CDSCO License for Scintillation (gamma) camera

Comprehensive Guide to CDSCO Licensing for Scintillation (Gamma) Camera (Class A Medical Device)

As a trusted regulatory consulting firm with over 25 years of experience, we have successfully guided more than 500 medical device manufacturers and importers through the complex CDSCO licensing landscape. In this detailed guide, we focus on the Scintillation (gamma) camera — a Class A medical device under Interventional Radiology, intended to image radionuclide distribution in the body using photon radiation detection.

Understanding the Scintillation (Gamma) Camera and Its Regulatory Importance

A Scintillation (gamma) camera plays a critical role in nuclear medicine diagnostics by visualizing radionuclide distribution, enabling accurate disease detection and treatment monitoring. Given its application in patient care, adherence to regulatory standards set by the Central Drugs Standard Control Organization (CDSCO) is mandatory for manufacturing and marketing within India.

The device falls under risk Class A, denoting low risk but still necessitating compliance with the Medical Device Rules, 2017, including obtaining the appropriate manufacturing or import license.

CDSCO Regulatory Framework for Scintillation (Gamma) Camera

The regulatory framework for medical devices in India is governed by the Medical Device Rules (MDR) 2017 under the Drugs and Cosmetics Act. Since the Scintillation (gamma) camera is classified as Class A, the manufacturing license is issued by the State Licensing Authority under Form MD5 (MD3 Application).

Key regulatory references:

• Notification No. 29/Misc./03/2020-DC (146), dated 26.07.2021
• Device classification and licensing per Medical Device Classification

Risk Classification and License Requirements for Class A Devices

Class A devices like the Scintillation (gamma) camera are considered low risk but require:

• Test License (Form MD13) for product testing
• Manufacturing License (Form MD5) issued by State Licensing Authority

This process ensures compliance with essential principles, safety standards, and quality management systems.

Manufacturing License Process (MD5) for Scintillation (Gamma) Camera

The MD5 license process involves multiple stages:

1. Test License Application (Form MD13): Obtained first to conduct product testing.
2. Product Testing: Conducted at CDSCO-approved government laboratories.
3. Document Preparation: Comprehensive dossier including Device Master File (DMF), Plant Master File (PMF), Risk Management File, test reports, and Quality Management System (QMS) documents.
4. Application for Manufacturing License (Form MD3): Submit via the CDSCO MD Online Portal.
5. Audit by Notified Body: An approved notified body conducts an on-site audit of manufacturing facilities.
6. Query Resolution: Address queries from CDSCO and notified bodies promptly.
7. License Grant (Form MD5): Upon satisfactory audit and document review.

For notified bodies involved in MD5 audits, refer to the Notified Bodies List.

Manufacturing License Documents Required

For a Class A Scintillation (gamma) camera, prepare the following key documents:

• Company Constitution (e.g., Incorporation Certificate)
• Proof of Ownership/Rent Agreement of Manufacturing Premises
• Details of Qualified Technical Staff
• Fire NOC and Pollution Control NOC
• Device Master File (DMF) detailing design, specifications, and safety data (Device Master File Guide)
• Plant Master File (PMF) describing manufacturing processes and controls (Plant Master File Guide)
• Essential Principles Compliance Checklist
• Risk Management File outlining hazard analysis and mitigation (Risk Management)
• Test Reports from CDSCO-approved labs (Testing Laboratories)
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485:2016 compliant)

Import License Process (MD15) for Scintillation (Gamma) Camera

If you intend to import this device into India, the Import License (MD15) is mandatory and granted by the Central Licensing Authority.

Key steps include:

• Preparation of import-related documents
• Application submission via Form MD14 on the CDSCO MD Online Portal
• Query resolution with CDSCO
• License issuance (Form MD15)

Required documents for import license:

• Valid Manufacturing License from country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate or other applicable regulatory approvals
• Device Master File and Plant Master File
• Wholesale License
• Company Constitution

Timeline and Processing Duration

Manufacturing License (MD5) for Class A:

• Test License (MD13): 1.5 to 2 months
• Product Testing: 1 to 1.5 months
• Document Preparation & Application: 15 to 20 days
• Audit & Query Resolution: 1 to 1.5 months
• Total Duration: Approximately 3 to 4 months

Import License (MD15):

• Documentation & Application: 1 month
• Query Resolution: 2 to 3 months
• Total Duration: Approximately 5 to 6 months

Government Fees and Costs

For a Scintillation (gamma) camera under Class A:

• MD5 Manufacturing License:

  • Application Fee: Rs. 5,000
  • Fee per product: Rs. 500

• Test License (MD13):

  • Included within application fees, but lab testing costs vary (typically Rs. 1-2 lakhs depending on complexity)

• Import License (MD15):

  • Site Fee: USD 1,000
  • Fee per product: USD 50

Budgeting for notified body audit fees, lab testing charges, and document preparation support is essential for smooth licensing.

Common Challenges and Practical Solutions

Challenge: Delays in product testing due to limited availability of CDSCO-approved labs.

Solution: Early engagement with labs listed on the Testing Laboratories Directory and pre-planning sample submissions.

Challenge: Incomplete or inconsistent documentation leading to queries.

Solution: Utilize comprehensive checklists and templates, such as those provided in our Device Master File Guide, and conduct internal audits before submission.

Challenge: Scheduling audits with notified bodies can face bottlenecks.

Solution: Pre-arrange audit dates with notified bodies from the official Notified Bodies List to avoid last-minute delays.

Challenge: Understanding the nuanced requirements for risk management.

Solution: Implement a structured risk management process aligned with ISO 14971; our detailed Risk Management resource can guide you.

Expert Consultation and Support

With over 25 years of specialized expertise, we provide end-to-end consultancy services including:

• Regulatory strategy and classification
• Document preparation and review
• Coordination with notified bodies and testing labs
• Application filing and follow-up
• Training on compliance and quality systems

Our hands-on approach ensures timely approvals and regulatory compliance for your Scintillation (gamma) camera.

Getting Started with Your CDSCO License Application

1. Assess your device classification: Confirm your device is Class A under current CDSCO guidelines.
2. Gather your technical and quality documentation: Prepare your DMF, PMF, and risk files.
3. Apply for the Test License (Form MD13): Initiate product testing early via the CDSCO MD Online Portal.
4. Engage with a notified body: Identify and schedule your audit using the Notified Bodies List.
5. Submit your Manufacturing License Application (Form MD3): Complete and upload your dossier through the CDSCO MD Online Portal.
6. Prepare for audit and queries: Be responsive and thorough in addressing CDSCO and notified body feedback.

By following these practical steps and leveraging our expertise, you can confidently navigate the CDSCO licensing pathway for your Scintillation (gamma) camera and successfully launch in the Indian market.

For personalized support and tailored consulting, contact us to leverage our proven track record in medical device regulatory approvals.