CDSCO License for Gastrointestinal anastomosis coupler, bioabsorbable
Medical Device Information
Intended Use
An implantable device intended to be used to join and transect excess tissue of gastrointestinal structures through the coupling of two ring-shaped components that are inserted into the ends of the segments to be attached.
Comprehensive Guide to CDSCO Licensing for Gastrointestinal Anastomosis Coupler (Bioabsorbable) – Class D Medical Device
As seasoned regulatory consultants with over 25 years in the Indian medical device sector, having successfully guided 500+ companies through the CDSCO licensing maze, we understand the nuances involved in bringing high-risk implantable devices like the bioabsorbable gastrointestinal anastomosis coupler to the Indian market. This device, classified as Class D under the CDSCO framework, requires rigorous compliance due to its critical role in joining and transecting gastrointestinal tissues through dual ring-shaped components.
Understanding the CDSCO Regulatory Framework for Gastrointestinal Anastomosis Coupler
The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India. Devices are regulated based on risk classification from Class A (low risk) to Class D (highest risk). Your device, notified under Notification 29/Misc./03/2020-DC (182) dated 27.09.2021, falls under Class D – the highest risk category due to its implantable nature and critical clinical use in gastroenterology.
Class D devices necessitate a stringent approval process involving the Central Licensing Authority, comprehensive documentation, robust quality management systems, and compliance with essential principles of safety and performance.
Risk Classification and License Requirements for Class D Devices
Class D devices require an MD9 manufacturing license, which is granted by the CDSCO's Central Licensing Authority. The MD9 license application process involves detailed scrutiny of manufacturing facilities, technical expertise, product safety, and clinical evaluation.
Key points:
- License Type: MD9 (Application Form MD7)
- Authority: Central Licensing Authority
- Typical Timeline: 4 to 5 months
- Fees: ₹50,000 per application + ₹1,000 per product
Step-by-Step Manufacturing License Process (MD9) for Class D Gastrointestinal Anastomosis Coupler
Test License Application (Form MD13):
- Duration: Approximately 1.5 to 2 months
- Purpose: Allows product testing in government-approved labs
- Important: Testing must be completed in CDSCO-recognized labs; consult the Testing Laboratories list for options.
Product Testing:
- Conduct rigorous testing covering biocompatibility, mechanical integrity, sterility, and performance per relevant Indian and international standards.
Document Preparation:
- Prepare comprehensive dossiers including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and QMS documentation.
- Utilize our detailed Device Master File Guide and Plant Master File Guide for reference.
MD9 License Application Submission:
- Submit Form MD7 along with all required documents through the CDSCO MD Online Portal.
Audit by CDSCO Inspectors:
- A thorough on-site audit of manufacturing premises and QMS compliance is conducted.
- Prepare for queries and inspections by reviewing your audit readiness proactively.
Resolution of Queries:
- Address any clarifications raised by CDSCO promptly to avoid delays.
Grant of MD9 License:
- Upon successful review and audit, CDSCO grants the MD9 license on Form MD9.
Essential Documents Required for MD9 License Application
- Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
- Proof of Ownership or Lease of Manufacturing Premises
- Details and qualifications of Technical Staff
- Fire NOC and Pollution Control Board NOC
- Device Master File detailing design, specifications, and manufacturing processes
- Plant Master File outlining manufacturing facilities and processes
- Essential Principles Checklist demonstrating compliance with safety and performance standards
- Risk Management File aligned with ISO 14971 principles
- Test Reports from CDSCO-approved laboratories
- Product labels, packaging, and Instructions for Use (IFU)
- Quality Management System documents (preferably ISO 13485:2016 certified)
Import License Process (MD15) for Gastrointestinal Anastomosis Coupler
If you plan to import this device, an MD15 import license from the Central Licensing Authority is mandatory. The process involves:
- Submission of manufacturing license from the country of origin
- Free Sale Certificate
- ISO 13485:2016 and CE Certificate
- Device and Plant Master Files
- Wholesale license
The import license usually takes 5 to 6 months, with fees varying by device class (Class D import fees approx 1500 per product). Applications are submitted via the CDSCO MD Online Portal.
Timeline and Processing Duration Overview
| Stage | Estimated Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 1 – 1.5 months |
| Documentation Prep | Concurrent with testing |
| MD9 License Processing | 2 – 3 months |
| Total Estimated Time | 4 – 5 months |
Government Fees and Costs
- MD13 Test License: Included in subsequent applications
- MD9 Manufacturing License: ₹50,000 per application + ₹1,000 per product
- Additional costs: Testing fees at government-approved labs, audit readiness expenses, potential consultancy fees
Common Challenges and Practical Solutions
Challenge 1: Delay in test report availability
- Solution: Engage early with CDSCO-approved testing laboratories and plan testing schedules meticulously.
Challenge 2: Audit non-compliance due to incomplete QMS
- Solution: Implement a robust Quality Management System aligned with ISO 13485, and conduct internal audits before CDSCO inspection.
Challenge 3: Documentation gaps, particularly in Risk Management
- Solution: Develop a detailed Risk Management File per ISO 14971 guidelines to demonstrate proactive hazard control.
Challenge 4: Slow query response times
- Solution: Assign dedicated regulatory personnel to monitor and promptly respond to CDSCO queries.
Expert Consultation and Support
Navigating the complexities of CDSCO licensing for Class D implantable devices demands expertise. Our proven methodology includes:
- In-depth gap analysis
- Comprehensive document preparation
- Audit readiness coaching
- Liaison with CDSCO and notified bodies
Our extensive experience has empowered numerous clients to secure their MD9 licenses efficiently and compliantly.
Getting Started with Your CDSCO License Application
Evaluate Device Classification: Confirm your device’s Class D status via CDSCO notifications and classification guides like Medical Device Classification.
Initiate Test License Application: Apply for the test license (Form MD13) through the CDSCO MD Online Portal.
Engage Testing Labs: Coordinate with CDSCO-approved labs to schedule product testing.
Prepare Documentation: Concurrently begin compiling your Device Master File, Plant Master File, and supporting documents.
Plan for Audit: Align your manufacturing processes and QMS to CDSCO requirements and schedule internal audits.
Submit MD9 Application: Once test reports are in hand, submit the MD9 license application (Form MD7) online.
Respond to Queries Promptly: Maintain proactive communication with CDSCO to expedite processing.
Embarking on this journey with a clear roadmap and expert support significantly enhances your chances of timely approval. Reach out to our consultancy to leverage our decades of experience and streamline your CDSCO licensing for your bioabsorbable gastrointestinal anastomosis coupler.
