CDSCO License for Fistula-repair biomatrix implant
Medical Device Information
Intended Use
A sterile, bioabsorbable, animal-derived substance intended to be injected into a fistula tract (e.g., anal or rectal fistula) to close it by adding volume and promoting the ingrowth and neovascularization of host tissue.
Comprehensive Guide to CDSCO Licensing for Fistula-Repair Biomatrix Implant (Class D Medical Device)
As a trusted regulatory consultancy with over 25 years of experience helping 500+ medical device companies, we understand the unique challenges manufacturers and importers face when navigating India's CDSCO licensing system. This guide focuses on the Fistula-repair biomatrix implant—a Class D, high-risk gastroenterology device—and provides detailed, actionable insights on obtaining the necessary CDSCO license to legally manufacture or import this advanced implant in India.
Understanding the Fistula-Repair Biomatrix Implant and Regulatory Importance
The Fistula-repair biomatrix implant is a sterile, bioabsorbable, animal-derived substance designed to be injected into fistula tracts, such as anal or rectal fistulas. Its function is to close the fistula by adding volume and facilitating host tissue ingrowth and neovascularization. Given its implantable nature and critical role in treating complex gastroenterological conditions, the device is classified as Class D under CDSCO regulations—signifying the highest risk category.
Class D devices undergo stringent regulatory scrutiny to ensure patient safety and device efficacy. Compliance with CDSCO's framework is mandatory before marketing or manufacturing this implant in India.
CDSCO Regulatory Framework for Fistula-Repair Biomatrix Implant
India’s Central Drugs Standard Control Organization (CDSCO) regulates medical devices through a risk-based classification system, aligning with global standards. For Class D devices like the Fistula-repair biomatrix implant, the license is issued by the Central Licensing Authority (CLA), and the process entails rigorous testing, documentation, and audits.
The device falls under the gastroenterology category as notified by CDSCO Notification 29/Misc./03/2020-DC (182) dated 27.09.2021, confirming its classification and regulatory requirements.
Risk Classification and License Requirements for Class D Devices
- Risk Class: D (High Risk)
- License Type: MD9 Manufacturing License (Form MD7)
- Authority: Central Licensing Authority (CLA), CDSCO
- Process Duration: Approximately 4-5 months (including test license, product testing, documentation, audit, and query resolution)
Step-by-Step Manufacturing License Process for MD9
Test License Application (Form MD13):
- Before the manufacturing license, apply for a Test License to manufacture and test the device prototypes.
- Duration: 1.5 to 2 months.
- This allows sampling and testing in government-approved laboratories.
Product Testing:
- Test the implant for safety, biocompatibility, sterility, and other parameters through CDSCO-approved labs.
- Refer to the Testing Laboratories list for accredited facilities.
Document Preparation:
- Compile all technical and quality documents, including Device Master File and Plant Master File.
MD9 License Application (Form MD7):
- Submit the application via the CDSCO MD Online Portal.
CDSCO Inspection and Audit:
- CDSCO inspectors conduct audits to verify compliance with QMS standards and regulatory requirements.
Query Resolution:
- Address any queries raised by CDSCO during the review.
Grant of License (Form MD9):
- Upon successful compliance, the MD9 manufacturing license is issued.
Manufacturing License Documents Required for Fistula-Repair Biomatrix Implant
- Company constitution documents (incorporation certificate, MOA/AOA)
- Proof of ownership or lease of manufacturing premises
- Detailed Device Master File (refer to our comprehensive Device Master File guide)
- Plant Master File with facility details (Plant Master File Guide)
- Qualification documents for technical staff
- Fire safety and pollution control clearances (NOCs)
- Risk Management File compliant with ISO 14971 (Risk Management Guide)
- Essential Principles Checklist demonstrating conformity with safety and performance requirements
- Test reports from government-approved labs
- Product labels and Instructions for Use (IFU)
- Quality Management System documentation (ISO 13485:2016 compliance)
Import License Process (MD15) for Fistula-Repair Biomatrix Implant
For importers intending to bring this implant into India, the MD15 Import License granted by CDSCO’s Central Licensing Authority is mandatory.
- Application Form: MD14
- Process Duration: 5 to 6 months
- Documents Required:
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 certification
- CE Certificate or equivalent
- Device and Plant Master Files
- Wholesale Drug License (if applicable)
- Company incorporation details
- Fees:
- Class D devices: ₹2,25,000 per site + ₹1,12,500 per product (converted approx. from USD fees)
- Application submission is also through the CDSCO MD Online Portal.
Timeline and Processing Duration
| Process Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 1 - 1.5 months |
| Document Preparation | 2 - 3 weeks |
| MD9 License Application | 1 week |
| CDSCO Audit and Review | 1 - 1.5 months |
| Query Resolution & Grant | 2 - 3 weeks |
Total estimated time: Approximately 4 to 5 months.
Government Fees and Costs
- MD9 Manufacturing License:
- Application fee: ₹50,000
- Per product fee: ₹1,000
- Test License:
- Separate fees applicable during test license application
- Additional Costs:
- Testing laboratory fees vary depending on test scope
- Audit fees if engaging a notified body
Common Challenges and Practical Solutions
Challenge 1: Complex Documentation
- The volume and technical nature of required documents can cause delays.
- Solution: Utilize detailed templates and expert guidance to prepare Device and Plant Master Files accurately. Our MD9 License Guide includes checklists and examples.
Challenge 2: Product Testing Delays
- Limited availability of government-approved labs can prolong testing.
- Solution: Plan testing early and select labs from the official Testing Laboratories list.
Challenge 3: Audit Non-Compliance
- Insufficient QMS implementation may lead to negative audit outcomes.
- Solution: Conduct internal audits and corrective actions before CDSCO inspection.
Challenge 4: Regulatory Updates
- Keeping pace with evolving CDSCO guidelines can be overwhelming.
- Solution: Partner with experienced consultants who monitor real-time regulatory changes.
Expert Consultation and Support
Navigating the CDSCO licensing pathway for Class D devices like the Fistula-repair biomatrix implant requires specialized expertise. With our extensive track record of successful approvals, we offer tailored support including:
- Gap analysis and readiness assessment
- Document preparation and review
- Coordination with notified bodies and testing labs
- Pre-audit training and mock audits
- Regulatory liaison and query management
Getting Started with Your CDSCO License Application
Step 1: Determine your device classification and verify applicability of Class D via the Medical Device Classification resource.
Step 2: Register and submit your initial Test License application (Form MD13) on the CDSCO MD Online Portal.
Step 3: Initiate product testing promptly to adhere to timelines.
Step 4: Begin compiling your Device Master File, Plant Master File, and Risk Management File in parallel.
Step 5: Engage with our consultants early to streamline documentation and prepare for the CDSCO audit.
Embarking on your regulatory journey with expert guidance and a structured plan ensures a smoother path to market entry for your Fistula-repair biomatrix implant. Contact us today to leverage our 25+ years of regulatory expertise and join the 500+ companies we have successfully assisted.
