CDSCO License for Hand dynamometer/pinch meter, mechanical

Comprehensive Guide to CDSCO Licensing for Hand Dynamometer (Mechanical) - Class A Medical Device

As seasoned regulatory consultants with over 25 years of experience and a proven track record of assisting 500+ companies in securing CDSCO licenses, we understand the nuances involved in navigating India's medical device regulations. This guide specifically addresses the CDSCO licensing process for the Hand Dynamometer (Mechanical), a Class A rehabilitation device designed to assess neuromuscular function by measuring hand and forearm muscle strength.

Understanding the Hand Dynamometer and Its Regulatory Importance

The Hand Dynamometer, also known as a pinch meter, is a mechanical device widely used in rehabilitation settings to evaluate muscle force exertion. Given its direct impact on health assessments, obtaining the correct regulatory approval from the Central Drugs Standard Control Organization (CDSCO) is crucial for legal manufacture and marketing in India. The device falls under Class A (low risk) as per the CDSCO classification system and is notified under File No. 29/Misc./03/2020-DC (160) dated 04.08.2022.

CDSCO Regulatory Framework for Hand Dynamometer (Mechanical)

The CDSCO classifies medical devices into four risk-based categories—Class A, B, C, and D—based on their intended use and potential risk to patients. The Hand Dynamometer, being a mechanical rehabilitation device with low risk, is categorized as Class A. This classification governs the licensing requirements, authorities involved, and the documentation needed.

Risk Classification and License Requirements for Class A Devices

• Risk Class: A (Low Risk)
• License Type: MD5 Manufacturing License
• Issuing Authority: State Licensing Authority

Manufacturers of Class A devices must secure an MD5 license through the State Authority. This involves a multi-step compliance process including obtaining a test license, product testing, document submission, and an audit by a notified body.

Manufacturing License Process for Hand Dynamometer (MD5 License)

The MD5 license procedure typically spans 3-4 months and involves the following key steps:

1. Test License Application (Form MD13): Submit an application to obtain a test license, which permits limited manufacturing for testing purposes. This usually takes 1.5 to 2 months.

2. Product Testing: Conduct product testing at government-recognized laboratories to validate safety and performance. Refer to the list of approved Testing Laboratories to select an authorized facility.

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

4. License Application Submission (Form MD3): File the manufacturing license application for MD5 on the CDSCO MD Online Portal.

5. Audit by Notified Body: Undergo an on-site audit by a notified body listed on the Notified Bodies List for MD5 Audit to verify compliance with manufacturing practices.

6. Query Resolution: Address any observations or queries raised by the notified body or state authority promptly.

7. Grant of MD5 License: Upon successful audit and document approval, the MD5 license is issued, authorizing commercial manufacturing.

Manufacturing License Documents Required

For a Hand Dynamometer (Class A) MD5 license, the following documents must be meticulously prepared and submitted:

• Company Constitution/Registration Certificate
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualification Certificates of Technical Staff
• Fire NOC and Pollution Control NOC
• Device Master File (DMF) detailing device specifications and design
• Plant Master File (PMF) documenting manufacturing facilities and processes
• Essential Principles Checklist confirming conformity with regulatory standards
• Risk Management File demonstrating hazard identification and mitigation (see our Risk Management guide)
• Test Reports from government-approved testing labs
• Product Labels and Instructions For Use (IFU)
• Quality Management System (QMS) Documents, typically ISO 13485 compliant

Practical Tip: Early preparation of DMF and PMF is critical; we recommend consulting our Device Master File guide and Plant Master File guide to streamline documentation.

Import License Process for Hand Dynamometer (MD15 License)

If you are an importer aiming to bring the Hand Dynamometer into India, you must obtain an MD15 import license from the Central Licensing Authority. The steps include:

• Preparing comprehensive documentation (including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE certification, DMF, PMF, wholesale license, and company constitution).
• Submitting an application on the CDSCO MD Online Portal using Form MD14.
• Resolving any queries raised by the CDSCO department.
• Awaiting license grant, typically within 5-6 months.

Import License Documents Required

• Valid Manufacturing License from country of origin
• Free Sale Certificate issued by the regulatory authority
• ISO 13485:2016 certification
• CE Certificate or equivalent
• Device Master File
• Plant Master File
• Wholesale License
• Company Constitution and related documents

Timeline and Processing Duration

Government Fees and Costs

• MD5 License Application Fee: Rs 5,000 per application
• Product Fees: Rs 500 per product
• Testing Costs: Varies based on laboratory and number of tests; typically Rs 30,000 – Rs 50,000
• Audit Fees: Paid directly to the notified body, varies

Budgeting effectively for these expenses upfront avoids last-minute surprises.

Common Challenges and Practical Solutions

• Delayed Test Reports: Select accredited, experienced laboratories with proven turnaround times.
• Incomplete Documentation: Use comprehensive checklists and templates; leverage expert consultants.
• Audit Non-compliance: Conduct internal mock audits and ensure QMS adherence before the notified body visit.
• Query Resolution Delays: Respond promptly and comprehensively to queries; maintain clear communication with authorities.

Expert Consultation and Support

Navigating the CDSCO licensing landscape can be complex, especially for first-time manufacturers or importers of Class A devices like the Hand Dynamometer. Our deep expertise allows us to:

• Prepare and review all regulatory documents for accuracy and compliance
• Guide you through the test license and product testing stages
• Liaise with notified bodies and regulatory authorities to expedite audits and approvals
• Provide tailored risk management and QMS implementation support

Partnering with experienced consultants minimizes risks and accelerates your time to market.

Getting Started with Your CDSCO License Application for Hand Dynamometer

1. Assess your device classification and ensure it matches Class A criteria.
2. Register on the CDSCO MD Online Portal to initiate your application.
3. Begin documentation preparation early, focusing on DMF, PMF, and Risk Management Files.
4. Apply for the MD13 test license to begin product testing legally.
5. Engage a notified body well in advance to schedule your audit post-testing.
6. Prepare for audit by conducting internal reviews and ensuring facility compliance.
7. Submit your MD5 license application (Form MD3) once testing and audit are complete.
8. Respond promptly to any queries to avoid delays.

By following these actionable steps and leveraging expert guidance, manufacturers and importers can successfully obtain CDSCO licenses for the Hand Dynamometer and confidently enter the Indian rehabilitation device market.

For a detailed walkthrough of the MD5 licensing process, please visit our MD5 License Guide.

We are here to support your journey towards regulatory compliance and market success.