CDSCO License for Pancreatic stent

Comprehensive CDSCO Licensing Guide for Pancreatic Stents (Class C Medical Device)

Pancreatic stents, vital in managing chronic pancreatitis by maintaining duct patency, fall under the Class C category of medical devices in India. Given their critical clinical role and inherent risk profile, navigating the CDSCO regulatory framework for pancreatic stents requires precise knowledge and adherence to detailed procedures. With over 25 years of regulatory consulting experience and having supported 500+ companies in medical device approvals, we provide you with an in-depth, practical roadmap for obtaining your CDSCO manufacturing (MD9) and import (MD15) licenses.

CDSCO Regulatory Framework for Pancreatic Stents

As per the official notification 29/Misc/3/2017-DC (292) dated 06.06.2018, pancreatic stents are classified as Class C devices under the “Catheters” category by CDSCO. This classification places them in a moderate to high risk bracket, subjecting manufacturers to central licensing authority oversight, stringent documentation, and testing standards.

Risk Classification and License Requirements

• Device Risk Class: Class C
• Intended Use: Placement in pancreatic ducts for chronic pancreatitis management
• Regulatory Implication: Requires MD9 manufacturing license (Central Licensing Authority) and MD15 import license for foreign manufacturers or importers.

For full details on medical device classification, refer to our guide on Medical Device Classification.

Manufacturing License Process (MD9) for Pancreatic Stents

The MD9 license is mandatory for manufacturing Class C devices and involves multiple stages:

1. Test License (Form MD13): Before applying for MD9, you must obtain a test license for stability and performance evaluation. This process typically takes 1.5 to 2 months.

2. Product Testing: Conduct mandatory product testing at CDSCO-approved laboratories. Testing covers biocompatibility, mechanical integrity, and sterilization validation. Reference the updated list of Testing Laboratories.

3. Documentation Preparation: Compile comprehensive documentation including Device Master File, Plant Master File, and Risk Management File.

4. Application Submission (Form MD7): Submit your MD9 application via the CDSCO MD Online Portal.

5. Audit by CDSCO Inspectors: Expect a thorough audit focusing on quality management systems (ISO 13485), manufacturing processes, and compliance with Essential Principles.

6. Resolution of Queries: Address any observations or deficiencies raised during the audit promptly.

7. Grant of License: Upon satisfactory review, the Central Licensing Authority issues the MD9 license.

For a detailed walkthrough, explore our MD9 License Guide.

Manufacturing License Documents Required

To streamline your application, ensure you have the following documents ready:

• Company Constitution and Incorporation Certificates
• Proof of Premises Ownership or Lease Agreement
• Qualification Documents of Technical Personnel
• Fire NOC and Pollution Control NOC
• Device Master File (DMF) detailing design, specifications, and manufacturing processes. Learn how to prepare a DMF in our Device Master File Guide.
• Plant Master File (PMF) outlining the manufacturing site infrastructure and quality systems. See our Plant Master File Guide.
• Essential Principles Checklist demonstrating compliance with Indian medical device regulations
• Risk Management File documenting hazard analysis and mitigation strategies. For best practices, visit our Risk Management guide.
• Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, preferably ISO 13485:2016 certified

Import License Process (MD15) for Pancreatic Stents

For importers, the MD15 license is compulsory and administered by the Central Licensing Authority. The process is as follows:

1. Document Compilation: Assemble necessary certificates including existing manufacturing license, Free Sale Certificate, ISO 13485:2016, CE Marking Certificate, Device Master File, Plant Master File, and Wholesale License.

2. Application Submission (Form MD14): File your application on the CDSCO MD Online Portal.

3. Review and Queries: The CDSCO reviews the submission and raises queries which must be addressed promptly.

4. License Issuance: After satisfactory assessment, the MD15 import license is granted.

Explore the full import procedure in our Import License Guide.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate (FSC) issued by the regulatory authority of the exporting country
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale Drug License (for distribution within India)
• Company Constitution and Incorporation Proof

Timeline and Processing Duration

Note: The test license for MD9 adds approximately 1.5 to 2 months to the timeline.

Government Fees and Costs

Additional costs include testing fees at accredited laboratories and audit charges by notified bodies.

Common Challenges and Solutions

• Delayed Testing Reports: Engage with CDSCO-approved labs early and confirm testing timelines to avoid bottlenecks.

• Incomplete Documentation: Utilize detailed checklists and templates, such as those in our Device Master File and Plant Master File guides, to ensure completeness.

• Audit Non-Compliance: Conduct internal pre-audit assessments and training for staff to ensure readiness.

• Query Resolution Delays: Assign dedicated regulatory personnel to respond promptly and accurately to CDSCO observations.

Expert Consultation and Support

Given the complexity of Class C device licensing, partnering with experienced regulatory consultants can significantly reduce approval timelines and compliance risks. Our team has successfully guided over 500 manufacturers and importers through the CDSCO licensing maze, leveraging deep technical and regulatory expertise.

Getting Started with Your CDSCO License Application

1. Assess Your Product Classification: Confirm that your pancreatic stent falls under Class C using Medical Device Classification.

2. Plan for Testing: Contact CDSCO-approved testing labs early via the Testing Laboratories List.

3. Prepare Documentation: Begin compiling your Device Master File and Plant Master File using our comprehensive guides.

4. Apply for Test License (MD13): Initiate this prerequisite step through the CDSCO MD Online Portal.

5. Engage a Notified Body: For audit requirements related to MD9, consult the Notified Bodies List to select an accredited auditor.

6. Submit MD9 Application: After successful testing and documentation, file your manufacturing license application.

7. For Importers: Once manufacturing license is secured, compile import-specific documents and apply for MD15.

Embarking on the CDSCO licensing journey for pancreatic stents demands meticulous preparation and adherence to regulatory nuances. Leveraging our 25+ years of expertise can make your pathway smoother, faster, and compliant, ultimately bringing your critical medical device to the Indian market effectively.