CDSCO License for Radionuclide rebreathing system
Medical Device Information
Intended Use
A radionuclide rebreathing system is a device intended to be used to contain a gaseous or volatile radionuclide or a radionuclide-labeled aerosol and permit it to be respired by the patient during nuclear medicine ventilatory tests (testing process of exchange between the lungs and the atmosphere).
Understanding the Radionuclide Rebreathing System and Its Regulatory Importance
Radionuclide rebreathing systems play a critical role in nuclear medicine by facilitating ventilatory tests that assess lung function through the controlled respiration of gaseous or volatile radionuclides. Classified under Interventional Radiology, these devices are inherently complex and carry a significant risk due to their radioactive components. Hence, strict regulatory oversight by the Central Drugs Standard Control Organization (CDSCO) ensures their safety, efficacy, and quality before market entry in India.
With over 25 years of regulatory consultancy expertise and having guided 500+ companies successfully, we understand the nuances of obtaining CDSCO licenses for such high-risk devices. This comprehensive guide focuses on the regulatory framework, licensing pathways, timelines, costs, and documentation specifically tailored for Radionuclide rebreathing systems, classified as Class C medical devices.
CDSCO Regulatory Framework for Radionuclide Rebreathing Systems
As per the CDSCO notification 29/Misc./03/2020-DC (146) dated 26.07.2021, radionuclide rebreathing systems fall under Class C devices due to their invasive nature and involvement of radioactive materials. The regulatory framework mandates manufacturers to obtain a MD9 manufacturing license from the Central Licensing Authority, while importers must secure an MD15 import license.
Manufacturers and importers must comply with requirements laid out under the Medical Device Rules, 2017, including quality management system adherence, technical documentation, and compliance with essential principles.
Risk Classification and License Requirements for Class C Devices
Class C devices, such as the radionuclide rebreathing system, are considered moderate-to-high risk. The licensing requirements involve rigorous assessment by CDSCO, including testing, documentation review, and facility audits.
- Manufacturing License: MD9 license (Application Form MD7) granted by CDSCO Central Licensing Authority.
- Import License: MD15 license (Application Form MD14) granted by CDSCO Central Licensing Authority.
For detailed classification references, manufacturers can consult the Medical Device Classification guide.
Manufacturing License Process (MD9) for Radionuclide Rebreathing Systems
Obtaining an MD9 license for Class C devices typically spans 4-5 months and involves the following sequential steps:
- Test License (Form MD13): Apply for a temporary test license to initiate product testing. This takes approximately 1.5-2 months.
- Product Testing: Conduct mandatory testing at CDSCO-approved laboratories to verify safety and performance. Refer to the list of Testing Laboratories.
- Documentation Preparation: Assemble comprehensive technical files including Device Master File (DMF), Plant Master File (PMF), Risk Management File, and Essential Principles Checklist.
- License Application (Form MD7): Submit the manufacturing license application via the CDSCO MD Online Portal.
- Facility Audit: CDSCO inspectors conduct an on-site audit focusing on QMS compliance, manufacturing processes, and personnel qualifications.
- Query Resolution: Address any queries raised by CDSCO during the evaluation.
- Grant of License (Form MD9): Upon satisfactory review and audit, the MD9 manufacturing license is granted.
Important Notes:
- The audit may be conducted by CDSCO officials without involvement of notified bodies for Class C devices, but it is advisable to check the latest regulations and requirements.
- Real-world experience shows proactive documentation and early engagement with CDSCO inspectors reduce delays.
Manufacturing License Documents Required for MD9
For the Radionuclide rebreathing system, the following documents are critical:
- Company Constitution and Incorporation Certificates
- Proof of Ownership or Lease Agreement for Manufacturing Premises
- Technical Staff Qualifications and Experience Details
- Fire No Objection Certificate (NOC)
- Pollution Control Board NOC
- Device Master File (DMF) – including design, raw materials, and process details (Device Master File Guide)
- Plant Master File (PMF) – detailing manufacturing facility and quality systems (Plant Master File Guide)
- Essential Principles Compliance Checklist
- Risk Management File (per ISO 14971 standards) (Risk Management Tips)
- Test Reports from CDSCO-approved labs
- Labeling and Instructions for Use (IFU) compliant with regulatory requirements
- Quality Management System (QMS) Documents – ISO 13485:2016 certification is highly recommended
Import License Process (MD15) for Radionuclide Rebreathing Systems
Importers seeking to bring radionuclide rebreathing systems into India must apply for an MD15 license, which typically takes 5-6 months. The process includes:
- Document Preparation: Comprehensive dossier including manufacturing license of the foreign manufacturer, Free Sale Certificate, and technical documentation.
- Application Submission: File the application on the CDSCO MD Online Portal.
- Evaluation and Queries: CDSCO reviews documents and may raise questions.
- License Grant: Upon satisfactory review, the MD15 import license is issued.
Notably, the import license process does not require a test license or product testing within India but mandates thorough documentation and proof of compliance from the manufacturing country.
Import License Documents Required for MD15
Key documents include:
- Valid Manufacturing License (MD9 equivalent) from the country of origin
- Free Sale Certificate confirming product is marketed in the exporting country
- ISO 13485:2016 Certificate
- CE Certificate or equivalent international certification
- Device Master File and Plant Master File
- Wholesale License (if applicable)
- Company Constitution and Incorporation Certificates
Timeline and Processing Duration
| License Type | Approximate Duration | Key Milestones |
|---|---|---|
| MD9 Manufacturing | 4-5 months | Test license (1.5-2 months), product testing, audit, license grant |
| MD15 Import | 5-6 months | Document evaluation, query resolution, license grant |
Planning ahead and ensuring complete dossiers can significantly shorten these timelines.
Government Fees and Costs
- MD9 Manufacturing License:
- Application Fee: ₹50,000
- Per Product Fee: ₹1,000
- MD15 Import License:
- For Class C devices, Fee per site: $3,000
- Fee per product: $1,500
Fees are payable online through the CDSCO portal during application submission.
Common Challenges and Practical Solutions
Challenge: Delays due to incomplete documentation or non-compliance with essential principles.
Solution: Engage regulatory experts to pre-review documents and ensure alignment with CDSCO expectations. Utilize checklists and templates from trusted sources.
Challenge: Lengthy product testing and audit scheduling.
Solution: Coordinate early with CDSCO-approved testing labs and schedule audits proactively. Maintain a compliant QMS to facilitate smooth audits.
Challenge: Complexities in risk management file preparation.
Solution: Adopt ISO 14971 principles and document risk analysis, evaluation, control measures, and residual risk justification thoroughly.
Expert Consultation and Support
Navigating CDSCO licensing for high-risk devices like radionuclide rebreathing systems demands technical expertise and regulatory know-how. Our seasoned consultants provide tailored support — from dossier preparation and audit readiness to timely query resolution. We ensure your application stands strong for swift approvals.
Getting Started with Your CDSCO License Application
- Assess Your Device Classification: Confirm your device’s risk class using the Medical Device Classification resource.
- Prepare Your Technical Documentation: Begin assembling your DMF, PMF, Risk Management File, and QMS documents.
- Apply for Test License (MD13): If manufacturing, initiate the test license application through the CDSCO MD Online Portal.
- Engage with Approved Testing Laboratories: Schedule necessary product testing early.
- Plan for Audit: Prepare your manufacturing site and QMS for CDSCO inspection.
- Submit License Application: Use the MD7 form for manufacturing or MD14 for import via the CDSCO portal.
Our team is ready to assist you through each step, ensuring compliance and minimizing time to market. Connect with us to leverage our 25+ years of expertise and join the cohort of 500+ satisfied medical device innovators in India.
For detailed guides on MD9 manufacturing and MD15 import licenses, visit our comprehensive resources: MD9 License Guide, and Import License Guide.
