CDSCO License for Gastro-oesophageal antireflux prosthesis

Comprehensive Guide to CDSCO Licensing for Gastro-oesophageal Antireflux Prosthesis

Gastro-oesophageal antireflux prosthesis is a critical implantable device designed to reduce sliding hiatal hernia and prevent gastric reflux into the oesophagus. Classified as a Class C medical device under CDSCO regulations, it falls within the gastroenterology category and requires rigorous compliance with Indian regulatory standards before market entry. Understanding the regulatory framework and license application process is essential for manufacturers and importers aiming to introduce this lifesaving device in India.

CDSCO Regulatory Framework for Gastro-oesophageal Antireflux Prosthesis

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India, ensuring safety, efficacy, and quality. The gastro-oesophageal antireflux prosthesis is notified under the Gazette Notification 29/Misc./03/2020-DC (182) dated 27.09.2021, categorizing it as a Class C device due to its implantable nature and associated risk profile.

Class C devices require approval from the Central Licensing Authority, involving a comprehensive evaluation process including product testing, documentation audit, and on-site inspections.

Risk Classification and License Requirements

• Device Name: Gastro-oesophageal antireflux prosthesis
• Risk Class: C (Moderate to High Risk)
• Regulatory Pathway: MD9 Manufacturing License (Form MD7) for manufacturing
• Import License: MD15 License (Form MD14)

Being a Class C device, the manufacturing license must be obtained from the central CDSCO authority with a detailed submission of technical and quality documents.

Manufacturing License Process (MD9)

The MD9 license process for Class C devices typically takes 4-5 months and involves the following sequential steps:

1. Test License Application (Form MD13): Obtain a test license allowing you to manufacture the device for testing purposes. This stage takes approximately 1.5-2 months.
2. Product Testing: Conduct mandatory testing in CDSCO-recognized laboratories to validate safety and performance. Refer to the Testing Laboratories list for approved labs.
3. Document Preparation: Compile all required technical files including Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documents.
4. License Application Submission (Form MD7): Submit the MD9 application through the CDSCO MD Online Portal with all supporting documents.
5. Audit and Inspection: CDSCO officials conduct a detailed audit of manufacturing facilities and QMS compliance.
6. Query Resolution: Address any queries raised during the audit or document review promptly.
7. License Grant: Upon satisfactory compliance, the MD9 license is issued on Form MD9.

Manufacturing License Documents Required

For your gastro-oesophageal antireflux prosthesis manufacturing license, ensure the following documentation is prepared meticulously:

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Technical Staff Qualification and Experience Certificates
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF)
• Plant Master File (PMF)
• Essential Principles Checklist specific to implantable gastroenterology devices
• Risk Management File detailing hazard analysis and mitigation strategies (Risk Management Guidance)
• Test Reports from approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documentation compliant with ISO 13485:2016

Import License Process (MD15)

For importers intending to bring the gastro-oesophageal antireflux prosthesis into India, the import license MD15 is mandatory and is granted by the Central Licensing Authority. The process, which takes approximately 5-6 months, includes:

1. Document Compilation: Collect necessary certificates including manufacturing license, Free Sale Certificate, ISO 13485:2016, CE Certificate, DMF, PMF, and wholesale license.
2. License Application (Form MD14): Submit the application through the CDSCO MD Online Portal.
3. Review and Queries: Respond promptly to any queries raised by CDSCO.
4. License Approval: Receive the MD15 import license allowing lawful import and sale.

Import License Documents Required

• Valid Manufacturing License of the product from the country of origin
• Free Sale Certificate issued by the regulatory authority of the exporting country
• ISO 13485:2016 Certification
• CE Certificate or equivalent international certification
• Device Master File and Plant Master File
• Wholesale Drug License for the importer
• Company Constitution Documents

Timeline and Processing Duration

Overall, manufacturing license (MD9) takes about 4-5 months, while import license (MD15) takes 5-6 months.

Government Fees and Costs

• MD9 Manufacturing License:

  • Application Fee: Rs. 50,000
  • Per Product Fee: Rs. 1,000

• MD15 Import License:

  • Site Fee: Rs. 3,000 per site
  • Per Product Fee: Rs. 1,500

Additional costs include testing fees at government-approved laboratories and expenses related to document preparation and audit readiness.

Common Challenges and Solutions

• Challenge: Delays in obtaining test reports due to backlog at testing labs.

  • Solution: Initiate testing early and engage with multiple approved labs listed on the CDSCO Testing Laboratories page.

• Challenge: Incomplete Device Master File or Risk Management File leading to query rejections.

  • Solution: Follow detailed templates and expert guidance such as our Device Master File Guide and Risk Management implementation tips.

• Challenge: Non-compliance during audit/inspection.

  • Solution: Conduct internal mock audits and ensure all QMS elements align with ISO 13485 and CDSCO requirements.

• Challenge: Confusion navigating CDSCO online portals.

  • Solution: Use the official CDSCO MD Online Portal and consider expert consultancy for application submission.

Expert Consultation and Support

With over 25 years of experience and more than 500 successful CDSCO license approvals for medical devices, we specialize in guiding manufacturers and importers through the complex regulatory landscape. Our expert team offers:

• Comprehensive gap analysis of your technical documentation
• Assistance in preparing Device and Plant Master Files
• Coordination with notified bodies and testing laboratories
• End-to-end application submission and query resolution support
• Training on regulatory compliance and audit readiness

Getting Started with Your CDSCO License Application

1. Assess your device classification: Confirm your gastro-oesophageal antireflux prosthesis is Class C as per the Medical Device Classification guidelines.
2. Initiate test license application: Apply for MD13 test license immediately via the CDSCO MD Online Portal.
3. Plan testing timelines: Coordinate with CDSCO-approved testing labs early to avoid delays.
4. Prepare documentation: Leverage our detailed guides to compile comprehensive Device Master File, Plant Master File, Risk Management File, and QMS documentation.
5. Schedule pre-audit reviews: Engage experts to review your documentation and site readiness before official audits.
6. Submit application and track progress: Use the online portal for submission and stay responsive to departmental queries.

By following these detailed steps and leveraging expert support, manufacturers and importers of gastro-oesophageal antireflux prostheses can navigate the CDSCO licensing process efficiently and secure timely approvals to access the Indian market.

For personalized assistance, feel free to contact our regulatory consulting team to discuss your specific project requirements and roadmap.