CDSCO License for Back/leg/chest dynamometer, electronic

Comprehensive Guide to CDSCO Licensing for Electronic Back/Leg/Chest Dynamometer (Risk Class B)

As a seasoned regulatory consultancy with over 25 years of experience successfully assisting 500+ medical device companies in India, we understand the critical importance of obtaining the right CDSCO license for your medical devices. This detailed guide focuses on the electronic back/leg/chest dynamometer, a Class B powered rehabilitation device designed to measure muscle force and power during flexion.

Understanding the Device and Regulatory Importance

The electronic back/leg/chest dynamometer serves an essential role in rehabilitation by providing objective neuromuscular assessment, aiding clinicians in patient diagnosis and therapy planning. Given its direct impact on patient health and safety, it falls under Risk Class B per CDSCO classification, requiring a stringent regulatory pathway to ensure compliance, safety, and performance.

The device is notified under File No. 29/Misc./03/2020-DC (160) dated 04.08.2022, confirming its categorization and regulatory requirements under CDSCO.

CDSCO Regulatory Framework for Electronic Back/Leg/Chest Dynamometer

In India, medical devices are regulated by the Central Drugs Standard Control Organisation (CDSCO). For Class B devices like yours, the MD5 manufacturing license is mandatory and is issued by the State Licensing Authority. This license ensures that manufacturing practices, quality systems, and product testing meet the required standards.

Importers must secure an MD15 import license from the Central Licensing Authority if importing this device.

Risk Classification and License Requirements

• Device Risk Class: B (Low Moderate Risk)
• Regulatory License Needed: MD5 Manufacturing License (Form MD3)
• Authority: State Licensing Authority
• Additional Requirements: Test License (Form MD13), product testing from CDSCO-approved labs, audit by notified bodies

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

Manufacturing License Process (MD5) for Class B Devices

The MD5 license process for your electronic dynamometer typically takes 3 to 4 months and involves several critical steps:

1. Test License (Form MD13): Apply for a test license to manufacture the device for testing purposes. This initial step takes approximately 1.5 to 2 months.

2. Product Testing: Get your device tested at CDSCO-recognized laboratories. Testing ensures conformity with Indian standards and safety requirements. Find approved labs on the CDSCO Testing Laboratories list.

3. Document Preparation: Prepare comprehensive documents including Device Master File, Plant Master File, Risk Management File, and QMS documents.

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

5. Audit by Notified Body: Undergo an audit by a notified body listed here. The audit evaluates your manufacturing facility and quality systems.

6. Resolution of Queries: Address any observations or queries raised by CDSCO or the notified body.

7. Grant of License (Form MD5): Upon satisfactory compliance, the State Licensing Authority issues the MD5 manufacturing license.

For an in-depth walkthrough, see our MD5 License Guide.

Manufacturing License Documents Required

To streamline your application, ensure you have the following documents ready:

• Company Constitution/Registration Certificate
• Proof of Ownership or Lease of Manufacturing Premises
• Details and qualifications of Technical Staff
• Fire NOC and Pollution Control NOC
• Device Master File (DMF) detailing device design, specifications, and manufacturing process (Device Master File Guide)
• Plant Master File (PMF) describing manufacturing infrastructure and quality systems (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with applicable standards
• Risk Management File documenting hazard analysis and risk mitigation (Risk Management Guide)
• Test Reports from CDSCO-approved laboratories
• Device labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents, preferably ISO 13485 certified

Import License Process (MD15) for Electronic Dynamometers

If you plan to import the electronic dynamometer into India, an MD15 import license from CDSCO Central Licensing Authority is required. The process generally takes 5 to 6 months and involves:

• Document preparation including your manufacturing license, Free Sale Certificate, ISO 13485:2016 certificate, CE certificate, Device and Plant Master Files
• Submission of application on the CDSCO MD Online Portal
• Resolution of queries raised by CDSCO
• Grant of MD15 license (Form MD15)

Refer to our Import License Guide for detailed assistance.

Import License Documents Required

• Valid Manufacturing License from country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale License for distribution in India
• Company Constitution and Registration

Timeline and Processing Duration Summary

Government Fees and Costs

For your Class B device, the fees for manufacturing and import licenses are as follows:

• MD5 Manufacturing License:

  • Application Fee: Rs. 5,000
  • Per Product Fee: Rs. 500

• MD15 Import License:

  • Site Fee: USD 2,000
  • Per Product Fee: USD 1,000

These fees are payable online via the CDSCO portal during application submission.

Common Challenges and Practical Solutions

Challenge: Delay in obtaining test reports from approved labs.

Solution: Engage labs early and opt for government-approved laboratories listed on the CDSCO Testing Laboratories page. Ensure your samples meet testing requirements to avoid retesting.

Challenge: Incomplete documentation leading to application rejection.

Solution: Rely on comprehensive document checklists and expert reviews. Utilize our Device Master File and Plant Master File guides to prepare robust submissions.

Challenge: Audit non-compliance issues.

Solution: Pre-audit your facility using notified body standards and ensure your QMS and risk management processes are fully implemented.

Expert Consultation and Support

Navigating CDSCO licensing can be complex, but with our 25+ years of expertise, we have successfully guided over 500 manufacturers and importers through these processes. Our services include:

• Gap analysis and documentation support
• Coordination with notified bodies and testing laboratories
• Application submission and query handling
• Training on risk management and regulatory compliance

Contact us to leverage our proven track record for your electronic dynamometer licensing needs.

Getting Started with Your CDSCO License Application

1. Assess your device classification and confirm your licensing path (MD5 for manufacturing, MD15 for import).

2. Register your company on the CDSCO MD Online Portal to initiate your application.

3. Apply for the Test License (MD13) to legally produce samples for testing.

4. Arrange for product testing at an approved laboratory.

5. Prepare and compile all required documents, paying special attention to Device Master File, Plant Master File, and Risk Management File.

6. Schedule your notified body audit early to avoid delays.

7. Submit your manufacturing license application (Form MD3) on the CDSCO portal.

8. Respond promptly to any CDSCO queries to expedite approval.

Starting early and maintaining clear communication with authorities and notified bodies is key to a smooth licensing process. For personalized assistance, reach out to our regulatory experts who will guide you through every step.

Embark on your CDSCO licensing journey confidently with our expert support and ensure your electronic back/leg/chest dynamometer reaches the Indian rehabilitation market compliantly and efficiently.