CDSCO License for Endothermic cold therapy pack

Comprehensive Guide to CDSCO Licensing for Endothermic Cold Therapy Packs (Class B Medical Device)

As a trusted regulatory consultancy with over 25 years of experience and having supported more than 500 companies to successfully navigate the CDSCO licensing process, we understand the nuanced requirements for bringing an Endothermic Cold Therapy Pack to the Indian market. This device, classified as Class B under CDSCO guidelines, is used for pain management by applying cold therapy to reduce fever, pain, and inflammation in joints, muscles, or minor burns. Compliance with CDSCO regulations ensures that your product meets quality and safety standards, allowing smooth market entry.

CDSCO Regulatory Framework for Endothermic Cold Therapy Packs

The Central Drugs Standard Control Organization (CDSCO) regulates all medical devices in India under the Medical Device Rules (MDR) 2017. Your device falls under Class B (Low-Moderate Risk), which requires a manufacturing license known as MD5, issued by the State Licensing Authority. The regulation aims to safeguard public health by enforcing strict quality control and compliance with essential principles.

Risk Classification and License Requirements

Your Endothermic Cold Therapy Pack is a Class B device due to its intended use that involves direct contact with the body surface but poses low to moderate risk. The licensing pathway includes:

• Manufacturing License: MD5 License (Form MD3)
• Test License: MD13 (mandatory prerequisite for testing before manufacturing license application)
• Authority: State Licensing Authority
• Total Timeline: Approximately 3 to 4 months

For detailed risk classification, refer to the Medical Device Classification guide.

Manufacturing License Process (MD5)

1. Apply for Test License (Form MD13): This is the first step to legally conduct product testing. The test license is valid for 6 months and typically takes 1.5 to 2 months to be granted.
2. Product Testing: Get your Endothermic Cold Therapy Packs tested at CDSCO-approved testing laboratories to demonstrate compliance with Essential Principles. A list of approved testing laboratories is available for your reference.
3. Documentation Preparation: Prepare comprehensive files including Device Master File (DMF), Plant Master File (PMF), Risk Management File, and Quality Management System (QMS) documents.
4. Apply for Manufacturing License (Form MD3): Submit your application via the CDSCO MD Online Portal along with required documents and fees.
5. Audit by Notified Body: An audit is conducted by a notified body to verify QMS compliance. You can check the list of notified bodies authorized to conduct audits.
6. Resolution of Queries: Address any observations or queries raised by the department or notified body promptly.
7. Grant of License (Form MD5): Once all conditions are met, the State Licensing Authority issues the MD5 license.

Manufacturing License Documents Required

For the Endothermic Cold Therapy Pack, ensure you have the following ready:

• Company Constitution/Registration Certificate
• Proof of ownership or lease agreement of manufacturing premises
• Qualification documents of technical staff
• Fire NOC and Pollution Control Board clearance
• Device Master File (detailed design and manufacturing process) – see our Device Master File guide
• Plant Master File (equipment, environment, processes) – refer to our Plant Master File guide
• Essential Principles Compliance Checklist
• Risk Management File demonstrating hazard analysis and mitigation per Risk Management guidelines
• Test Reports from CDSCO-approved labs
• Labels and Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485 certification recommended)

Import License Process (MD15)

If you plan to import Endothermic Cold Therapy Packs into India, the process differs:

• The import license MD15 is issued by the Central Licensing Authority.
• The application is submitted on Form MD14 via the CDSCO MD Online Portal.
• Required documents include Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE Certificate, Device Master File, Plant Master File, Wholesale License, and Company Constitution.
• The process typically takes 5 to 6 months.

For more on imports, consult our Import License Guide.

Import License Documents Required

• Valid manufacturing license from the country of origin
• Free Sale Certificate (FSC)
• ISO 13485:2016 certification
• CE Marking Certificate (if applicable)
• Detailed Device Master File
• Plant Master File
• Wholesale Drug License
• Company Constitution documents
• Other regulatory approvals or certificates as applicable

Timeline and Processing Duration

Government Fees and Costs

• Test License (MD13): No separate fees, but testing charges apply as per lab rates.
• MD5 Manufacturing License: Rs. 5,000 per application plus Rs. 500 per product (for your Endothermic Cold Therapy Pack).
• Product Testing Fees: Varies by lab and number of tests; budget approximately Rs. 50,000 – Rs. 1,00,000.
• Audit Fees: As per notified body charges, typically Rs. 30,000 – Rs. 60,000.

Budgeting these costs upfront will streamline your project planning.

Common Challenges and Solutions

• Delayed Test Reports: Coordinate early with CDSCO-approved labs and submit samples promptly to avoid bottlenecks.
• Incomplete Documentation: Utilize checklists and expert reviews to ensure all documents, including DMF and PMF, meet CDSCO standards.
• Audit Non-Compliance: Conduct internal audits and mock inspections before notified body visits.
• Regulatory Queries: Engage proactively with CDSCO officers and provide clear, detailed responses.

Our practical experience allows us to help clients navigate these pain points smoothly.

Expert Consultation and Support

Our seasoned team offers end-to-end support from initial classification to license grant. We help prepare customized Device and Plant Master Files, manage test license procurement, coordinate product testing, and ensure compliance with ISO 13485 and Essential Principles.

For a deep dive into the MD5 licensing process for Class A and B devices, review our detailed MD5 License Guide.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your device is Class B using CDSCO guidelines.
2. Gather Documents: Start compiling company registration, premises proof, and technical staff credentials.
3. Develop Device & Plant Master Files: Use available online resources and our guides to draft comprehensive files.
4. Apply for Test License: Submit Form MD13 on the CDSCO MD Online Portal to commence testing legally.
5. Schedule Product Testing: Contact CDSCO-approved labs early to avoid delays.
6. Prepare for Audit: Align your Quality Management System and manufacturing processes with notified body expectations.
7. Submit Manufacturing License Application: Once testing and documentation are complete, file Form MD3.

By following this structured approach, you can efficiently secure your MD5 license and bring your Endothermic Cold Therapy Pack to the Indian market with confidence.

For personalized assistance, reach out to our expert consultants who specialize in CDSCO licensing for pain management devices like yours. Let us help you turn regulatory complexity into your competitive advantage.