CDSCO License for Environmental chamber for storage of platelet concentrate

Introduction to Environmental Chamber for Storage of Platelet Concentrate and Regulatory Importance

An environmental chamber for storage of platelet concentrate is a critical medical device designed to maintain platelet-rich plasma at a precise refrigerated temperature range. This ensures the viability and safety of platelets used in transfusion therapies. Classified as a Class B device under the CDSCO framework, it falls into the category of General Hospital or Orthopaedic Instruments as per Notification 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022.

For manufacturers and importers aiming to launch this device in India, adhering to CDSCO’s stringent regulatory requirements is essential to guarantee product quality, safety, and market access. Given the sensitive nature of the device’s intended use, regulatory compliance not only protects patient safety but also strengthens market credibility.

CDSCO Regulatory Framework for Environmental Chambers (Class B)

The Central Drugs Standard Control Organisation (CDSCO) regulates medical devices in India under the Medical Device Rules, 2017. Environmental chambers for platelet concentrate storage are classified as Class B devices, which typically require a Manufacturing License (MD5) granted by the State Licensing Authority.

The regulatory framework mandates comprehensive documentation, product testing, and facility audits before license approval. This ensures that the device meets essential principles of safety and performance outlined by CDSCO.

Risk Classification and License Requirements

As a Class B device, the environmental chamber falls into the low-moderate risk category. This classification influences the licensing pathway:

• Manufacturing License: MD5 License (Application Form MD3) via State Authority
• Import License: MD15 License (Application Form MD14) via Central Authority (if applicable)

The MD5 process involves obtaining a Test License (MD13) first, followed by product testing, documentation submission, audit, and final license grant.

For detailed classification criteria, manufacturers can refer to the Medical Device Classification.

Manufacturing License Process for Environmental Chamber (MD5 License)

The MD5 license process for Class B devices includes the following key steps:

1. Apply for Test License (MD13): Initiate the process by applying for a test license via Form MD13 on the CDSCO MD Online Portal. This license permits the manufacture of the device for testing purposes.

2. Product Testing: Conduct product testing at government-approved laboratories to ensure compliance with applicable standards. A list of Testing Laboratories is available on the CDSCO portal.

3. Documentation Preparation: Compile all required documents such as Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.

4. Submit MD5 Application (Form MD3): File the application for manufacturing license with all necessary documents via the CDSCO MD Online Portal.

5. Audit by Notified Body: Undergo a mandatory audit by a notified body to verify compliance with quality management systems and manufacturing practices. Refer to the Notified Bodies List for eligible auditors.

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

7. Grant of License (Form MD5): Upon successful completion of all requirements, the State Licensing Authority grants the manufacturing license.

For a detailed stepwise guide, access our comprehensive MD5 License Guide.

Manufacturing License Documents Required for Environmental Chamber

Manufacturers must prepare a thorough documentation package including:

• Company Constitution Documents (Incorporation Certificate, PAN)
• Proof of Ownership/Lease of Manufacturing Premises
• Qualification and Experience Documents of Technical Staff
• Fire Safety NOC and Pollution Control Board NOC
• Device Master File detailing device design, specifications, and manufacturing processes (Device Master File Guide)
• Plant Master File covering facility layout, equipment, and utilities (Plant Master File Guide)
• Essential Principles Checklist confirming compliance to safety and performance requirements
• Risk Management File demonstrating hazard analysis and mitigations (Risk Management)
• Test Reports from government-approved laboratories
• Labels, Instructions for Use (IFU)
• Quality Management System (QMS) Documents aligned with ISO 13485:2016

Import License Process for Environmental Chamber (MD15 License)

Importers of this Class B environmental chamber require an MD15 import license issued by the Central Licensing Authority. The process involves:

1. Document Preparation: Gather necessary documents including manufacturing license, Free Sale Certificate, ISO and CE certificates, Device and Plant Master Files.

2. Application Submission: Apply using Form MD14 on the CDSCO MD Online Portal.

3. Departmental Review and Queries: Respond to any clarifications or additional document requests.

4. Grant of Import License (Form MD15): Upon satisfactory evaluation, the license is issued.

For comprehensive guidance, see our Import License Guide.

Import License Documents Required

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

Timeline and Processing Duration

• Test License (MD13): Approximately 1.5 to 2 months
• Product Testing: 2 to 3 weeks depending on laboratory backlog
• Documentation Preparation: Variable, typically 2 to 4 weeks
• MD5 License Application Processing: 1.5 to 2 months including notified body audit and query resolution

Total time for MD5 license: Approximately 3 to 4 months from start to finish.

For import license (MD15), expect around 5 to 6 months due to central authority processing.

Government Fees and Costs

For Class B device manufacturing license (MD5):

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

Additional costs include notified body audit fees (varies by auditor), product testing fees at government labs, and internal costs for document preparation and quality system implementation.

Budgeting for approximately Rs. 1.5 to 2 lakhs overall is prudent to cover these expenses.

Common Challenges and Solutions

• Delays in Product Testing: To avoid bottlenecks, submit samples early and choose testing labs with faster turnaround times. Prioritize labs listed on the CDSCO portal.

• Incomplete Documentation: Use checklists and templates from trusted regulatory consultants to ensure all documents such as Device Master File and Risk Management File are accurate and complete.

• Audit Non-compliance: Prepare your facility and QMS rigorously before audit. Conduct internal mock audits to identify gaps.

• Query Resolution Delays: Assign dedicated personnel to respond promptly to CDSCO queries to maintain process momentum.

Expert Consultation and Support

With over 25 years of experience assisting 500+ companies in navigating CDSCO licensing, we offer tailored support for environmental chamber manufacturers. Our services include:

• Documentation drafting and review
• Regulatory strategy and classification advice
• Coordination with notified bodies and testing labs
• End-to-end application submission and follow-up

Partnering with experienced consultants can significantly reduce approval timelines and prevent costly rejections.

Getting Started with Your CDSCO License Application

To initiate your CDSCO MD5 license application for the environmental chamber:

1. Register on the CDSCO MD Online Portal to create your company profile.

2. Apply for the Test License (MD13) to legally manufacture products for testing.

3. Collect product samples and send them to approved testing laboratories.

4. Prepare all mandatory documents, leveraging our guides on Device and Plant Master Files.

5. Schedule and prepare for the notified body audit by reviewing the Notified Bodies List.

6. Submit your MD5 license application (Form MD3) once test reports and audit certificates are ready.

7. Maintain active communication with CDSCO officers to address queries swiftly.

Starting early and following a structured approach will ensure a smoother path to obtaining your CDSCO manufacturing license, enabling you to enter India’s expanding medical device market confidently.