CDSCO License for General electrosurgical unit
Medical Device Information
Intended Use
A device accompanied by accessories that cuts/coagulates tissues with a high-frequency current or with the electricity/heat of the heating element. The device is used by a physician to confirm that an incision or coagulation is made as intended, macroscopically or microscopically.
Introduction to General Electrosurgical Units and Regulatory Importance
General Electrosurgical Units (GEUs) play a critical role in dermatological and plastic surgery procedures by enabling precise cutting and coagulation of tissues using high-frequency electrical currents or heating elements. Given their invasive nature and potential risks like electrical hazards and tissue damage, these devices are subject to stringent regulatory controls in India. Compliance with CDSCO (Central Drugs Standard Control Organization) regulations ensures safety, efficacy, and market access for manufacturers and importers.
With over 25 years of expertise, we have guided more than 500 companies through the complex CDSCO licensing processes, particularly for Class C devices like the GEU. This comprehensive guide is designed to help you navigate the regulatory landscape efficiently and compliantly.
CDSCO Regulatory Framework for General Electrosurgical Units
The CDSCO regulates medical devices under the Medical Device Rules (MDR) 2017. Electrosurgical units fall under the dermatological and plastic surgery category, notified under 29/Misc./03/2020-DC (147) dated 26.7.2021. As per the CDSCO classification, your GEU is a Class C device due to its moderate to high risk, requiring central licensing authority approval.
Understanding this framework helps in aligning your product development, testing, and documentation to comply fully with Indian regulations.
Risk Classification and License Requirements for Class C Devices
Class C devices, including General Electrosurgical Units, require an MD9 manufacturing license issued by the Central Licensing Authority. The process ensures that the device meets stringent safety and performance standards.
- Device Risk Class: Class C
- License Type: MD9
- Regulatory Authority: CDSCO Central Licensing Authority
- Application Form: MD7
Manufacturers must complete a test license (MD13) phase before applying for the MD9 license, which involves product testing and audit compliance.
For detailed classification criteria, refer to our Medical Device Classification guide.
Manufacturing License Process (MD9) for General Electrosurgical Units
The MD9 license process for Class C devices is comprehensive, typically spanning 4 to 5 months. It consists of the following phases:
Application for Test License (MD13): Initiate with a test license application to conduct product testing in approved laboratories. The test license takes approximately 1.5 to 2 months to be granted.
Product Testing: Submit samples of your GEU to government-approved testing laboratories. Testing evaluates compliance with Indian standards and safety requirements. You can find authorized labs on the CDSCO Testing Laboratories list.
Document Preparation: Compile technical documentation, including the Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documents.
Submission of Manufacturing License Application (Form MD7): Apply online via the CDSCO MD Online Portal.
Audit by CDSCO Inspectors: The CDSCO conducts a detailed audit of your manufacturing site and quality systems.
Query Resolution: Address any queries from CDSCO or auditors promptly to avoid delays.
Grant of MD9 License: Upon successful audit and document verification, CDSCO issues the MD9 manufacturing license.
We recommend early engagement with notified bodies and auditors to streamline the audit phase. See the Notified Bodies List for audit partners.
Manufacturing License Documents Required for MD9
For your General Electrosurgical Unit, the following documents are essential:
- Company Constitution Documents: Incorporation certificate, PAN, GST registration
- Proof of Ownership or Lease of Manufacturing Premises
- Technical Staff Qualifications: Details of responsible technical personnel
- Fire and Pollution NOCs: Certificates from relevant authorities
- Device Master File (DMF): Detailed technical specifications and design data (See our DMF Guide)
- Plant Master File (PMF): Manufacturing processes, equipment, and environment (PMF Guide)
- Essential Principles Compliance Checklist: Demonstrating conformity with MDR requirements
- Risk Management File: Per ISO 14971 standards, addressing risks related to electrical safety and tissue interaction (Risk Management Guide)
- Test Reports: From government-approved labs confirming device performance and safety
- Labels and Instructions for Use (IFU): As per CDSCO guidelines
- Quality Management System Documents: ISO 13485 certification, SOPs, CAPA, etc.
Ensuring thorough and accurate documentation is vital. Incomplete dossiers are a leading cause of delays.
Import License Process (MD15) for General Electrosurgical Units
If you intend to import General Electrosurgical Units into India, you must obtain an MD15 import license from the CDSCO Central Licensing Authority.
Key points for the import license:
- Application Form: MD14
- Process Duration: Approximately 5 to 6 months
- No Test License Required: Unlike manufacturing, importing does not require an MD13 test license
The process involves document submission, query resolution, and license grant. Submit your application through the CDSCO MD Online Portal.
Import License Documents Required for MD15
Documents required for importing General Electrosurgical Units include:
- Valid Manufacturing License (MD9 or equivalent) from the country of origin
- Free Sale Certificate from the exporting country
- ISO 13485:2016 certification
- CE Certificate or other international certifications
- Device Master File and Plant Master File
- Wholesale Drug License
- Company Constitution Documents
Fees vary based on device class and site, typically higher for Class C devices. We recommend reviewing the detailed Import License Guide for specifics.
Timeline and Processing Duration for MD9 Licensing
| Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 1 – 1.5 months |
| Document Preparation | 1 month (concurrent) |
| Submission and Audit | 1 – 1.5 months |
| Query Resolution and Grant | 0.5 month |
Total Time: Approximately 4 to 5 months
Early preparation and proactive query handling can reduce delays significantly.
Government Fees and Costs for MD9 License
- Application Fee: Rs 50,000 per application
- Product Fee: Rs 1,000 per product
Additional costs may include testing fees at government-approved labs and audit fees charged by notified bodies.
Investing in expert regulatory consulting can optimize these costs by avoiding re-submissions and non-compliance penalties.
Common Challenges and Solutions
Incomplete Documentation: Many applicants overlook detailed technical files or risk management documents. Solution: Use detailed checklists and professional consultants.
Delayed Testing Reports: Government labs can have backlog issues. Solution: Plan sample submission early and consider pre-testing in accredited private labs.
Audit Non-Compliance: Lack of QMS or unsafe manufacturing conditions cause rejection. Solution: Conduct internal audits before CDSCO inspections.
Query Resolution Delays: Slow responses extend timelines. Solution: Assign a dedicated regulatory liaison to manage communications.
Expert Consultation and Support
Navigating CDSCO regulations for Class C devices like General Electrosurgical Units requires expertise and experience. Our consultancy has successfully helped over 500 medical device companies secure timely approvals.
We provide:
- End-to-end license application support
- Document preparation and gap analysis
- Coordination with notified bodies and testing labs
- Training on regulatory compliance and audit readiness
Partnering with experts can save months of processing time and ensure your device reaches the Indian market smoothly.
Getting Started with Your CDSCO License Application
Assess Device Classification: Confirm your GEU as Class C using official CDSCO guidelines.
Prepare Documentation: Start compiling your Device and Plant Master Files, Risk Management, and QMS documents.
Apply for Test License (MD13): Submit through the CDSCO MD Online Portal.
Schedule Product Testing: Coordinate with government-approved testing labs.
Engage a Notified Body for Audit: Select from the Notified Bodies List and schedule your audit.
Submit MD9 License Application: After successful testing and audit, apply online with complete documents.
Monitor and Respond to Queries: Assign responsible personnel for timely communication.
Starting early and following these steps systematically will streamline your path to successful CDSCO licensing for your General Electrosurgical Unit.
For tailored assistance and further clarifications, feel free to contact our regulatory experts who specialize in CDSCO compliance for Class C medical devices.
