CDSCO License for Cold-air therapy unit
Medical Device Information
Intended Use
Intended to reduce localized pain/inflammation, and/or to reduce thermal skin damage by applying cold stream of air during dermatological laser treatments.
Introduction to Cold-Air Therapy Unit and Its Regulatory Importance
Cold-air therapy units are specialized medical devices designed to deliver a controlled stream of cooled air to reduce localized pain and inflammation, particularly during dermatological laser treatments. Classified under the rehabilitation category, these devices play a crucial role in minimizing thermal skin damage and improving patient comfort. Given their clinical significance and potential risks, regulatory compliance with the Central Drugs Standard Control Organization (CDSCO) is mandatory for manufacturers and importers aiming to market cold-air therapy units in India.
Navigating the CDSCO licensing framework ensures that your device meets stringent safety, quality, and performance standards, fostering trust with healthcare providers and patients alike. With over 25 years of experience and having assisted 500+ companies, we provide you with a practical roadmap to secure your CDSCO license efficiently.
CDSCO Regulatory Framework for Cold-Air Therapy Units
Cold-air therapy units fall under the Class B risk category, as per the Medical Device Rules (MDR) 2017, due to their non-invasive nature but potential impact on patient safety if improperly used. The regulatory framework mandates compliance with various requirements including device testing, quality management systems, and audits before obtaining the manufacturing or import license.
The CDSCO acts as the regulatory authority, while the State Licensing Authority grants the manufacturing license for Class A and B devices. Import licenses and higher risk class licenses are handled centrally.
Risk Classification and License Requirements
According to the Medical Device Classification guidelines, your cold-air therapy unit is classified as Class B. Consequently, the applicable license is the MD5 manufacturing license (Application Form MD3) when manufacturing in India. This license is issued by the State Licensing Authority.
For importers, the relevant license is the MD15 import license issued by the Central Licensing Authority.
Manufacturing License Process (MD5) for Cold-Air Therapy Unit
The MD5 license process for Class B devices involves several critical steps:
Test License Application (Form MD13): Apply for a test license, permitting the manufacture and testing of the device. This phase typically takes 1.5 to 2 months.
Product Testing: Get the device tested at government-approved laboratories listed on the CDSCO Testing Laboratories page. Testing validates compliance with applicable standards.
Documentation Preparation: Compile comprehensive documentation including Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, and Risk Management File.
Application for Manufacturing License (Form MD3): Submit the manufacturing license application through the CDSCO MD Online Portal.
Audit by Notified Body: An audit from a notified body is mandatory, focusing on your quality management system and manufacturing facility. Refer to the Notified Bodies List to select an authorized auditor.
Resolution of Queries: Address any queries from CDSCO or the notified body promptly to avoid delays.
Grant of License: Upon successful review and compliance, the MD5 license is granted.
Overall, this process takes approximately 3 to 4 months from test license application to license grant.
Manufacturing License Documents Required
For the cold-air therapy unit MD5 license, you must prepare and submit the following documents:
- Company Constitution (Incorporation Certificate / Partnership Deed)
- Proof of Ownership/Rental Agreement of Manufacturing Premises
- Details of Technical Staff with Qualifications
- Fire NOC and Pollution Control Board NOC
- Device Master File covering design, specifications, and manufacturing process (detailed DMF guide)
- Plant Master File outlining facility layout and equipment (learn more about PMF)
- Essential Principles Checklist confirming compliance with safety and performance requirements
- Risk Management File demonstrating identification and mitigation of device-related risks (risk management insights)
- Test Reports from CDSCO-approved labs
- Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documentation, preferably ISO 13485 compliant
Ensuring these documents are thorough and accurate reduces back-and-forth with regulators.
Import License Process (MD15) for Cold-Air Therapy Unit
For importers of cold-air therapy units, the MD15 license is mandatory. The process is centralized and involves:
Document Preparation: Assemble required 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 Drug License, and Company Constitution.
Application Submission (Form MD14): File the import license application via the CDSCO MD Online Portal.
Query Resolution: Respond to any departmental queries in a timely manner.
License Issuance: Upon satisfaction, CDSCO issues the MD15 import license.
The import license process generally spans 5 to 6 months.
Import License Documents Required
Key documents for MD15 import license include:
- Valid Manufacturing License from the foreign manufacturer
- Free Sale Certificate from the country of origin
- ISO 13485:2016 Quality Management System Certificate
- CE Certificate or equivalent international certifications
- Device Master File and Plant Master File
- Wholesale Drug License for distribution within India
- Company Constitution and ownership proofs
Timely collection and verification of these documents expedite approval.
Timeline and Processing Duration
| Process Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | Varies, approx 1 month |
| Manufacturing License Application | 1 - 2 months |
| Audit and Query Resolution | 1 month |
| Total (MD5 License) | 3 - 4 months |
| Import License (MD15) | 5 - 6 months |
Being proactive in responding to queries and preparing detailed documentation can shorten these timelines.
Government Fees and Costs
For the MD5 manufacturing license (Class B device):
- Application Fee: ₹5,000
- Per Product Fee: ₹500
For the MD15 import license, fees vary by device class. For Class B devices, expect:
- Site Fee: Approximately $2,000
- Per Product Fee: Approximately $1,000
Additional costs include notified body audit fees, product testing fees at CDSCO-approved labs, and consultancy fees if engaged.
Common Challenges and Solutions
Challenge 1: Delays in Product Testing
- Solution: Engage with CDSCO-approved labs early and schedule testing appointments in advance.
Challenge 2: Incomplete Documentation
- Solution: Use comprehensive checklists covering DMF, PMF, risk management, and QMS documents. Refer to our Device Master File guide for detailed preparation.
Challenge 3: Audit Non-compliance
- Solution: Conduct internal audits prior to notified body visits. Ensure your facility meets GMP standards and your staff are trained.
Challenge 4: Query Response Delays
- Solution: Assign a dedicated regulatory affairs professional to monitor and respond promptly to CDSCO queries.
Expert Consultation and Support
With our extensive experience guiding over 500 companies through the CDSCO licensing maze, we understand the nuances specific to devices like cold-air therapy units. Our expert team offers:
- End-to-end license application management
- Documentation preparation and review
- Liaison with notified bodies and testing labs
- Training for compliance and audit readiness
Our hands-on support minimizes risk, reduces processing time, and ensures successful license grants.
Getting Started with Your CDSCO License Application
To initiate your CDSCO license application for your cold-air therapy unit, follow these actionable steps:
Evaluate Device Classification: Confirm your device is Class B and qualifies for MD5 license.
Register on the CDSCO MD Online Portal: Create your account and familiarize yourself with the platform.
Prepare the Test License Application (Form MD13): Gather preliminary documents and apply.
Engage a CDSCO-Approved Testing Laboratory: Schedule product testing early.
Compile Required Documentation: Use our detailed guides for DMF, PMF, and risk management files.
Select a Notified Body for Audit: Choose from the official list of notified bodies.
Submit Manufacturing License Application (Form MD3): Once testing and documentation are ready.
Prepare for Audit and Query Resolution: Coordinate with your notified body and regulatory consultants.
Obtain MD5 License and Begin Manufacturing: Ensure ongoing compliance post-license.
Starting early and partnering with experienced consultants can save months of time and prevent costly errors. Contact us today to leverage our expertise and get your cold-air therapy unit approved for the Indian market smoothly and efficiently.
