately to avoid initial delays.
4. Arrange for Product Testing at an approved laboratory; coordinate logistics early.
5. Prepare Comprehensive Documentation including DMF, PMF, Risk Management, and QMS files.
6. Schedule the Notified Body Audit once the test reports and documents are ready.
7. Submit the MD5 License Application (Form MD3) on the portal.
8. Maintain Active Communication with CDSCO to swiftly address any queries.

For detailed guidance on MD5 license application, consult our MD5 License guide, and for import licensing, see our Import License guide.

Embarking on your CDSCO licensing journey for the Nitrogen Monoxide Analyser with a clear roadmap and expert support will smoothen market entry and foster regulatory compliance essential for success in India’s growing medical device sector.