CDSCO License for Robotic Guidance system for image Guided procedures

Comprehensive Guide to CDSCO Licensing for Robotic Guidance Systems for Image-Guided Procedures

The Robotic Guidance System designed as an accessory to imaging systems (CT, CT-PET) plays a pivotal role in oncology by enabling precise spatial positioning and orientation of instrument guides during percutaneous image-guided interventional procedures. Notably, this device does not make direct contact with patients but assists surgeons in advancing instruments manually, enhancing procedural accuracy and safety.

Given its critical function and classification as a Class B medical device under the Central Drugs Standard Control Organization (CDSCO) regulatory framework, securing the appropriate manufacturing or import license is mandatory for legal market entry in India. With over 25 years of expertise and having supported more than 500 companies, we provide you with an in-depth, actionable roadmap tailored specifically for this complex device.

CDSCO Regulatory Framework for Robotic Guidance Systems

The CDSCO regulates medical devices under the Medical Device Rules, 2017 (MDR 2017). Devices like the Robotic Guidance System fall under Class B, which denotes low to moderate risk. Compliance involves obtaining a manufacturing license (MD5) or import license (MD15) depending on your business model.

The regulatory notification for this device (File No. 29/Misc./03/2020-DC (153) — Part 1, dated 11.10.2022) confirms its classification and intended use, streamlining the application process.

To begin, manufacturers must register on the CDSCO MD Online Portal to submit their applications and track progress efficiently.

Risk Classification and License Requirements

• Device Risk Class: B (Low-Moderate Risk)
• Applicable License: MD5 (Manufacturing License) granted by the State Licensing Authority

This classification dictates the procedural steps, documentation, and fees involved. For Class B devices, test licenses and audits by notified bodies are mandatory before final license issuance.

Manufacturing License Process (MD5) for Class B Devices

The MD5 licensing process entails several key stages:

1. Test License (Form MD13): Before manufacturing, apply for a test license allowing product testing. This process takes approximately 1.5 to 2 months.

2. Product Testing: Conduct product testing through CDSCO-approved laboratories listed on the Testing Laboratories page. Testing covers safety, performance, and compliance with Essential Principles.

3. Document Preparation: Assemble comprehensive documentation, including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) records.

4. Application Submission (Form MD3): Submit the manufacturing license application with all supporting documents via the CDSCO MD Online Portal.

5. Audit by Notified Body: A notified body from the official Notified Bodies List will conduct a factory audit focusing on compliance with MDR 2017.

6. Query Resolution: Address any observations or queries raised during audit or application review promptly.

7. License Grant (Form MD5): Upon successful completion, the State Licensing Authority grants the manufacturing license.

Typically, the entire process spans 3 to 4 months, assuming timely responses and complete documentation.

Manufacturing License Documents Required

For your Robotic Guidance System, ensure the following documents are meticulously prepared:

• Company Constitution (Incorporation Certificate, MOA, AOA)
• Proof of Ownership or Lease of Manufacturing Premises
• Credentials of Technical Staff (Qualifications and Experience)
• Fire NOC and Pollution Control Board Certificate
• Device Master File (DMF): Detailed design, components, specifications, and manufacturing process. Our detailed Device Master File Guide can assist you.
• Plant Master File (PMF): Description of manufacturing facility, equipment, and quality controls. Refer to our Plant Master File Guide for best practices.
• Essential Principles Compliance Checklist
• Risk Management File per ISO 14971 standards (Risk Management insights)
• Test Reports from approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System documentation (ISO 13485:2016 compliant)

Import License Process (MD15) for Robotic Guidance Systems

If importing the Robotic Guidance System into India, an MD15 license from the Central Licensing Authority is required.

The MD15 process is as follows:

1. Document Preparation: Compile manufacturing license from the country of origin, Free Sale Certificate, ISO 13485 certification, CE Certificate (if applicable), Device and Plant Master Files, and wholesale license.

2. Application Submission (Form MD14): Apply online on the CDSCO MD Online Portal.

3. Query Resolution: Respond to any queries raised by CDSCO officials.

4. License Issuance (Form MD15): Upon satisfaction, the import license is granted.

Expect a processing duration of around 5 to 6 months.

Import License Documents Required

Key documents include:

• Manufacturing License from country of origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate
• Device Master File
• Plant Master File
• Wholesale License in India
• Company Constitution Documents

Timeline and Processing Duration

Proactive communication with authorities and thorough documentation can reduce delays significantly.

Government Fees and Costs

• MD5 License: Rs 5,000 per application + Rs 500 per product
• MD15 Import License:
  • Class B: Rs 2,000 per site + Rs 1,000 per product

Additional costs to budget for include:

• Testing fees at government-approved labs
• Notified body audit charges
• Technical consultancy and document preparation

Common Challenges and Solutions

Challenge: Delays in test report acquisition

• Solution: Initiate test license application early and select testing labs with proven turnaround times.

Challenge: Incomplete or inconsistent documentation

• Solution: Use structured checklists and templates such as the Device and Plant Master File guides linked above.

Challenge: Audit non-conformities

• Solution: Conduct pre-audit internal assessments and train staff thoroughly.

Challenge: Query resolution delays

• Solution: Assign dedicated regulatory personnel to manage and respond promptly.

Expert Consultation and Support

Navigating CDSCO licensing for a sophisticated device like the Robotic Guidance System requires expert guidance. With our extensive experience supporting over 500 medical device companies, we provide:

• End-to-end application management
• Document preparation and review
• Coordination with notified bodies and testing labs
• Audit preparedness and mock audits
• Timely query resolution

Our consultancy ensures your device meets all regulatory expectations, accelerating your time to market.

Getting Started with Your CDSCO License Application

1. Register on the CDSCO MD Online Portal.
2. Assess your device classification and confirm the required license type (MD5 for manufacturing).
3. Begin preparing the Test License (Form MD13) for product testing.
4. Engage with notified bodies early by reviewing the Notified Bodies List.
5. Compile all essential documents meticulously; leverage our guides on Device and Plant Master Files.
6. Plan your internal audit and quality management upgrades to align with ISO 13485:2016.
7. Submit applications and maintain open communication with CDSCO authorities for query resolution.

Starting early and maintaining a proactive approach is key to a successful, timely approval process. Our team is ready to assist you at every step to ensure your Robotic Guidance System achieves compliant market access in India.

For tailored support and actionable insights, connect with our regulatory experts today.