CDSCO License for Anaesthetic gas scavenging terminal unit

Comprehensive Guide to CDSCO Licensing for Anaesthetic Gas Scavenging Terminal Unit (Class A Medical Device)

As a specialized medical device in the anesthesiology category, the Anaesthetic Gas Scavenging Terminal Unit plays a crucial role in ensuring safe operation by providing an outlet assembly for connecting or disconnecting an Anaesthetic Gas Scavenging System (AGSS). Classified as a Class A device under CDSCO regulations, it is considered low risk but still requires strict adherence to regulatory compliance for manufacturing and import within India.

With over 25 years of experience assisting 500+ companies in navigating the complex CDSCO licensing landscape, we provide you with practical, detailed guidance to streamline your application process, avoid common pitfalls, and achieve timely approval.

CDSCO Regulatory Framework for Anaesthetic Gas Scavenging Terminal Unit

The Central Drugs Standard Control Organisation (CDSCO) regulates all medical devices under the Medical Device Rules (MDR) 2017. The Anaesthetic Gas Scavenging Terminal Unit is notified under entry 29/Misc/03/2020-DC(177), dated 12.07.2021, and is categorized as a Class A medical device, which is the lowest risk class.

Manufacturing and import of this device require compliance with MDR 2017, including obtaining the appropriate license before market entry.

Risk Classification and License Requirements

• Device Risk Class: Class A (Low Risk)
• License Type for Manufacturing: MD5 License (Form MD3)
• License Authority: State Licensing Authority
• Test License: MD13 Test License required before MD5 application
• License Type for Import: MD15 License (Form MD14)

Class A devices like the Anaesthetic Gas Scavenging Terminal Unit benefit from a streamlined licensing process but still require detailed documentation and adherence to quality management systems.

Manufacturing License Process (MD5)

1. Apply for Test License (MD13): Before manufacturing, obtain a test license, which takes approximately 1.5 to 2 months. This allows you to manufacture limited quantities for testing.
2. Product Testing: Get your device tested by government-approved laboratories. Testing typically includes safety and performance parameters relevant to anesthesiology devices.
3. Document Preparation: Prepare comprehensive documentation, including Device Master File, Plant Master File, Risk Management File, and other technical files.
4. Submit Application for MD5 License (Form MD3): Apply via the CDSCO MD Online Portal with the required documents.
5. Audit by Notified Body: A notified body will conduct an audit of your manufacturing facility and QMS. Refer to the Notified Bodies List for authorized auditors.
6. Resolve Queries: Address any observations or queries raised during the audit or by CDSCO officials.
7. Grant of License: Upon successful completion, the State Licensing Authority issues the MD5 manufacturing license.

Manufacturing License Documents Required

To ensure a smooth review, prepare the following documents meticulously:

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease of Manufacturing Premises
• Details of Technical Staff Qualifications and Experience
• Fire NOC and Pollution Control NOC
• Device Master File detailing design, specifications, and standards (Device Master File Guide)
• Plant Master File outlining manufacturing processes and quality control (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with safety and performance requirements
• Risk Management File demonstrating hazard analysis and mitigation (Risk Management)
• Test Reports from government-approved laboratories (Testing Laboratories)
• Labels and Instructions for Use (IFU) compliant with CDSCO guidelines
• Quality Management System Documents (ISO 13485:2016 certification recommended)

Import License Process (MD15)

If you are an importer of the Anaesthetic Gas Scavenging Terminal Unit, obtaining an MD15 import license is mandatory before bringing the device into India.

1. Document Preparation: Assemble import-specific documents such as Free Sale Certificate, ISO 13485:2016 certificate, CE Certificate, and manufacturing license from the country of origin.
2. Apply on CDSCO MD Online Portal: Submit the Form MD14 application along with supporting documents.
3. Queries and Clarifications: CDSCO may raise queries; prompt responses expedite approval.
4. Grant of Import License: The Central Licensing Authority issues the MD15 license, typically within 5-6 months.

Import License Documents Required

• Manufacturing License from Exporting Country
• Free Sale Certificate
• ISO 13485:2016 certification
• CE Certificate or other recognized regulatory approvals
• Device Master File and Plant Master File
• Wholesale License (if applicable)
• Company Constitution and Incorporation Documents

Timeline and Processing Duration

Timelines can vary based on the completeness of your submission and responsiveness to queries.

Government Fees and Costs

• MD5 Manufacturing License

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

• MD13 Test License: Fee included in the MD5 process

• MD15 Import License

  • Site Fee (Class A): Approximately $1,000 per site
  • Product Fee: Approximately $50 per product

These fees are payable online via the CDSCO portal.

Common Challenges and Solutions

• Incomplete Documentation: Many applicants face delays due to missing or inadequate technical files. We recommend thorough use of checklists and pre-submission audits.
• Delayed Product Testing: Government labs can have backlogs; consider planning testing early and explore labs listed on the Testing Laboratories page.
• Audit Non-Compliance: Not preparing your manufacturing site and QMS for notified body audits can cause rejection. Conduct internal pre-audits to mitigate risks.
• Regulatory Updates: Stay updated with CDSCO notifications to avoid surprises; we provide timely alerts to all our clients.

Expert Consultation and Support

Navigating CDSCO licensing for Class A devices like the Anaesthetic Gas Scavenging Terminal Unit requires expert insights to avoid costly delays. Our regulatory consultants have a proven track record of guiding manufacturers and importers through every step—from test license application to final license issuance.

We offer:

• Comprehensive document preparation and review
• Coordination with notified bodies and testing labs
• Audit readiness and QMS implementation support
• Personalized timelines and cost estimation

Our clients benefit from a tailored approach, ensuring compliance without unnecessary expenditure or time loss.

Getting Started with Your CDSCO License Application

1. Identify Your Licensing Needs: Determine whether you require a manufacturing or import license.
2. Gather Initial Documents: Start compiling company registration, premises proof, and technical staff details.
3. Plan for Test License (MD13): For manufacturers, initiate the test license application early to avoid delays.
4. Engage Expert Support Early: Leverage consultancy services to prepare Device Master Files and Plant Master Files accurately.
5. Register and Submit on CDSCO MD Online Portal: Use the official portal to submit your applications and track progress.
6. Schedule Product Testing: Contact approved government labs to book testing slots.
7. Prepare for Audit: Familiarize yourself with notified body requirements by reviewing the Notified Bodies List.

By following these actionable steps and leveraging our decades of regulatory expertise, your journey to obtaining a CDSCO license for the Anaesthetic Gas Scavenging Terminal Unit will be structured, efficient, and successful.

For detailed, personalized support or to initiate your application, contact us today and join over 500 satisfied clients who have successfully entered the Indian medical device market with our assistance.