CDSCO License for Ingestible event marker.

Comprehensive Guide to CDSCO Licensing for Ingestible Event Marker (Class C Medical Device)

Introduction: Understanding Your Ingestible Event Marker and Its Regulatory Importance

An ingestible event marker is a cutting-edge prescription medical device designed to record time-stamped, patient-logged events by communicating wirelessly through the body to an external recorder. This unique technology enables precise monitoring of medication adherence, enhancing patient care in clinical and hospital settings. Given its sophisticated function and patient safety implications, the device falls under Class C medical devices as per CDSCO regulations, requiring thorough regulatory compliance for manufacturing or importation in India.

Navigating the CDSCO licensing landscape efficiently is crucial to ensure your ingestible event marker reaches the Indian market without delays or compliance issues. Leveraging over 25 years of regulatory consulting experience and having successfully guided 500+ companies, we provide you with a detailed roadmap tailored specifically for this device.

CDSCO Regulatory Framework for Ingestible Event Markers (Class C Devices)

Per the Medical Device Rules, 2017, ingestible event markers are categorized under Class C due to their medium to high risk. The device is also listed under the category of General Hospital or Orthopaedic Instruments as per Notification 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022.

The Central Drugs Standard Control Organization (CDSCO) is the regulatory authority overseeing the approval, manufacturing, and import licensing of such devices, ensuring compliance with safety, quality, and efficacy standards.

Risk Classification and License Requirements for Your Device

Being a Class C device, the ingestible event marker requires a manufacturing license in the form of MD9 granted by the Central Licensing Authority, or an import license MD15 for imported devices. The MD9 license application process is more stringent compared to Class A or B devices and involves:

• Obtaining a Test License (Form MD13) first
• Product testing at government-approved laboratories
• Document preparation and submission
• Inspection and audit by CDSCO officials

For importers, the MD15 license process is streamlined but demands comprehensive documentation, including proof of manufacturing license from the country of origin.

Manufacturing License Process for Ingestible Event Marker (MD9 License)

1. Test License Application (Form MD13): Initiate the process by applying for a test license. This license authorizes you to manufacture the device for testing purposes only.
2. Product Testing: Conduct mandatory product testing at CDSCO-approved labs. You can find the list of Testing Laboratories authorized for this.
3. Document Preparation: Prepare and collate all required documents including Device Master File, Plant Master File, Risk Management File, and more.
4. License Application (Form MD7): Submit the manufacturing license application through the CDSCO MD Online Portal for the MD9 license.
5. Audit & Inspection: CDSCO officials will conduct an inspection of your manufacturing facility to verify compliance with quality management systems and regulatory requirements.
6. Queries & Resolution: Respond promptly to any queries raised during the audit or document review.
7. Grant of License: Upon successful completion, the MD9 manufacturing license is granted.

Manufacturing License Documents Required for MD9

• Company Constitution Documents
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualifications and Experience
• Fire Safety and Pollution Control NOCs
• Comprehensive Device Master File (DMF Guide)
• Plant Master File (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with Indian Medical Device Rules
• Risk Management File outlining hazard analysis and mitigation strategies (Risk Management)
• Product Test Reports from approved labs
• Labels and Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485:2016 certification)

Import License Process for Ingestible Event Marker (MD15 License)

For companies importing the ingestible event marker into India, the import license process includes:

1. Document Preparation: Compile documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE certificates, Device and Plant Master Files, wholesale license, and company constitution.
2. Application Submission: Apply using Form MD14 through the CDSCO MD Online Portal.
3. Departmental Review and Queries: Address any clarifications or additional information requests promptly.
4. Grant of License: Upon satisfactory review, MD15 import license is issued.

Import License Documents Required for MD15

• Valid Manufacturing License from the Country of Origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate or Equivalent
• Device Master File
• Plant Master File
• Wholesale License for distribution in India
• Company Constitution and Proof of Business Address

Timeline and Processing Duration

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

  • Test license (MD13): 1.5-2 months
  • Product testing: 1 month
  • Document preparation & submission: 2 weeks
  • Audit and inspection: 3-4 weeks
  • Query resolution and final approval: 2-3 weeks

• MD15 Import License: Approximately 5-6 months.

  • Document compilation and submission: 1 month
  • Departmental review and queries: 3-4 months
  • Final approval and license grant: 2-3 weeks

Government Fees and Costs for Licensing

Note: The fees are payable via the CDSCO MD Online Portal during application submission.

Common Challenges and Solutions

Challenge 1: Delays in Product Testing
Solution: Engage with CDSCO-approved laboratories early and schedule tests promptly. Confirm turnaround times and prioritize urgent testing.

Challenge 2: Incomplete Document Submission
Solution: Use detailed checklists and templates for Device Master Files and Plant Master Files to ensure completeness. Our expert guides help streamline this process.

Challenge 3: Audit Non-Compliance
Solution: Conduct internal audits and pre-inspections to ensure facility and QMS readiness before CDSCO inspections.

Challenge 4: Query Resolution Delays
Solution: Assign dedicated regulatory personnel to handle queries efficiently and prepare comprehensive responses.

Expert Consultation and Support

Navigating the regulatory landscape for Class C devices like ingestible event markers can be complex. Our seasoned regulatory consultants provide tailored support including:

• End-to-end application management on the CDSCO MD Online Portal
• Preparation of Device and Plant Master Files
• Coordination with notified bodies and testing labs
• Training on risk management and quality systems
• Audit readiness and mock inspections

Our proven track record with over 500 companies ensures you benefit from practical insights and avoid common pitfalls.

Getting Started with Your CDSCO License Application for Ingestible Event Marker

1. Classify your device accurately as Class C based on the latest CDSCO notifications.
2. Register your company and authorized signatory on the CDSCO MD Online Portal.
3. Initiate the Test License (MD13) application if manufacturing in India, or gather import documents for MD15.
4. Engage with an approved testing laboratory early to schedule product testing.
5. Prepare comprehensive documentation including Device Master File, Plant Master File, Risk Management, and QMS compliance.
6. Submit your application via the portal and monitor status regularly.
7. Prepare for audits and inspections by aligning your facility and documentation.

For detailed information and personalized assistance, explore our MD9 License Guide and Import License Guide.

Embarking on your regulatory journey with expert support ensures your ingestible event marker reaches patients safely and compliantly in India’s dynamic healthcare market.