CDSCO License for Chemical cold pack snakebite kit.

Comprehensive Guide to CDSCO Licensing for Chemical Cold Pack Snakebite Kits (Class D)

Chemical cold pack snakebite kits are critical first-aid devices designed to provide immediate treatment following snakebites. Classified under Class D—the highest risk category under Indian regulations—these kits fall into the General Hospital or Orthopaedic Instruments category as per Notification 29/Misc./03/2020-DC (193)- Part-3, dated 16.03.2022. Given their life-saving purpose and high-risk classification, obtaining proper CDSCO licensing is mandatory before manufacturing or importing in India.

With over 25 years of experience and having assisted more than 500 companies navigate the CDSCO regulatory landscape, we provide a detailed, practical roadmap to help you efficiently secure your license.

CDSCO Regulatory Framework for Chemical Cold Pack Snakebite Kits

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules, 2017. As a Class D device, chemical cold pack snakebite kits require rigorous scrutiny to ensure safety, efficacy, and quality.

The device is regulated by the Central Licensing Authority (CLA) due to its high-risk classification. The governing notification places it under the General Hospital or Orthopaedic Instruments category, necessitating compliance with advanced regulatory standards.

Understanding this framework is crucial to streamline your licensing application and avoid common pitfalls.

Risk Classification and License Requirements

The Chemical Cold Pack Snakebite Kit is classified as a Class D medical device. Class D devices present the highest risk to patients and users, and thus, their licensing process is more stringent.

License Type: MD9 Manufacturing License (Application Form MD7)

Authority: Central Licensing Authority (CLA)

Process Highlights:

• Initial Test License on Form MD13
• Product testing at CDSCO-approved laboratories
• Comprehensive documentation and audit
• Final grant of MD9 license

For detailed classification criteria, refer to our Medical Device Classification guide.

Manufacturing License Process (MD9)

1. Apply for Test License (Form MD13): Before initiating full-scale manufacturing, obtain a test license which allows you to produce the device for testing purposes. This phase usually takes about 1.5 to 2 months.

2. Product Testing: Submit your chemical cold pack kits to CDSCO-approved testing laboratories to validate compliance with applicable standards. Testing duration varies but generally completes within 4-6 weeks. View the list of approved testing laboratories.

3. Document Preparation: Compile required documents including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and Quality Management System (QMS) documentation.

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

5. CDSCO Audit: After preliminary review, CDSCO inspectors conduct an audit of your manufacturing facility and quality systems.

6. Query Resolution: Respond promptly and comprehensively to any queries raised during the audit or document review.

7. License Grant: Upon successful compliance, the MD9 manufacturing license is granted.

For a step-by-step walkthrough, consult our detailed MD9 License guide.

Manufacturing License Documents Required

For Class D devices like the chemical cold pack snakebite kit, the documentation requirements are stringent. The key documents include:

• Company Constitution Documents: Certificate of Incorporation, Memorandum and Articles of Association
• Proof of Premises Ownership/Lease Agreement
• Technical Staff Details: Qualifications and experience of Responsible Technical Officer (RTO) and key personnel
• Fire and Pollution NOCs: Obtain clearances from local authorities
• Device Master File (DMF): Detailed product design, specifications, and manufacturing process (Guide to DMF)
• Plant Master File (PMF): Overview of your manufacturing facility and quality control systems (PMF Guide)
• Essential Principles Checklist: Compliance checklist per Medical Device Rules
• Risk Management File: Documentation of risk analysis and mitigation measures (Risk Management Reference)
• Test Reports: From CDSCO-approved labs
• Product Labels and Instructions for Use (IFU): Compliant with Indian regulations
• Quality Management System Documents: ISO 13485:2016 certification and internal procedures

Preparing these documents meticulously can significantly reduce back-and-forth queries.

Import License Process (MD15)

If you are an importer of chemical cold pack snakebite kits, the import license is issued as an MD15 license by the Central Licensing Authority.

Key steps include:

1. Document Preparation: Gather mandatory documents such as manufacturing license of the overseas manufacturer, Free Sale Certificate, ISO 13485:2016 certification, CE certificate, and your company constitution.

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

3. Query Resolution: Engage promptly with CDSCO for any clarifications.

4. License Issuance: Once cleared, receive your MD15 import license.

Refer to our dedicated Import License guide for detailed insights.

Import License Documents Required

• Valid Manufacturing License of Foreign Manufacturer
• Free Sale Certificate from Country of Origin
• ISO 13485:2016 Certification
• CE Marking Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale Drug License (if applicable)
• Company Constitution Documents

Ensuring all documents are current and translated into English can expedite processing.

Timeline and Processing Duration

Overall, expect approximately 5 to 7 months from initiation to full manufacturing license grant for Class D devices.

Government Fees and Costs

For your chemical cold pack snakebite kit as a Class D device, the fees structure is as follows:

• MD13 Test License: Approximately Rs 50,000
• MD9 Manufacturing License:
  • Application Fee: Rs 50,000
  • Per Product Fee: Rs 1,000
• MD15 Import License:
  • Site Fee: $3,000 (approx Rs 2.5 lakh)
  • Per Product Fee: $1,500 (approx Rs 1.25 lakh)

Additional costs include testing fees, audit fees charged by notified bodies, and consultancy fees if applicable.

Common Challenges and Solutions

• Delayed Testing: Testing laboratories often have backlogs. Proactively schedule and confirm testing slots early.

• Incomplete Documentation: Missing or inconsistent documents are a major cause of delays. Use detailed checklists and expert reviews.

• Audit Non-Compliance: Prepare your facility and QMS thoroughly before the audit. Conduct mock audits to identify gaps.

• Query Management: Respond comprehensively and within stipulated timelines to CDSCO queries to avoid application rejection.

• Understanding Regulatory Updates: Keep abreast of notifications and amendments. The recent notification dated 16.03.2022 impacts classification and requirements.

Expert Consultation and Support

Navigating the CDSCO licensing process for high-risk devices like chemical cold pack snakebite kits demands specialized knowledge and experience. Our team has successfully supported over 500 manufacturers and importers across India, offering:

• Detailed gap analysis and documentation support
• End-to-end application management on the CDSCO MD Online Portal
• Coordination with notified bodies and testing labs
• Audit preparation and post-audit support
• Regulatory updates and compliance advisory

Partnering with experts significantly reduces approval timelines and ensures compliance.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your device falls under Class D as per CDSCO notifications.

2. Initiate Test License Application: Prepare and submit Form MD13 on the CDSCO portal.

3. Engage Testing Laboratories: Schedule product testing early to avoid delays.

4. Prepare Comprehensive Documentation: Utilize our Device Master File and Plant Master File guides.

5. Submit Manufacturing License Application (MD9): File Form MD7 once testing is complete.

6. Prepare for CDSCO Audit: Conduct internal audits and training.

7. Respond to Queries Promptly: Maintain open communication with CDSCO.

By following these practical steps and leveraging our expert insights, you can confidently navigate the complex CDSCO licensing pathway for your chemical cold pack snakebite kit, accelerating your entry into the Indian medical device market.

For personalized assistance, contact us today and ensure your licensing journey is smooth and successful.