CDSCO License for Gastrointestinal anastomosis coupler, non- 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 CDSCO Licensing Guide for Gastrointestinal Anastomosis Coupler (Non-Bioabsorbable)
As a medical device manufacturer or importer aiming to enter the Indian market with a gastrointestinal anastomosis coupler (non-bioabsorbable) classified as a Class C device, understanding the CDSCO regulatory landscape is crucial. With over 25 years of experience and having supported 500+ companies in securing CDSCO licenses, we provide a detailed, practical roadmap focused on your device’s regulatory requirements.
Introduction: Device Overview and Regulatory Importance
The gastrointestinal anastomosis coupler is an implantable device used to join and transect excess gastrointestinal tissue by coupling two ring-shaped components inserted into the ends of the segments. Given its implantable nature and critical use in gastrointestinal surgeries, it carries a Class C risk classification under CDSCO’s framework, necessitating stringent regulatory compliance to ensure patient safety and market authorization.
Obtaining the appropriate CDSCO license not only fulfills legal obligations but also builds trust with healthcare providers and end-users in India’s growing medical device market.
CDSCO Regulatory Framework for Gastrointestinal Anastomosis Coupler
Medical devices in India are regulated by the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health & Family Welfare. Devices are categorized by risk classes A through D, with Class C devices like your gastrointestinal anastomosis coupler requiring a central licensing authority approval.
Your device falls under notified category 29/Misc./03/2020-DC (182) with the notification date of 27.09.2021, which mandates compliance with specific regulatory controls including quality management system (QMS) adherence, clinical evaluation, and audit by CDSCO inspectors.
Risk Classification and License Requirements
- Risk Class: C
- License Type: MD9 Manufacturing License (Application Form MD7)
- Authority: Central Licensing Authority (CDSCO HQ, New Delhi)
Class C devices entail moderate to high risk, requiring thorough product testing, documentation, and inspection before license approval.
Manufacturing License Process (MD9)
The MD9 license process is multi-phased and comprehensive:
Apply for Test License (Form MD13): Before manufacturing license application, you must secure a test license allowing limited-scale production for testing purposes. This takes approximately 1.5 to 2 months.
Product Testing: Conduct product testing at CDSCO-approved laboratories to verify safety and efficacy. Testing duration varies but typically spans 4 to 6 weeks.
Document Preparation: Compile required technical and quality documents, including Device Master File and Plant Master File.
Apply for MD9 License (Form MD7): Submit the application via the CDSCO MD Online Portal with all supporting documents.
Audit by CDSCO Inspectors: An on-site audit of your manufacturing facility and QMS compliance is conducted.
Query Resolution: Address any queries or observations raised during audit or document review.
License Grant: Upon satisfactory compliance, the MD9 manufacturing license is issued.
For detailed guidance, our MD9 License Guide offers step-by-step insights.
Manufacturing License Documents Required
To ensure seamless application, prepare the following documents:
- Company Constitution (Memorandum & Articles of Association)
- Proof of Ownership or Lease of Premises
- Details and Qualifications of Technical Staff
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF) outlining device specifications, design, and manufacturing process (DMF Guide)
- Plant Master File (PMF) documenting manufacturing facilities and quality controls (PMF Guide)
- Essential Principles Checklist demonstrating compliance with safety and performance standards
- Risk Management File covering hazard analysis, risk evaluation, and mitigation (Risk Management)
- Test Reports from CDSCO-approved laboratories (Testing Laboratories)
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents, preferably ISO 13485:2016 certified
Import License Process (MD15)
If you plan to import the gastrointestinal anastomosis coupler, an MD15 import license is mandatory.
Process highlights:
- No test license required for import
- Submit application on Form MD14 via CDSCO MD Online Portal
- Provide manufacturing license from the country of origin
- Provide Free Sale Certificate and CE Certificate
- Include Device Master File, Plant Master File, and Wholesale License
- Respond promptly to any CDSCO queries
The import license process typically takes 5 to 6 months due to detailed scrutiny.
For more details, consult our Import License Guide.
Import License Documents Required
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certificate
- CE Certificate or Equivalent
- Device Master File and Plant Master File
- Wholesale Drug License (if applicable)
- Company Constitution
Timeline and Processing Duration
| License Type | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 1 - 1.5 months |
| MD9 Manufacturing License | 4 - 5 months (total) |
| MD15 Import License | 5 - 6 months |
Note: The MD9 duration includes test license issuance, product testing, documentation, audit, query resolution, and license grant.
Government Fees and Costs
| License Type | Fees |
|---|---|
| MD9 Application Fee | Rs. 50,000 per application |
| Product Fee | Rs. 1,000 per product |
| Test License (MD13) Fee | Rs. 5,000 approx. |
| MD15 Import License Fee | Class C & D: 1,500/product |
These fees are payable online through the CDSCO portal. Plan your budget accordingly to avoid delays.
Common Challenges and Solutions
- Incomplete Documentation: Missing or insufficient technical files cause rejection. Solution: Use a detailed checklist and consult experts.
- Delayed Product Testing: Testing labs have limited capacity. Solution: Pre-book slots with CDSCO-approved labs.
- Audit Non-compliance: Facility gaps can cause audit failures. Solution: Conduct internal audits and gap assessments before CDSCO inspection.
- Slow Query Responses: Delayed replies extend timelines. Solution: Maintain a dedicated regulatory team for prompt communication.
Expert Consultation and Support
Navigating CDSCO regulations for Class C devices demands expertise. Our consultancy, with a track record of 500+ successful licenses, offers:
- Customized regulatory strategy
- Document preparation and review
- Coordination with notified bodies and CDSCO inspectors
- Training for internal teams
- End-to-end application management
Contact us early in your product lifecycle to streamline approvals.
Getting Started with Your CDSCO License Application
Assess Device Classification: Confirm Class C status via the Medical Device Classification tool.
Prepare Test License Application: Gather documents and submit Form MD13 through the CDSCO MD Online Portal.
Engage CDSCO-Approved Testing Labs: Schedule testing for your device.
Compile Complete Documentation: Device Master File, Plant Master File, QMS, risk management, and others.
Apply for MD9 License: Submit Form MD7 with all attachments.
Prepare for Audit: Ensure manufacturing compliance and readiness.
Respond to Queries: Address all CDSCO and audit findings promptly.
Obtain License and Commence Manufacturing: Upon license grant, you can legally manufacture and market your device in India.
Starting early and partnering with experienced regulatory consultants can dramatically reduce timelines and increase your chances of success.
For personalized assistance, reach out to our team who have guided numerous companies through the CDSCO licensing maze for implantable Class C devices like gastrointestinal anastomosis couplers.
By following this expert roadmap, manufacturers and importers can confidently navigate the CDSCO licensing process, ensuring timely market entry and regulatory compliance for this critical gastroenterology device.
