CDSCO License for Hand dynamometer/pinch meter, electronic

Comprehensive CDSCO Licensing Guide for Electronic Hand Dynamometer (Pinch Meter)

Electronic hand dynamometers, also known as pinch meters, are vital rehabilitation devices used to assess neuromuscular function by measuring the force or power exerted by hand and forearm muscles. Given their critical role in diagnostics and therapy, these devices fall under Class B risk category as per CDSCO regulations. Navigating the CDSCO licensing process can be challenging, but with over 25 years of regulatory consulting experience assisting 500+ companies, we’ve distilled everything you need to confidently obtain your MD5 manufacturing license.

CDSCO Regulatory Framework for Electronic Hand Dynamometer

The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India. For your device, classified as Class B, the State Licensing Authority issues the manufacturing license under the MD5 category. The process is designed to ensure that your electronic hand dynamometer meets all safety, quality, and efficacy standards before entering the Indian market.

Risk Classification and License Requirements for Class B Devices

Hand dynamometers are classified under Class B due to moderate risk associated with their diagnostic function impacting patient outcomes. This classification triggers the requirement for an MD5 license (application via Form MD3) issued by the State Licensing Authority. The complete process includes:

• Obtaining a Test License (Form MD13)
• Product testing at government-approved labs
• Documentation compilation
• Application submission and audit by a notified body
• Resolution of queries
• Final license grant (Form MD5)

For more details on classification, visit our Medical Device Classification guide.

Step-by-Step Manufacturing License Process (MD5) for Electronic Hand Dynamometer

1. Apply for Test License (Form MD13): This initial step takes approximately 1.5 to 2 months. The test license permits you to conduct product testing and evaluation.

2. Product Testing: Mandatory testing must be carried out in CDSCO-recognized laboratories to validate device performance and safety. Refer to the list of testing laboratories for approved centers.

3. Documentation Preparation: Comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist must be developed. Our detailed Device Master File guide helps you prepare precise and compliant files.

4. Submit Application for MD5 License (Form MD3): After successful testing and documentation, submit your application via the CDSCO MD Online Portal.

5. Audit by Notified Body: An audit by a notified body listed here is conducted to verify compliance with quality systems and manufacturing capabilities.

6. Address Queries: You may receive queries from CDSCO or the notified body; promptly addressing them expedites approval.

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

Essential Documents Required for MD5 License Application

• Company Constitution: Incorporation certificate, Memorandum & Articles of Association
• Proof of Premises Ownership: Rent agreement or sale deed
• Technical Staff Details: Qualification and experience certificates
• Fire NOC & Pollution Control NOC: From local authorities
• Device Master File: Complete device description, design, manufacturing process
• Plant Master File: Details of manufacturing facilities and quality systems (refer to our Plant Master File guide)
• Essential Principles Checklist: Compliance matrix for safety and performance
• Risk Management File: Hazard analysis and mitigation strategies (see Risk Management guide)
• Test Reports: From CDSCO-approved testing laboratories
• Labels and Instructions for Use (IFU): Accurate and compliant labeling and user manual
• Quality Management System Documents: ISO 13485 certification and related SOPs

Import License Process (MD15) for Electronic Hand Dynamometer

For importers, the MD15 license issued by the Central Licensing Authority is mandatory. The process takes approximately 5-6 months and requires:

• Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 and CE Certificate
• Device and Plant Master Files
• Wholesale License
• Company Constitution

The application is submitted on the CDSCO MD Online Portal. For detailed guidance, check our Import License guide.

Timeline and Processing Duration

Total Estimated Time: Approximately 3 to 4 months.

Government Fees and Costs

• Application fee: ₹5,000 per application
• Product fee: ₹500 per product
• Testing and audit costs vary depending on notified body and testing lab fees.

For a hand dynamometer, budgeting around ₹1,00,000 - ₹1,50,000 inclusive of all fees and testing is prudent.

Common Challenges and Practical Solutions

• Delayed Testing Results: Schedule tests early and select labs with proven turnaround times.
• Incomplete Documentation: Use checklists and expert reviews to ensure all files comply with CDSCO standards.
• Audit Non-compliance: Pre-audit your facilities and processes using experienced consultants.
• Query Backlogs: Maintain prompt and clear communication with authorities.

Expert Consultation and Support

With over 25 years in the field and a track record of assisting 500+ companies, we provide end-to-end support including:

• Pre-application gap analysis
• Device and Plant Master File preparation
• Risk management implementation
• Test license and product testing coordination
• Liaison with notified bodies and CDSCO inspectors

Our personalized consultation ensures your electronic hand dynamometer license is granted efficiently.

Getting Started with Your CDSCO License Application

1. Begin by registering on the CDSCO MD Online Portal and familiarize yourself with the submission process.
2. Conduct initial device classification verification and prepare your Device Master File.
3. Apply for your Test License (Form MD13) while simultaneously coordinating with an approved testing laboratory.
4. Assemble your technical and quality documentation in parallel to testing.
5. Engage with a notified body early to schedule your audit to avoid delays.

By following these steps and leveraging expert support, your journey toward CDSCO MD5 licensing for your electronic hand dynamometer can be streamlined and successful. Feel free to reach out for a tailored consultation to kickstart your regulatory compliance process today.