CDSCO License for Anaesthetic gas absorption/desorption device

Comprehensive Guide to CDSCO Licensing for Anaesthetic Gas Absorption/Desorption Devices (Class B)

As seasoned regulatory consultants with over 25 years of experience and having assisted 500+ companies in navigating the complex Indian medical device landscape, we understand the unique challenges manufacturers and importers face. If you’re aiming to market an Anaesthetic Gas Absorption/Desorption Device in India—a Class B anesthesiology medical device—you must comply with the Central Drugs Standard Control Organization (CDSCO) regulations to ensure safety, efficacy, and legal market access.

Understanding the Anaesthetic Gas Absorption/Desorption Device and Its Regulatory Importance

This device plays a critical role in anesthesiology by absorbing and desorbing volatile anesthetic agents within a breathing circuit, effectively recycling exhaled gases. Given its direct interaction with patients during anesthesia, regulatory oversight is stringent to minimize risks related to gas toxicity or malfunction.

The device is notified under CDSCO Notification No. 29/Misc/03/2020-DC(177) dated 12.07.2021. Compliance with CDSCO’s licensing framework is mandatory for manufacturing or importing this device in India.

CDSCO Regulatory Framework for Anaesthetic Gas Absorption/Desorption Devices

India categorizes medical devices into four risk classes (A, B, C, and D) based on potential risk to patients. Your device falls under Class B, which includes low-to-moderate risk devices. This classification determines the licensing authority and the application process.

For Class B devices, the MD5 Manufacturing License is applicable for manufacturers, issued by the State Licensing Authority. Importers require the MD15 Import License granted by the Central Licensing Authority.

Risk Classification and License Requirements for Class B Devices

• License Type: MD5 (Manufacturing) and MD15 (Import)
• Regulatory Authority: State Authority for MD5; Central Authority for MD15
• Application Forms: MD3 for MD5 Manufacturing License; MD14 for MD15 Import License
• Testing: Mandatory product testing at CDSCO-approved laboratories
• Audit: Required by a notified body for manufacturing licenses

You can verify your device’s classification and regulatory requirements through CDSCO’s Medical Device Classification resource.

Manufacturing License Process (MD5) for Anaesthetic Gas Absorption/Desorption Devices

Obtaining the MD5 License involves a multi-step process:

1. Test License (Form MD13): Apply for a test license, which typically takes 1.5 to 2 months. This license permits you to manufacture the device for testing purposes.
2. Product Testing: Conduct mandatory testing in government-approved labs. Refer to the CDSCO Testing Laboratories list to select a lab.
3. Document Preparation: Compile technical documents including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and Quality Management System (QMS) documents.
4. License Application (Form MD3): File the MD5 application via the CDSCO MD Online Portal after successful testing.
5. Audit by Notified Body: A mandatory audit by a notified body, which you can identify from the Notified Bodies List.
6. Query Resolution: Address any queries or clarifications raised during the audit or by CDSCO authorities.
7. License Grant: Upon satisfactory compliance, the MD5 license is granted.

Manufacturing License Documents Required

• Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
• Proof of Ownership or Lease of Manufacturing Premises
• Details of Qualified Technical Staff
• Fire No-Objection Certificate (NOC) and Pollution NOC
• Device Master File (DMF) – detailed device design and specifications (guide here)
• Plant Master File (PMF) – manufacturing processes and facilities (guide here)
• Essential Principles Checklist confirming compliance with Indian Medical Device Rules
• Risk Management File demonstrating hazard identification and mitigation (risk management guide)
• Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System documents (ISO 13485 certification is advantageous)

Import License Process (MD15) for Anaesthetic Gas Absorption/Desorption Devices

For importers, the MD15 license is mandatory and granted by the Central Licensing Authority. The process includes:

1. Document Preparation: Gather documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE certificate if applicable, Device Master File, Plant Master File, wholesale license, and company constitution.
2. License Application (Form MD14): Submit the application on the CDSCO MD Online Portal.
3. Query Resolution: Respond promptly to any CDSCO queries.
4. License Grant: Upon fulfillment of all requirements, the MD15 import license is issued.

Import License Documents Required

• Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License
• Company Constitution

Timeline and Processing Duration

• MD5 Manufacturing License: Approximately 3 to 4 months, including 1.5 to 2 months for test license and product testing.
• MD15 Import License: Approximately 5 to 6 months.

These timelines depend heavily on the completeness of documentation, responsiveness to queries, and audit scheduling.

Government Fees and Costs

• MD5 License: Rs. 5,000 per application plus Rs. 500 per product.
• MD15 Import License: For Class B devices, Rs. 2,000 per site and Rs. 1,000 per product.

Additional costs may include:

• Testing fees at approved laboratories
• Notified body audit fees
• Consulting fees if you engage expert help

Common Challenges and Solutions

Challenge 1: Delays in Testing and Audit Scheduling

• Solution: Begin test license application early and coordinate with CDSCO-approved labs promptly. Maintain proactive communication with notified bodies to schedule audits.

Challenge 2: Document Gaps and Non-Compliance

• Solution: Utilize comprehensive checklists and expert reviews to ensure your Device Master File, Plant Master File, and Risk Management documentation meet CDSCO expectations.

Challenge 3: Query Resolution Delays

• Solution: Address CDSCO and audit queries with detailed, evidence-backed responses promptly to avoid processing bottlenecks.

Expert Consultation and Support

Navigating CDSCO licensing can be complex, especially for Class B anesthesiology devices with patient safety implications. Our team offers tailored support including:

• End-to-end documentation preparation
• Assistance with test license applications and product testing coordination
• Guidance on audit readiness and liaison with notified bodies
• Regulatory strategy for import licensing

Our extensive track record ensures faster approvals and fewer rejections.

Getting Started with Your CDSCO License Application

To begin, we recommend:

1. Register on the CDSCO MD Online Portal and familiarize yourself with the submission process.
2. Conduct a gap analysis of your current technical and quality documentation against CDSCO requirements.
3. Select an approved testing laboratory early to schedule product testing.
4. Prepare your Device Master File and Plant Master File in line with CDSCO guidelines.
5. Engage with a notified body for pre-audit consultation to ensure compliance readiness.

By following these actionable steps, you can streamline your path to obtaining the MD5 manufacturing license or MD15 import license for your Anaesthetic Gas Absorption/Desorption Device and confidently enter the Indian market.

For detailed assistance, feel free to contact our expert regulatory consultants who have successfully secured licenses for hundreds of medical device manufacturers and importers across India.