CDSCO License for Electrosurgical device for over- the- counter aesthetic use

Comprehensive Guide to CDSCO Licensing for Electrosurgical Devices for Over-the-Counter Aesthetic Use (Class B)

As seasoned regulatory consultants with over 25 years of experience and having assisted more than 500 companies in securing CDSCO licenses, we understand the intricacies involved in bringing advanced medical devices like electrosurgical devices for over-the-counter aesthetic use to the Indian market. This device, classified as Class B under CDSCO regulations, utilizes radiofrequency energy to induce localized heating for non-invasive aesthetic treatments, primarily in dermatological and plastic surgery applications. Given its specific risk profile and intended use, obtaining the right regulatory approvals is critical to ensure compliance, safety, and market access.

CDSCO Regulatory Framework for Electrosurgical Devices (Class B)

The Central Drugs Standard Control Organization (CDSCO) governs the import and manufacture of medical devices in India under the Medical Device Rules, 2017. Electrosurgical devices used for aesthetic purposes fall under the dermatological & plastic surgery category and are regulated as Class B devices, indicating low to moderate risk.

This classification mandates a stringent yet streamlined approval process, primarily overseen by State Licensing Authorities if manufactured locally, or the Central Licensing Authority for imports.

The relevant notification for this device type is 29/Misc./03/2020-DC (147), dated 26.07.2021, which sets forth the regulatory requirements and classifications.

Risk Classification and License Requirements

• Device Type: Electrosurgical device for over-the-counter aesthetic use
• Risk Class: B (Low to moderate risk)
• Regulatory License: MD5 Manufacturing License (Form MD3) for local manufacturing
• Authority: State Licensing Authority

For Class B devices, the MD5 license is mandatory for manufacturing. This involves a multi-step approval process including test licensing, product testing, and audit inspections.

Manufacturing License Process (MD5)

The MD5 licensing journey typically unfolds over 3 to 4 months and involves the following stages:

1. Test License Application (Form MD13): Initiate the application for a test license to legally manufacture the device in limited quantities for testing.
2. Product Testing: Submit device samples to CDSCO-approved government labs for essential safety and performance testing. Refer to the Testing Laboratories list for approved facilities.
3. Documentation Preparation: Compile comprehensive technical files including Device Master File, Plant Master File, Risk Management File, QMS documentation, and Essential Principles Checklist.
4. MD5 License Application (Form MD3): Submit the manufacturing license application through the CDSCO MD Online Portal.
5. Notified Body Audit: Undergo a mandatory audit by a notified body to verify compliance. Check the List of Notified Bodies to select an authorized auditor.
6. Query Resolution: Address any observations or queries raised by the licensing authority or notified body.
7. License Grant: Upon successful audit and document approval, the MD5 manufacturing license will be granted.

Manufacturing License Documents Required

Manufacturers must prepare and submit the following critical documents:

• Company Constitution and Incorporation Certificate
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire NOC and Pollution Control NOC
• Device Master File (DMF): Detailed device specifications, design, and manufacturing process (Device Master File Guide)
• Plant Master File (PMF): Facility layout, equipment details, and quality management system (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with applicable standards
• Risk Management File documenting hazard analysis and mitigation (Risk Management)
• Test Reports from CDSCO-approved laboratories
• Labels and Instructions for Use (IFU) in compliance with Indian regulations
• Quality Management System Documents (ISO 13485 certification preferred)

Import License Process (MD15)

If you are an importer aiming to bring this electrosurgical device into India, the MD15 import license from the Central Licensing Authority is required.

Key steps include:

1. Document Compilation: Prepare documents such as manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, Device and Plant Master Files, and wholesale license.
2. License Application (Form MD14): Submit your application on the CDSCO MD Online Portal.
3. Query Response: Address any clarifications requested by CDSCO.
4. License Issuance: Upon satisfaction, the import license (MD15) is granted.

Note: Unlike manufacturing licenses, no test license is required for imports.

Import License Documents Required

• Valid Manufacturing License from Country of Origin
• Free Sale Certificate
• ISO 13485:2016 Quality Management System Certificate
• CE Marking Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale License (if applicable)
• Company Constitution Documents

Timeline and Processing Duration

Manufacturers should anticipate approximately 4 months from test license application to final manufacturing license issuance.

Government Fees and Costs

For a Class B electrosurgical device, the fee structure is as follows:

• MD5 License

  • Application Fee: Rs. 5,000
  • Per Product Fee: Rs. 500

• MD15 Import License

  • Site Fee: $2,000 (approx. Rs. 1.6 lakh)
  • Per Product Fee: $1,000 (approx. Rs. 80,000)

Additional costs include notified body audit fees and testing laboratory charges, which vary by provider.

Common Challenges and Solutions

• Incomplete Documentation: Many applicants face delays due to missing technical files or inadequate risk management documentation. Solution: Use detailed checklists and templates, such as those in our Device Master File guide.

• Delayed Product Testing: Government labs often have backlogs. Solution: Plan early and consider alternative approved labs from the Testing Laboratories list.

• Audit Non-Compliance: Facilities may fail notified body audits due to poor QMS implementation. Solution: Conduct pre-audit internal assessments and train staff thoroughly.

• Regulatory Query Backlogs: Replies to CDSCO queries can take time if not well-prepared. Solution: Engage regulatory experts to draft precise, complete responses promptly.

Expert Consultation and Support

Navigating CDSCO regulations requires meticulous attention to detail and procedural knowledge. Our team has successfully guided over 500 companies through the MD5 and MD15 licensing pathways, ensuring optimized timelines and compliance.

We offer:

• Pre-submission gap analysis
• Document preparation assistance
• Coordination with notified bodies and testing labs
• Query management and audit support

Getting Started with Your CDSCO License Application

1. Identify Device Classification: Confirm your device is Class B under the Medical Device Rules. Use tools like the Medical Device Classification guide.
2. Initiate Test License Application: File Form MD13 via the CDSCO MD Online Portal.
3. Prepare Technical Documentation: Assemble your Device Master File, Plant Master File, and Risk Management File.
4. Schedule Product Testing: Engage an approved testing laboratory early to avoid bottlenecks.
5. Plan for Audit: Select a notified body from the Notified Bodies list and schedule your facility audit.
6. Submit Manufacturing License Application: Once test license and testing are completed, apply for the MD5 license online.
7. Respond Expediently to Queries: Maintain open communication with CDSCO and auditors for timely query resolution.

Embarking on this regulatory journey with expert support can dramatically improve your chances of timely license approval, enabling you to bring your electrosurgical device to the Indian aesthetic market confidently and compliantly.