CDSCO License for Gastrointestinal endoscopic clip, long-term

Comprehensive CDSCO Licensing Guide for Gastrointestinal Endoscopic Clip, Long-Term (Class C Medical Device)

Navigating the complex regulatory landscape for medical devices in India can be daunting, especially for sophisticated devices like the gastrointestinal (GI) endoscopic clip designed for long-term implantation. With over 25 years of experience aiding 500+ manufacturers and importers, we provide you with an expert, step-by-step guide to secure your CDSCO license efficiently and compliantly.

Introduction: Understanding the Gastrointestinal Endoscopic Clip and Its Regulatory Importance

The gastrointestinal endoscopic clip (long-term) is a sterile Class C medical device intended for implantation within the GI tract for periods exceeding 30 days. It serves critical functions such as endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, and treatment of mucosal or submucosal defects. Given its invasive nature and long-term implantation, regulatory oversight is stringent to ensure patient safety and device efficacy.

Securing the appropriate license from the Central Drugs Standard Control Organization (CDSCO) is mandatory to manufacture or import this device in India. This process involves rigorous documentation, testing, and audits aligned with India’s Medical Device Rules (MDR) 2017.

CDSCO Regulatory Framework for Gastrointestinal Endoscopic Clips

As per the CDSCO’s notified list (Notification 29/Misc./03/2020-DC (182), dated 27.09.2021), the gastrointestinal endoscopic clip falls under Class C devices due to its medium to high risk profile. This classification necessitates obtaining an MD9 manufacturing license or an MD15 import license, both regulated by the Central Licensing Authority (CLA).

Risk Classification and License Requirements for Class C Devices

• Risk Class: C (medium-to-high risk)
• License Type for Manufacturers: MD9 (Application Form MD7)
• License Type for Importers: MD15 (Application Form MD14)
• Regulatory Authority: Central Licensing Authority (CLA)

Class C devices require comprehensive evaluation including product testing, technical documentation review, and an on-site audit by CDSCO inspectors.

Manufacturing License Process for MD9 (Class C Device)

1. Test License (MD13): Before applying for the MD9 license, manufacturers must obtain a test license under Form MD13. This preliminary step allows product sampling and testing.
2. Product Testing: Testing must be conducted at CDSCO-approved laboratories to verify compliance with applicable standards. You can refer to the list of testing laboratories for authorized centers.
3. Document Preparation: Compile all technical and quality documents including Device Master File (DMF), Plant Master File (PMF), risk management files, and Essential Principles Checklist.
4. Application Submission: Submit the MD9 license application on the CDSCO MD Online Portal using Form MD7.
5. Audit: Once documentation is reviewed, CDSCO inspectors conduct an on-site audit of manufacturing facilities and quality systems.
6. Queries and Resolution: Address any queries or deficiencies raised during audit or document review promptly.
7. Grant of License: Upon satisfactory compliance, CDSCO issues the MD9 license allowing commercial manufacture.

Manufacturing License Documents Required for MD9

• Company Constitution (e.g., incorporation certificate)
• Proof of ownership or lease of manufacturing premises
• Technical staff qualifications and experience details
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (refer to our detailed Device Master File guide)
• Plant Master File (PMF guide)
• Essential Principles Checklist
• Risk Management File (aligned with ISO 14971; see our Risk Management guide)
• Product Test Reports from CDSCO-approved labs
• Product labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, typically ISO 13485:2016 certification

Import License Process for MD15 (Class C Device)

For importers, the process involves:

1. Document Preparation: Gather necessary manufacturing license, Free Sale Certificate, ISO 13485:2016, CE certificate, DMF, PMF, wholesale license, and company constitution.
2. Application Submission: Apply for MD15 license on the CDSCO MD Online Portal using Form MD14.
3. Queries Resolution: Respond to CDSCO's queries in a timely manner.
4. Grant of License: CDSCO issues MD15 import license allowing the import and sale of the device in India.

Import License Documents Required for MD15

• Valid Manufacturing License (MD9 or equivalent) from country of origin
• Free Sale Certificate (FSC)
• ISO 13485:2016 Certification
• CE Certificate or other international certification
• Device Master File and Plant Master File
• Wholesale License
• Company Constitution Documents

Timeline and Processing Duration

• MD9 Manufacturing License: Approximately 4-5 months total.

  • Test License (MD13): 1.5–2 months
  • Product Testing: 3-4 weeks
  • Document Submission & Review: 3-4 weeks
  • Audit & License Grant: 4-6 weeks

• MD15 Import License: Approximately 5-6 months.

Timelines are influenced by the completeness of documentation and responsiveness to queries. Proactive preparation can significantly reduce delays.

Government Fees and Costs

• MD9 License:

  • Application Fee: INR 50,000
  • Per Product Fee: INR 1,000

• MD15 Import License:

  • Class C Devices: INR 3,000 per site
  • Per Product Fee: INR 1,500

Additional costs include testing fees at government-approved labs and costs associated with audits, technical documentation preparation, and potential consultancy support.

Common Challenges and Solutions

• Incomplete Documentation: Ensure all files such as DMF, PMF, Risk Management, and Essential Principles Checklist are meticulously prepared. Utilize our expert guidance to create compliant files.
• Delays in Product Testing: Coordinate early with CDSCO-approved laboratories to schedule timely testing.
• Audit Non-Compliance: Conduct internal audits before the CDSCO inspection to identify gaps.
• Query Resolution Delays: Assign a dedicated regulatory liaison to respond promptly to CDSCO queries.

Expert Consultation and Support

With a proven track record of assisting over 500 companies, we offer tailored regulatory consulting services to streamline your MD9 or MD15 license application. From document preparation, mock audits, to regulatory strategy, our expertise ensures your success.

Getting Started with Your CDSCO License Application

1. Classify Your Device Correctly: Confirm your device is Class C by reviewing the medical device classification.
2. Initiate Test License (MD13): Apply promptly to avoid downstream delays.
3. Engage Testing Laboratories Early: Book slots at CDSCO-approved labs from the official list.
4. Prepare Complete Documentation: Leverage our Device Master File and Plant Master File guides for thorough preparation.
5. Submit Applications on CDSCO MD Online Portal: Use the official portal for all license applications.
6. Plan for Audit: Conduct readiness assessments and ensure QMS compliance.

By following these practical steps and working with experienced regulatory consultants, manufacturers and importers of the gastrointestinal endoscopic clip can confidently navigate the CDSCO licensing process and bring their life-saving device to the Indian market.

For personalized support and a detailed roadmap tailored to your device, contact our expert regulatory team today.