CDSCO License for Electrosurgical cutting and coagulation  device and

Comprehensive Guide to CDSCO Licensing for Electrosurgical Cutting and Coagulation Devices (Class C)

As a trusted regulatory consultancy with over 25 years of experience assisting more than 500 medical device companies, we understand the complexities involved in navigating India’s CDSCO licensing landscape. This guide focuses specifically on the Electrosurgical Cutting and Coagulation Device and Accessories, classified as a Class C medical device under the Dermatological & Plastic Surgery category, with Notification No. 29/Misc./03/2020-DC (147), dated 26.07.2021.

Understanding the Device and Regulatory Importance

Electrosurgical cutting and coagulation devices utilize high-frequency electrical currents to precisely remove tissue and control bleeding during surgical procedures. Given their critical role in patient safety, the CDSCO mandates stringent regulatory control to ensure these devices meet quality, safety, and efficacy standards before being marketed or imported in India.

CDSCO Regulatory Framework for Electrosurgical Cutting and Coagulation Devices

These devices fall under Class C risk classification per the Indian Medical Device Rules, 2017. Class C devices are considered moderate-to-high risk and require a centralized licensing process managed by the CDSCO’s Central Licensing Authority. This involves compliance with specific testing, documentation, audits, and fees.

Risk Classification and License Requirements

• Risk Class: C (Moderate to High Risk)
• License Type:
  • Manufacturing License: MD9 (Application Form MD7)
  • Import License: MD15 (Application Form MD14)

The CDSCO classifies medical devices into four classes (A, B, C, D) based on risk. Class C devices like electrosurgical instruments require a more rigorous process than Class A/B but less than Class D.

Manufacturing License Process (MD9)

Obtaining an MD9 manufacturing license involves:

1. Test License Application (MD13): Apply for a test license to manufacture the device on a trial basis. This typically takes 1.5 to 2 months.
2. Product Testing: Conduct mandatory testing at CDSCO-approved government laboratories. Review the list of testing laboratories to find accredited facilities.
3. Documentation Preparation: Assemble comprehensive technical documentation, including Device Master File and Plant Master File.
4. Application Submission: Submit Form MD7 via the CDSCO MD Online Portal.
5. Inspection & Audit: CDSCO inspectors conduct audits of manufacturing facilities.
6. Query Resolution: Address any queries or deficiencies raised during audits.
7. License Grant: Upon successful evaluation, the MD9 license is granted.

The entire process typically spans 4 to 5 months.

Manufacturing License Documents Required

The following documents are critical for your MD9 license application:

• Company Constitution and Registration Proof
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualification and Experience Details
• Fire Safety Certificate (Fire NOC)
• Pollution Control Board Clearance (Pollution NOC)
• Device Master File (DMF) – Detailed design, manufacturing process, and quality data. Refer to our Device Master File Guide for comprehensive insights.
• Plant Master File (PMF) – Manufacturing site details. See our Plant Master File Guide.
• Essential Principles Checklist confirming compliance with safety and performance standards
• Risk Management File documenting hazard analysis and mitigation strategies. Learn more about medical device risk management.
• Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, preferably ISO 13485:2016 certification

Import License Process (MD15)

For companies importing Electrosurgical Cutting and Coagulation devices, an MD15 import license issued by the CDSCO Central Licensing Authority is mandatory. The steps include:

1. Documentation Preparation: Collect all required documents including manufacturing license from the country of origin.
2. Application Submission: Submit Form MD14 through the CDSCO MD Online Portal.
3. Evaluation: CDSCO reviews the documents and may raise queries.
4. Query Resolution: Promptly respond to any clarifications.
5. License Issuance: The MD15 import license is granted upon satisfactory compliance.

The import license process usually takes 5 to 6 months.

Import License Documents Required

Key documents required for MD15 license include:

• Valid Manufacturing License from Country of Origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate or equivalent regulatory approvals
• Device Master File and Plant Master File
• Wholesale License (if applicable)
• Company Constitution and Registration Proof

Timeline and Processing Duration

Government Fees and Costs

Additional costs include product testing fees at approved laboratories and audit charges.

Common Challenges and Solutions

• Delays in Testing: Government testing labs may have backlogs. Proactively schedule tests early and consider multiple approved labs.
• Documentation Gaps: Incomplete Device Master Files or Risk Management documentation can lead to query cycles. Use detailed checklists and expert review.
• Audit Readiness: Manufacturing facilities often fail audits due to non-compliance with QMS or safety norms. Conduct internal audits and training in advance.
• Query Resolution: Prompt and thorough responses to CDSCO queries can significantly shorten timelines.

Expert Consultation and Support

Navigating CDSCO’s regulatory processes requires specialized knowledge and experience. Our team has successfully guided over 500 companies through MD9 and MD15 licensing for Class C devices like electrosurgical instruments. We provide:

• End-to-end application management
• Customized Device and Plant Master File preparation
• Risk management strategy formulation
• Liaison with CDSCO authorities and notified bodies
• Audit preparation and mock inspections

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm Class C classification using resources such as our Medical Device Classification guide.
2. Prepare Essential Documentation: Start assembling your Device Master File, Plant Master File, and Risk Management File.
3. Schedule Product Testing: Contact CDSCO-approved labs early to book testing slots.
4. Register on CDSCO MD Online Portal: Submit initial applications and monitor status online.
5. Engage Expert Consultants: Consider partnering with experienced regulatory consultants to streamline the process and ensure compliance.

By following these practical steps and leveraging expert support, manufacturers and importers can successfully bring Electrosurgical Cutting and Coagulation devices to the Indian market efficiently and compliantly.

For detailed assistance, visit the CDSCO MD Online Portal to start your application or contact our regulatory experts today.