CDSCO License for Hyperbaric chamber

Comprehensive Guide to CDSCO Licensing for Hyperbaric Chambers (Class C Medical Device)

As seasoned regulatory consultants with over 25 years of experience and having supported 500+ medical device manufacturers and importers, we understand the challenges involved in navigating India's regulatory landscape. This guide is tailored specifically for Hyperbaric Chambers, classified as Class C devices under the Respiratory category, intended for administering 100% oxygen at pressures above ambient. We will walk you through every critical step in obtaining your CDSCO license, ensuring your product meets all legal requirements and enters the Indian market seamlessly.

Understanding the Hyperbaric Chamber and Its Regulatory Importance

A Hyperbaric Chamber is a sophisticated medical device used clinically to deliver pure oxygen under increased atmospheric pressure. Its applications span critical care, wound healing, and treatment of decompression sickness. Due to its nature and risk profile, the Government of India classifies it as a Class C device, demanding stringent compliance with safety, quality, and performance standards. Securing a CDSCO MD9 manufacturing or import license is mandatory before commercializing this device in India.

CDSCO Regulatory Framework for Hyperbaric Chambers (Class C)

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India, categorizing devices per risk:

• Class A & B (Low to Moderate Risk): Licenses granted by State Authorities (MD5 License)
• Class C & D (High Risk): Licenses granted by the Central Licensing Authority (MD9 License for manufacturing, MD15 for import)

Since Hyperbaric Chambers fall under Class C, the manufacturer must apply for an MD9 license through CDSCO's centralized process.

Risk Classification and License Requirements for Hyperbaric Chambers

• Risk Class: C (High risk due to pressurized oxygen delivery)
• License Type: MD9 Manufacturing License (Form MD7)
• Regulatory Authority: Central Licensing Authority, CDSCO
• Notification Reference: File No. 29/Misc/03/2020-DC(197), dated 6.8.2021

For importers, an MD15 Import License (Form MD14) is required.

Manufacturing License Process (MD9) for Hyperbaric Chambers

The MD9 licensing process is comprehensive, involving several critical stages:

1. Obtain Test License (Form MD13): Before full license application, apply for a test license to legally manufacture limited quantities for testing. This phase typically takes 1.5 to 2 months.

2. Product Testing: Conduct mandatory testing of the Hyperbaric Chamber at Government-approved laboratories. Testing includes safety, performance, and biocompatibility assessments relevant to Class C devices. Refer to the list of testing laboratories authorized by CDSCO.

3. Documentation Preparation: Gather and prepare a comprehensive set of documents (detailed in the next section).

4. Application Submission: Submit the MD9 license application (Form MD7) via the CDSCO MD Online Portal.

5. Audit by CDSCO Inspectors: The CDSCO will conduct an on-site audit of your manufacturing facility and quality management systems to ensure compliance.

6. Query Resolution: Address any queries or deficiencies raised by CDSCO or auditors promptly.

7. Grant of License: Upon satisfactory review, the MD9 license will be granted (Form MD9).

Manufacturing License Documents Required for Hyperbaric Chambers

The documentation package for the MD9 license is detailed and must demonstrate strict adherence to regulatory requirements:

• Company Constitution Documents: Incorporation certificate, memorandum and articles of association.
• Proof of Ownership or Lease Agreement of Manufacturing Premises.
• Technical Staff Qualifications: Details of qualified technical personnel responsible for manufacturing.
• Fire No Objection Certificate (NOC).
• Pollution Control Board NOC.
• Device Master File (DMF): Including design, manufacturing process, specifications, and validation data. Our detailed Device Master File guide can assist with preparation.
• Plant Master File (PMF): Details on facility layout, environment controls, equipment, and maintenance. Learn more from our Plant Master File guide.
• Essential Principles Checklist: Compliance matrix with Indian regulatory requirements.
• Risk Management File: Comprehensive risk analysis and mitigation strategies conforming to ISO 14971 standards. See our insights on Risk Management.
• Test Reports: From government-approved labs covering all required tests.
• Product Labels and Instructions for Use (IFU): Clearly indicating usage, warnings, and manufacturer details.
• Quality Management System (QMS) Documents: Typically ISO 13485:2016 certification and related SOPs.

Import License Process (MD15) for Hyperbaric Chambers

For importers seeking to bring Hyperbaric Chambers into India, the MD15 license process is as follows:

1. Document Preparation: Collect comprehensive documents including the manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate (if applicable), DMF, PMF, wholesale license, and company constitution.

2. Application Submission: File Form MD14 application through the CDSCO MD Online Portal.

3. Query Resolution: Respond to any CDSCO queries.

4. Grant of Import License: Upon approval, the MD15 license is issued.

Notably, a test license is not required for imports.

Import License Documents Required

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

Timeline and Processing Duration for Hyperbaric Chambers

These timelines include regulatory review periods and audit schedules but can vary depending on the completeness of submissions and responsiveness to queries.

Government Fees and Costs for MD9 License

• Application Fee: ₹50,000 per application
• Per Product Fee: ₹1,000 per product

Additional costs include:

• Testing fees payable to government-approved labs (varies by tests)
• Audit fees (incurred if engaging notified bodies)
• Preparation costs for documentation, risk management, and quality systems

For imports (MD15), fees depend on risk class and number of products, e.g., Class C devices attract ₹3,000/site and ₹1,500/product.

Common Challenges and Practical Solutions

• Delayed Test Reports: Coordinate early with approved labs to schedule testing, avoiding bottlenecks.

• Incomplete Documentation: Utilize expert guidance to prepare comprehensive DMFs and PMFs. Refer to our Device Master File guide and Plant Master File guide for templates.

• Audit Non-compliance: Conduct pre-audit internal assessments and staff training to ensure readiness.

• Query Management: Maintain prompt and clear communication with CDSCO authorities.

Expert Consultation and Support

With decades of experience and over 500 successful CDSCO license applications, our consultancy offers:

• Tailored regulatory strategy for Hyperbaric Chambers
• End-to-end document preparation and review
• Liaison with CDSCO and notified bodies
• Audit preparedness training
• Post-approval compliance support

Getting Started with Your CDSCO License Application for Hyperbaric Chambers

1. Assess Your Device Classification: Confirm your Hyperbaric Chamber is Class C as per the Medical Device Classification.

2. Register on CDSCO MD Online Portal: Create your account at the CDSCO MD Online Portal to initiate your application.

3. Prepare Test License Application: Apply for the MD13 test license to legally begin manufacturing sample units for testing.

4. Engage Approved Testing Labs: Schedule necessary tests early by consulting the Testing Laboratories list.

5. Compile Documentation: Utilize our guides and templates to prepare the DMF, PMF, risk management files, and QMS documents.

6. Plan for Audit: Contact CDSCO or authorized notified bodies for pre-audit consultations.

7. Submit MD9 Application: Once testing and documentation are complete, submit your MD9 license application.

By following these structured steps and leveraging expert support, you can significantly reduce delays and ensure regulatory compliance for your Hyperbaric Chamber in India. For personalized assistance and turnkey solutions, reach out to our consultancy to jumpstart your CDSCO licensing journey.