CDSCO License for Inflatable hot/cold therapy pack/electric pump
Medical Device Information
Intended Use
A assembly of devices intended for localized thermal and compression therapy to facilitate the treatment of a variety of adverse conditions resulting from musculoskeletal injury.
Comprehensive Guide to CDSCO Licensing for Inflatable Hot/Cold Therapy Packs (Class B)
At our consultancy, with over 25 years of experience and having successfully guided 500+ companies, we understand the nuances and critical requirements for obtaining your CDSCO license for medical devices like Inflatable Hot/Cold Therapy Packs and Electric Pumps. This device is classified as Class B under the pain management category, requiring a well-structured approach to compliance with India’s regulatory framework.
Understanding the Device and Its Regulatory Importance
Inflatable hot/cold therapy packs combined with electric pumps serve a vital role in localized thermal and compression therapy. These devices aid in treating musculoskeletal injuries by providing targeted pain relief and enhanced recovery. Given their therapeutic application and interaction with patients, regulatory oversight ensures safety, efficacy, and quality compliance before market entry.
CDSCO Regulatory Framework for Inflatable Hot/Cold Therapy Packs
In India, the Central Drugs Standard Control Organization (CDSCO) governs the regulation of medical devices. As per the Medical Device Rules 2017, Inflatable hot/cold therapy packs fall under Class B (low-moderate risk), which mandates obtaining an MD5 manufacturing license granted by the State Licensing Authority.
Risk Classification and License Requirements
- Device Class: B (Low to Moderate Risk)
- License Type: MD5 Manufacturing License
- Application Form: MD3
- Regulatory Authority: State Licensing Authority (SLA)
- Testing: Mandatory from CDSCO-approved labs
This classification necessitates manufacturers to comply with essential principles, risk management, and quality management systems tailored for Class B devices.
MD5 Manufacturing License Process for Inflatable Hot/Cold Therapy Packs
The end-to-end licensing process typically spans 3 to 4 months and involves the following key steps:
- Obtain Test License (Form MD13): Initial test license required for product testing. Processing time is approximately 1.5 to 2 months.
- Product Testing: Conducted at government-approved testing laboratories to validate safety and performance.
- Documentation Preparation: Compile Device Master File (DMF), Plant Master File (PMF), Risk Management File, Essential Principles Checklist, and Quality Management System (QMS) documents.
- License Application Submission (Form MD3): File through the CDSCO MD Online Portal.
- Audit by Notified Body: State-level audit conducted by notified bodies listed here.
- Resolution of Queries: Address any observations or requests for additional information.
- Grant of License (Form MD5): Upon successful audit and compliance verification.
Documents Required for MD5 Manufacturing License
Successful applications for Inflatable hot/cold therapy packs must include:
- Company Constitution (Incorporation Certificate, MOA, AOA)
- Proof of Ownership or Lease of Manufacturing Premises
- Details and Qualifications of Technical Staff
- Fire NOC and Pollution Control Board Clearance
- Device Master File (DMF): Detailed device description, manufacturing process, specifications, and validation (Guide here)
- Plant Master File (PMF): Documentation of manufacturing facility, equipment, and quality control (Guide here)
- Essential Principles Compliance Checklist
- Risk Management File demonstrating hazard identification and mitigation (Risk Management Practices)
- Test Reports from CDSCO-Approved Labs (Testing Labs List)
- Finished Product Labels and Instructions for Use (IFU)
- Quality Management System Documents (ISO 13485:2016 preferred)
Import License Process (MD15) for Inflatable Hot/Cold Therapy Packs
If you are importing this device into India, an MD15 import license is mandatory. This license is granted by the Central Licensing Authority and usually takes 5 to 6 months. The steps include:
- Document preparation including existing manufacturing license, Free Sale Certificate from country of origin, ISO 13485, CE Certificate
- Application submission via the CDSCO MD Online Portal
- Resolution of queries from CDSCO
- License grant on Form MD15
Required documents include the manufacturing license, QMS certificates, device and plant master files, wholesale license, and company constitution.
Timeline and Processing Duration
| Step | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 2 - 3 weeks |
| Documentation Preparation | 2 - 3 weeks |
| Application & Audit | 1 - 1.5 months |
| Query Resolution | 2 - 4 weeks |
| Total | 3 - 4 months |
Government Fees and Costs
- Application Fee for MD5 License: INR 5,000 per application
- Product Fee: INR 500 per product
- Additional costs may include testing fees charged by government-approved labs and audit fees by notified bodies.
Common Challenges and Practical Solutions
Challenge: Delays in test report acquisition due to backlog at testing labs.
Solution: Schedule testing early post-test license issuance and consider multiple approved labs to reduce waiting times.
Challenge: Incomplete or inconsistent documentation causing audit queries.
Solution: Engage in pre-audit document review and follow our structured checklists for DMF and PMF preparation.
Challenge: Confusion over device classification leading to incorrect application forms.
Solution: Confirm device classification using CDSCO guidelines and consult with regulatory experts to ensure the correct license application.
Expert Consultation and Support
Navigating CDSCO licensing can be complex, especially for specialized devices like Inflatable hot/cold therapy packs. Our team offers hands-on assistance from initial classification and documentation to audit preparation and query resolution. We have a proven track record of expediting approvals and minimizing regulatory risks.
Getting Started with Your CDSCO License Application
- Assess Your Device Classification: Confirm that your product fits Class B criteria.
- Prepare Test License Application: File Form MD13 through the CDSCO MD Online Portal to initiate product testing.
- Plan Testing Schedule: Engage CDSCO-approved testing laboratories early.
- Compile Comprehensive Documentation: Develop your Device Master File and Plant Master File using our detailed guides.
- Submit Manufacturing License Application: Apply for MD5 license using Form MD3 on the portal.
- Prepare for Audit: Coordinate with a notified body for your audit and ensure compliance readiness.
By following these actionable steps and leveraging expert advice, manufacturers and importers can streamline their regulatory journey, ensuring timely market access for their Inflatable hot/cold therapy packs in India.
For tailored support and further information, feel free to contact our regulatory consultancy team who specialize in CDSCO medical device licensing.
