CDSCO License for Gastrostomy T fastener
Medical Device Information
Intended Use
A device intended to be inserted into the stomach percutaneously to appose the anterior gastric wall to the anterior abdominal wall, typically to facilitate the insertion of a percutaneous gastrostomy tube or for procedures requiring stabilization/fixation of hollow gastrointestinal (GI) structures.
Comprehensive Guide to CDSCO Licensing for Gastrostomy T Fastener (Class C Medical Device)
Navigating the regulatory landscape for medical devices in India can be complex, especially for specialized devices such as the Gastrostomy T Fastener. This device, categorized under Gastroenterology and classified as Class C by the CDSCO, plays a critical role in stabilizing hollow gastrointestinal structures during percutaneous procedures. With our 25+ years of regulatory experience and having assisted over 500 companies, we provide a detailed roadmap to help you secure your CDSCO license efficiently and compliantly.
Understanding the Gastrostomy T Fastener and Its Regulatory Importance
The Gastrostomy T Fastener is designed for percutaneous insertion into the stomach to appose the anterior gastric wall to the anterior abdominal wall. This facilitates safe insertion of gastrostomy tubes or fixation of GI structures, making it a vital device in gastroenterological interventions. Given its invasive nature and potential impact on patient safety, the CDSCO classifies it as a Class C medical device, necessitating stringent regulatory oversight.
Securing a CDSCO license for this device not only ensures legal market access in India but also reinforces manufacturing quality, safety, and performance standards, ultimately safeguarding patient health.
CDSCO Regulatory Framework for Gastrostomy T Fastener
The Central Drugs Standard Control Organization (CDSCO) governs the import and manufacture of medical devices in India. For Class C devices like the Gastrostomy T Fastener, the MD9 manufacturing license is mandatory and issued by the Central Licensing Authority.
India’s medical device regulations align closely with global best practices, requiring manufacturers to adhere to comprehensive documentation, testing, and audits before granting approval.
Risk Classification and License Requirements for Class C Devices
Class C devices are considered moderate to high risk, involving invasive procedures or critical bodily functions. According to the CDSCO classification:
- License Type: MD9 (Manufacturing License for Class C and D devices)
- Application Form: MD7
- Authority: Central Licensing Authority
- Total Processing Time: Approximately 4-5 months
- Fees: ₹50,000 per application + ₹1,000 per product
For detailed classification criteria, manufacturers can refer to the Medical Device Classification guide.
Manufacturing License Process (MD9) for Gastrostomy T Fastener
The MD9 license application is a multi-step process designed to ensure thorough evaluation:
- Test License (Form MD13): Required prior to full license application, takes about 1.5 to 2 months. Enables product testing in CDSCO-approved labs.
- Product Testing: Conducted at government-recognized labs to verify safety and efficacy.
- Document Preparation: Comprehensive technical dossier including Device Master File, Plant Master File, risk management, and more.
- Submission of Application (Form MD7): Via the CDSCO MD Online Portal.
- Audit by CDSCO Inspectors: Inspection of manufacturing facility and review of QMS.
- Query Resolution: Addressing any observations or requests for additional information.
- Grant of License (Form MD9): Upon successful compliance.
Manufacturers should plan for overlapping timelines where feasible to optimize the overall process duration.
Manufacturing License Documents Required for MD9
Preparing a complete and precise set of documents is critical:
- Company Constitution and Incorporation Certificates
- Proof of Ownership or Lease of Manufacturing Premises
- Technical Staff Qualifications and Experience Details
- Fire and Pollution NOCs
- Device Master File (DMF): Detailed design, specifications, and manufacturing processes. See our Device Master File guide.
- Plant Master File (PMF): Facility layout, equipment, and quality control measures. Refer to our Plant Master File guide.
- Essential Principles Checklist: Compliance with Indian regulations
- Risk Management File: Including hazard analysis and mitigation strategies. Learn more on Risk Management.
- Test Reports from Approved Laboratories: Validating safety and performance
- Labels and Instructions for Use (IFU): In compliance with CDSCO requirements
- Quality Management System (QMS) Documents: Typically ISO 13485:2016 certification
Ensuring all documents are accurate and up-to-date significantly reduces delays.
Import License Process (MD15) for Gastrostomy T Fastener
Importers must obtain an MD15 license before marketing the device in India. The process includes:
- Document Preparation: Including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate (if applicable), DMF, PMF, and wholesale license.
- Application Submission: Form MD14 on the CDSCO MD Online Portal.
- Query Resolution: Timely response to CDSCO queries.
- License Grant: Issued on Form MD15.
The entire process usually takes 5-6 months.
Import License Documents Required
- **Valid Manufacturing License of Exporter
- Free Sale Certificate**
- ISO 13485:2016 Certification
- CE Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale License in India
- Company Constitution and Address Proof
Government fees vary by risk class; for Class C devices, fees are ₹3,000 per site and ₹1,500 per product.
Timeline and Processing Duration
| Process Step | Approximate Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 1 - 1.5 months |
| Document Preparation | Concurrent with testing |
| MD9 Application Submission | Immediate upon readiness |
| Audit and Inspection | 1 - 1.5 months |
| Query Resolution | 2 - 4 weeks |
| Total Time | 4 - 5 months |
Understanding these timelines helps manufacturers plan product launches and inventory accordingly.
Government Fees and Costs Breakdown
- MD9 Manufacturing License: ₹50,000 per application
- Per Product Fee: ₹1,000
- Test License (MD13): Often included or nominal fee
- Testing Charges: Vary based on the complexity and number of tests, typically ₹50,000 to ₹1,50,000
- Audit Costs: Fees payable to notified bodies or CDSCO inspectors
For a detailed fee schedule and advice, consult the MD9 License Guide.
Common Challenges and Practical Solutions
- Incomplete Documentation: Delays often arise from missing or inconsistent documents. Solution: Use detailed checklists and pre-audit reviews.
- Testing Delays: Government labs can have backlogs. Solution: Schedule tests early and consider accredited private labs where permitted.
- Audit Non-Compliance: Facility or QMS shortcomings can lead to audit failures. Solution: Conduct internal audits and mock inspections.
- Query Management: Slow responses can stall approvals. Solution: Assign dedicated regulatory personnel to handle CDSCO communications promptly.
Our hands-on experience enables us to foresee and mitigate these challenges effectively.
Expert Consultation and Support
Given the complexity of Class C device registration, partnering with experienced regulatory consultants is invaluable. We offer:
- End-to-end assistance from test license to final approval
- Preparation of robust Device and Plant Master Files
- Coordination with testing laboratories and notified bodies
- Support during audits and query resolution
Our proven track record with over 500 successful CDSCO registrations ensures your application is handled with precision.
Getting Started with Your CDSCO License Application for Gastrostomy T Fastener
To initiate your CDSCO MD9 license for the Gastrostomy T Fastener:
- Assess your current documentation and manufacturing readiness.
- Apply for the Test License (MD13) via the CDSCO MD Online Portal.
- Coordinate with approved testing laboratories for product evaluation. Explore the list of Testing Laboratories.
- Develop or update your Device Master File and Plant Master File in line with CDSCO requirements.
- Prepare for the manufacturing site audit by reviewing QMS and compliance documentation.
- Submit your MD9 license application (Form MD7) through the portal and monitor for queries.
By following these practical steps and leveraging expert support, you position your Gastrostomy T Fastener for timely regulatory approval and successful entry into the Indian market. For tailored assistance, feel free to reach out to our regulatory team with your specific requirements.
This comprehensive approach ensures your journey from product development to CDSCO approval is smooth, compliant, and efficient.
