CDSCO License for Ice collar

Introduction to Ice Collar Device and Regulatory Importance

The ice collar is a Class A medical device designed primarily for pain management, intended to alleviate pain and promote healing in minor injuries affecting the neck, throat, and head, as well as to soothe sore throats. Given its therapeutic purpose, it falls under the purview of the Central Drugs Standard Control Organization (CDSCO) in India. Navigating the CDSCO regulatory landscape is critical for manufacturers and importers aiming to launch this device in the Indian market, ensuring compliance with safety and quality standards.

With over 25 years of experience in assisting 500+ companies with CDSCO licensing, we understand the nuances involved in obtaining the MD5 manufacturing license for Class A devices like the ice collar. This guide offers a detailed roadmap covering every aspect — from risk classification and documentation to timelines, fees, and practical challenges.

CDSCO Regulatory Framework for Ice Collar (Class A Medical Device)

The CDSCO regulates medical devices under the Medical Device Rules (MDR) 2017, categorizing devices based on risk. The ice collar, notified under File No. 29/Misc./03/2020-DC (178) dated 13.9.2021, is classified as a Class A device due to its low risk profile.

Class A devices require a manufacturing license (MD5) issued by the State Licensing Authority. The process involves obtaining a test license first, followed by product testing, documentation, audit by a notified body, and eventual license grant.

Risk Classification and License Requirements for Ice Collar

• Risk Class: A (Low Risk)
• License Type: MD5 Manufacturing License
• Authority: State Licensing Authority
• Application Form: MD3 for manufacturing license, MD13 for test license
• Typical Timeline: 3-4 months total
• Fees: Rs 5,000 per application + Rs 500 per product

This classification mandates adherence to general safety and performance requirements, including conformity to essential principles and quality management systems.

Manufacturing License Process (MD5) for Ice Collar

1. Test License Application (Form MD13): Initiate with an application for a test license, which allows manufacturing of the ice collar for testing purposes. This process usually takes 1.5 to 2 months.

2. Product Testing: Conduct mandatory testing of the ice collar in CDSCO-approved laboratories. Testing parameters typically include biocompatibility, performance, and safety standards relevant to pain management devices.

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

4. License Application (Form MD3): Submit the manufacturing license application through the CDSCO MD Online Portal.

5. Audit by Notified Body: Coordinate with a notified body for an on-site audit of manufacturing premises and QMS compliance. Refer to the list of notified bodies for selection.

6. Queries and Clarifications: Respond promptly to any queries raised by the regulatory authority or notified body during the review.

7. License Grant: Upon satisfactory compliance, the State Licensing Authority issues the MD5 license on Form MD5.

Manufacturing License Documents Required for Ice Collar

For a smooth application process, prepare the following documents meticulously:

• Company Constitution (e.g., MOA, AOA)
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (Detailed device specifications and design) – see our comprehensive Device Master File guide
• Plant Master File (Manufacturing processes and infrastructure) – learn more on creating a Plant Master File
• Essential Principles Checklist demonstrating conformity
• Risk Management File reflecting hazard analysis and mitigation strategies – explore Risk Management
• Product Test Reports from CDSCO-approved labs (Testing Laboratories)
• Labels and Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485 certification recommended)

Import License Process (MD15) for Ice Collar

If you plan to import the ice collar into India rather than manufacture locally, you must obtain an MD15 import license from the Central Licensing Authority.

Key Steps Include:

• Preparation of required documents including existing manufacturing licenses, Free Sale Certificates, ISO 13485, CE certificates, Device and Plant Master Files, and Wholesale License.
• Application submission via the CDSCO MD Online Portal.
• Resolution of queries raised by CDSCO.
• License grant typically within 5-6 months.

For detailed guidance, refer to our Import License guide.

Import License Documents Required for Ice Collar

• Valid Manufacturing License of the device from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale License for distribution in India
• Company Constitution

Timeline and Processing Duration

Manufacturers should initiate the test license process early to accommodate lab testing timelines and document finalization.

Government Fees and Costs

• Test License (MD13): No separate fee; included in overall process.
• MD5 Manufacturing License Application Fee: Rs 5,000 per application
• Additional Fee: Rs 500 per product (applicable if multiple variants of the ice collar exist)

Additional costs may include notified body audit fees, product testing charges, and consultancy expenses if external support is engaged.

Common Challenges and Solutions

Challenge: Delays in product testing due to backlog at government-approved labs.

Solution: Schedule testing well in advance and consider third-party labs approved by CDSCO to expedite results.

Challenge: Incomplete or inadequate documentation leading to query cycles.

Solution: Engage experienced regulatory consultants to prepare and review documents, ensuring alignment with CDSCO expectations.

Challenge: Audit non-compliance due to gaps in QMS or facility standards.

Solution: Conduct pre-audit internal reviews and gap analyses using notified body checklists.

Expert Consultation and Support

Our team, with over 25 years of expertise and a track record of facilitating over 500 successful CDSCO licenses, offers end-to-end support including:

• Gap analysis and document preparation
• Coordination with notified bodies and testing laboratories
• Application submission and query management
• Training on regulatory compliance and QMS implementation

We tailor our services to your unique needs, ensuring a hassle-free licensing journey.

Getting Started with Your CDSCO License Application for Ice Collar

1. Assessment: Confirm your device classification as Class A under the notified file number.

2. Documentation: Begin compiling your Device Master File, Plant Master File, risk management documentation, and QMS manuals.

3. Test License Application: Submit Form MD13 through the CDSCO MD Online Portal to commence the test license process.

4. Testing Coordination: Arrange testing at CDSCO-approved laboratories.

5. Audit Scheduling: Identify and engage a notified body early to schedule your manufacturing site audit.

6. Final Submission: After test results and audit clearance, submit Form MD3 for the MD5 license.

Taking these focused steps will accelerate your path to market entry with a compliant ice collar device in India. Reach out to our expert consultants to ensure a seamless and efficient regulatory approval process.