CDSCO License for Foetal pleuro-amniotic catheter
Medical Device Information
Intended Use
Sterile implantable device used to continuously drain fetal pleural effusion to maternal amniotic cavity.
Understanding the Foetal Pleuro-Amniotic Catheter and Its Regulatory Significance
The Foetal pleuro-amniotic catheter is a critical sterile implantable medical device designed to continuously drain fetal pleural effusion into the maternal amniotic cavity. Classified under the obstetrical and gynecological category, this device plays a vital role in fetal therapy and requires stringent regulatory oversight given its direct implantation and life-supporting function.
In India, regulatory compliance for such devices is governed by the Central Drugs Standard Control Organization (CDSCO), ensuring safety, efficacy, and quality before market entry. For manufacturers and importers, understanding the CDSCO licensing pathway for a Class C device like the Foetal pleuro-amniotic catheter is essential to streamline approvals and avoid common pitfalls.
CDSCO Regulatory Framework for Foetal Pleuro-Amniotic Catheters
The CDSCO classifies medical devices into four risk classes: A, B, C, and D. Your device, being Class C, demands a higher level of scrutiny due to its medium-to-high risk profile. Regulatory oversight for Class C devices falls under the Central Licensing Authority, which administers the MD9 manufacturing license process for domestic manufacturers and the MD15 import license process for foreign manufacturers or importers.
The device is notified under File No. 29/Misc./03/2020-DC (181) dated 03.6.2022, confirming its inclusion in the regulatory ambit of CDSCO.
Risk Classification and License Requirements for Class C Devices
Class C devices, like the Foetal pleuro-amniotic catheter, require:
- MD9 License (Manufacturing License): For Indian manufacturers, application via Form MD7.
- MD15 License (Import License): For importers, application via Form MD14.
Both licenses necessitate comprehensive documentation, product testing, audits, and compliance with quality management systems aligned with ISO 13485:2016.
Manufacturing License Process (MD9) for Foetal Pleuro-Amniotic Catheters
- Test License (Form MD13): Before applying for the full manufacturing license, manufacturers must obtain a Test License, taking approximately 1.5 to 2 months.
- Product Testing: Samples tested at CDSCO-approved laboratories to verify conformity. Refer to the list of testing laboratories for accredited options.
- Document Preparation: Compile technical files including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and QMS documentation.
- Application Submission: Apply for the MD9 license using Form MD7 via the CDSCO MD Online Portal.
- Audit: CDSCO inspectors conduct a thorough audit of manufacturing premises and quality systems.
- Query Resolution: Address any clarifications or deficiencies raised by the authority.
- License Grant: Upon satisfactory review, the MD9 license is issued on Form MD9.
Overall, the MD9 licensing process spans approximately 4 to 5 months.
Manufacturing License Documents Required
- Company constitution and registration certificates
- Proof of ownership or lease of manufacturing premises
- Details and qualifications of technical staff
- Fire and pollution NOCs
- Device Master File (detailed design and specifications) — our comprehensive Device Master File guide explains best practices
- Plant Master File — see our Plant Master File guide
- Essential Principles Checklist
- Risk Management File aligned with ISO 14971 — learn more about medical device risk management
- Product test reports from CDSCO-approved labs
- Labeling and Instructions for Use (IFU)
- Quality Management System documents (ISO 13485:2016 compliance)
Import License Process (MD15) for Foetal Pleuro-Amniotic Catheters
Importers must follow the MD15 license pathway:
- Document Preparation: Gather all mandatory documents including manufacturing license, free sale certificate, ISO 13485:2016 certification, CE certificate, Device and Plant Master Files.
- Application Submission: Apply on Form MD14 through the CDSCO MD Online Portal.
- Review and Query Resolution: The Central Licensing Authority evaluates submissions and may seek clarifications.
- License Issuance: Upon compliance, the MD15 import license is granted.
The import license process typically takes 5 to 6 months.
Import License Documents Required
- Valid manufacturing license from the country of origin
- Free Sale Certificate confirming market approval
- ISO 13485:2016 certification
- CE Certificate or equivalent regulatory approval
- Device Master File
- Plant Master File
- Wholesale license for distribution
- Company constitution and registration documents
Timeline and Processing Duration
| License Type | Process Steps | Average Duration |
|---|---|---|
| MD9 Manufacturing | Test License → Testing → Audit → License | 4 to 5 months |
| MD15 Import | Document review → Query resolution → License | 5 to 6 months |
Planning for additional time for documentation readiness and potential queries is advisable.
Government Fees and Costs
- MD9 License Fees: INR 50,000 per application + INR 1,000 per product.
- MD15 Import License Fees: For Class C devices, USD 3,000 per site + USD 1,500 per product.
Additional costs include fees for testing at accredited laboratories and notified body audits.
Common Challenges and Solutions
- Delayed Testing Results: To avoid bottlenecks, pre-select CDSCO-approved labs early and confirm test scope.
- Incomplete Documentation: Use checklists and expert consultations to ensure comprehensive submissions.
- Audit Non-Compliance: Conduct internal mock audits before CDSCO inspection.
- Query Management: Maintain prompt communication with CDSCO to resolve queries efficiently.
Expert Consultation and Support
With over 25 years of regulatory experience and having supported more than 500 companies, we provide tailored consultancy for Foetal pleuro-amniotic catheter manufacturers and importers. Our services include document preparation, audit readiness, application submission, and liaison with CDSCO to expedite approvals.
Getting Started with Your CDSCO License Application
- Assess Classification and Licensing Needs: Confirm your device is Class C and understand the MD9 or MD15 license requirements.
- Prepare Essential Documentation: Initiate compilation of Device and Plant Master Files, Risk Management, and quality certifications.
- Engage Testing Laboratories Early: Schedule product testing with CDSCO-approved labs.
- Apply for Test License (MD9 only): Submit Form MD13 to begin manufacturing license process.
- Utilize the CDSCO MD Online Portal for all submissions: This ensures a transparent and trackable application process.
- Plan for Audits and Queries: Organize your team and documentation for smooth inspections and quick response.
By following these actionable steps and leveraging expert guidance, manufacturers and importers can efficiently navigate the CDSCO licensing pathway for Foetal pleuro-amniotic catheters, ensuring timely market access and regulatory compliance.
