CDSCO License for Acupressure wristband

Introduction to Acupressure Wristband and Its Regulatory Importance

The Acupressure Wristband is an innovative medical device designed for pain management, specifically to alleviate nausea by applying pressure to the Nei-kuan (P6) acupressure point on the wrist. Given its intended medical purpose, this device falls under the regulatory purview of the Central Drugs Standard Control Organisation (CDSCO) in India. Securing the appropriate CDSCO license is crucial for manufacturers aiming to market the Acupressure Wristband in India, ensuring compliance with safety, efficacy, and quality standards.

With over 25 years of experience and having assisted 500+ companies, we understand the nuances of obtaining CDSCO licenses, especially for Class A medical devices like the Acupressure Wristband. This comprehensive guide walks you through the entire regulatory framework, license application process, timelines, costs, challenges, and practical tips.

CDSCO Regulatory Framework for Acupressure Wristbands

The Acupressure Wristband is categorized under the Pain Management category and is classified as a Class A medical device according to CDSCO’s risk-based classification system. This classification mandates a specific regulatory pathway focused on ensuring minimal risk to patients while maintaining high standards for manufacturing and distribution.

The device is governed under the Medical Device Rules (MDR) 2017, amended periodically, with the latest notification being File No. 29/Misc./03/2020-DC (178) dated 13.9.2021. Compliance with these rules is mandatory for market access.

Risk Classification and License Requirements for Acupressure Wristbands

As a Class A device, the Acupressure Wristband requires an MD5 manufacturing license, granted by the State Licensing Authority. This is the entry-level risk classification, typically involving a streamlined yet thorough approval process.

The MD5 license process involves multiple steps, including obtaining a test license (MD13), conducting product testing at government-approved laboratories, preparing comprehensive documentation, and undergoing an audit by a notified body.

Manufacturing License Process (MD5) for Acupressure Wristbands

1. Test License (Form MD13): Initiate the process by applying for a test license that allows manufacturing of the device for testing purposes. This stage typically takes 1.5 to 2 months.

2. Product Testing: Get the Acupressure Wristband tested at government-approved laboratories to verify compliance with safety and performance standards.

3. Documentation Preparation: Compile essential documents, including the Device Master File and Plant Master File, technical specifications, labeling, Instructions for Use (IFU), and Quality Management System (QMS) documents.

4. License Application (Form MD3): Submit the manufacturing license application for the MD5 license through the CDSCO MD Online Portal.

5. Audit by Notified Body: A notified body conducts a thorough audit of your manufacturing facility and documentation. You can find the list of notified bodies here.

6. Query Resolution: Address any queries raised by the CDSCO or notified body promptly to avoid delays.

7. License Grant (Form MD5): Upon successful completion of all steps, the State Licensing Authority grants the MD5 manufacturing license.

Manufacturing License Documents Required for Acupressure Wristbands

• Company Constitution (Partnership deed, Memorandum & Articles of Association)
• Proof of ownership or lease of manufacturing premises
• Qualification and experience certificates of technical staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF): Detailed technical specifications and design (Device Master File guide)
• Plant Master File (PMF): Details of manufacturing premises and processes (Plant Master File guide)
• Essential Principles Compliance Checklist
• Risk Management File (Risk Management resource)
• Test Reports from government-approved testing laboratories (Testing Laboratories list)
• Product Labels and Instructions for Use (IFU)
• Quality Management System documentation (ISO 13485:2016 compliance recommended)

Import License Process (MD15) for Acupressure Wristbands

For importers intending to bring the Acupressure Wristband into India, an MD15 import license issued by the Central Licensing Authority is mandatory. The process differs slightly from manufacturing licenses:

• No test license is required.
• Prepare all relevant documents including manufacturing license from the country of origin, Free Sale Certificate, CE Certificate, Device and Plant Master Files, Wholesale License, and ISO 13485 certificate.
• Submit application on the CDSCO MD Online Portal using Form MD14.
• Address any queries raised by CDSCO.
• The process typically takes 5-6 months.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 certification
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale License (if applicable)
• Company Constitution documents

Timeline and Processing Duration

For import licenses (MD15), expect 5 to 6 months from application to license grant.

Government Fees and Costs

• MD5 Manufacturing License: Rs. 5,000 per application + Rs. 500 per product
• Test License (MD13): Fees vary by state but generally included in the MD5 process

For import licenses (MD15), fees vary by risk class but for Class A devices like the Acupressure Wristband, expect approximately $1,000 per site and$50 per product.

Common Challenges and Solutions

• Incomplete Documentation: Many applicants face delays due to missing or incomplete documents. We recommend meticulous preparation of Device and Plant Master Files early in the process.
• Delays in Product Testing: Coordinate with government-approved laboratories well in advance. Refer to the official Testing Laboratories list for reliable options.
• Audit Non-Compliance: Pre-audit readiness checks can prevent major findings. Engage experienced consultants to assist with compliance.
• Query Management: Respond promptly and comprehensively to queries from CDSCO or notified bodies to avoid procedural delays.

Expert Consultation and Support

Navigating the CDSCO licensing process for Class A devices like the Acupressure Wristband demands expertise and precision. Our team, with over 25 years of regulatory experience, provides end-to-end support—from documentation preparation to audit facilitation and query resolution.

We customize guidance based on your specific manufacturing setup and product profile, ensuring you meet all regulatory expectations smoothly.

Getting Started with Your CDSCO License Application

1. Assess your Device Classification: Confirm Class A status using resources like our Medical Device Classification guide.

2. Prepare Essential Documentation: Begin compiling your Device Master File, Plant Master File, and Risk Management File immediately.

3. Apply for Test License (MD13): Submit your application through the CDSCO MD Online Portal.

4. Schedule Product Testing: Engage with notified testing laboratories early to avoid bottlenecks.

5. Engage a Notified Body: Select from the official list of notified bodies for your audit.

6. Submit Manufacturing License Application (Form MD3): Once testing and documentation are complete.

7. Prepare for Audit and Queries: Ensure your facility meets all regulatory requirements and respond swiftly to any queries.

By following these steps and leveraging our expertise, you can smoothly navigate the regulatory landscape and bring your Acupressure Wristband to the Indian market. Contact us today to initiate your CDSCO licensing journey with confidence.