CDSCO License for Medical gas terminal unit

Comprehensive Guide to CDSCO Licensing for Medical Gas Terminal Units (Class A)

Medical gas terminal units play a critical role in anesthesiology by serving as the interface between medical gas pipeline systems and medical devices. Given their essential function in delivering specific gases safely in healthcare settings, regulatory compliance is paramount. In India, the Central Drugs Standard Control Organization (CDSCO) governs the approval and licensing of such medical devices under the Medical Device Rules, 2017.

With over 25 years of experience assisting 500+ companies navigate the CDSCO licensing process, we provide here a detailed, practical guide tailored specifically for manufacturers and importers of Medical Gas Terminal Units classified as Class A devices.

CDSCO Regulatory Framework for Medical Gas Terminal Units

The Medical Gas Terminal Unit falls under the anesthesiology category and is notified under regulatory notification 29/Misc/03/2020-DC(177), dated 12.07.2021. As a Class A medical device, it is subject to the least stringent regulatory controls compared to higher-risk devices but still requires a thorough licensing process to ensure safety and compliance.

The manufacturing license for Class A devices is granted by the State Licensing Authority through the MD5 license process. Importers must obtain an MD15 import license from the Central Licensing Authority.

For detailed classification guidance, you can refer to the Medical Device Classification by CDSCO.

Risk Classification and License Requirements for Medical Gas Terminal Units

• Risk Class: Class A (Low risk)
• License Type: MD5 Manufacturing License for domestic manufacturers
• Licensing Authority: State Licensing Authority
• Import License: MD15 from Central Licensing Authority for importers

Class A devices like Medical Gas Terminal Units require:

• An initial test license (Form MD13) for testing product samples
• Product testing from CDSCO-approved government laboratories
• Audit by a notified body

You can check the list of notified bodies authorized for MD5 audits.

Manufacturing License Process (MD5) for Medical Gas Terminal Units

The stepwise process for obtaining an MD5 license for Medical Gas Terminal Units is as follows:

1. Apply for Test License (Form MD13): Submit your application on the CDSCO MD Online Portal to obtain a test license. This license authorizes you to manufacture limited quantities for testing purposes. Expect a processing time of 1.5 to 2 months.

2. Product Testing: Get your Medical Gas Terminal Units tested at CDSCO-recognized government labs. Testing ensures compliance with essential principles and safety requirements. See the list of testing laboratories for authorized facilities.

3. Document Preparation: Compile all required documentation including Device Master File (DMF), Plant Master File (PMF), risk management files, labeling, and instructions for use.

4. Apply for Manufacturing License (Form MD3): Submit this application with all documents and test reports.

5. Notified Body Audit: A third-party audit of your manufacturing facility and quality management system will be conducted.

6. Resolve Queries: Address any observations or queries raised by the licensing authority or notified body promptly.

7. Grant of License (Form MD5): Upon satisfactory completion of audit and document review, the manufacturing license is granted.

For a detailed walkthrough of the MD5 license process, refer to our MD5 License Guide.

Manufacturing License Documents Required for Medical Gas Terminal Units

To ensure a smooth application process, prepare the following key documents:

• Company Constitution (Incorporation Certificate, Partnership Deed, etc.)
• Proof of ownership or lease of manufacturing premises
• Details and qualifications of technical staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing design, specifications, and manufacturing process
• Plant Master File (PMF) describing manufacturing facility and equipment
• Essential Principles Compliance Checklist
• Risk Management File demonstrating hazard analysis and mitigation
• Product Test Reports from government-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System documentation (ISO 13485:2016 recommended)

Our comprehensive Device Master File guide and Plant Master File guide can assist in preparing these critical documents.

Import License Process (MD15) for Medical Gas Terminal Units

Importers wishing to bring Medical Gas Terminal Units into India must obtain an MD15 import license from the Central Licensing Authority. The process includes:

• Document preparation including Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, DMF, PMF, Wholesale License, and Company Constitution
• Submission of application on the CDSCO MD Online Portal
• Review and queries from CDSCO
• Grant of Import License (Form MD15)

Typically, the import license process takes approximately 5-6 months.

For more detailed information, see our Import License Guide.

Timeline and Processing Duration

Planning your project timeline with these durations in mind helps avoid costly delays.

Government Fees and Costs for Medical Gas Terminal Units

• MD5 Manufacturing License:

  • Application Fee: INR 5,000
  • Per Product Fee: INR 500

• MD15 Import License:

  • Class A Site Fee: $1000
  • Per Product Fee: $50

These fees are paid via the CDSCO online portal and are non-refundable.

Common Challenges and Practical Solutions

Challenge: Delays in test license approval and product testing.

Solution: Initiate test license application early and schedule testing promptly with government-approved laboratories. Proactively prepare documents to avoid multiple rounds of queries.

Challenge: Preparing comprehensive Device Master and Plant Master Files.

Solution: Utilize expert guidance and templates to create detailed, compliant DMFs and PMFs. Our guides offer practical tips to streamline this process.

Challenge: Audit readiness and quality management system gaps.

Solution: Conduct internal audits and mock inspections to identify gaps. Implement ISO 13485:2016 QMS to demonstrate compliance.

Expert Consultation and Support

With our extensive regulatory experience and a successful track record of 500+ CDSCO license approvals, we provide:

• End-to-end application management
• Documentation review and preparation support
• Coordination with notified bodies and government labs
• Audit readiness training
• Post-approval compliance guidance

Partnering with expert consultants can significantly reduce your time-to-market and regulatory risk.

Getting Started with Your CDSCO License Application for Medical Gas Terminal Units

1. Determine your device classification and licensing route. Confirm that Medical Gas Terminal Unit is Class A under the latest CDSCO notification.

2. Register on the CDSCO MD Online Portal. This is mandatory for all license applications.

3. Apply for the Test License (Form MD13) promptly to avoid initial delays.

4. Begin preparing your Device Master File, Plant Master File, and Risk Management documentation. Utilize our detailed guides to ensure completeness.

5. Schedule testing of your product at a CDSCO-approved laboratory as soon as the test license is granted.

6. Engage with a notified body early for audit scheduling.

7. Maintain clear communication with CDSCO authorities and respond promptly to queries.

By following these practical steps and leveraging expert assistance, you position your Medical Gas Terminal Unit for timely regulatory approval and successful market entry in India.

For further assistance, feel free to reach out to our regulatory experts who have guided numerous manufacturers through the CDSCO process with efficiency and confidence.