CDSCO License for Torque Wrench

Comprehensive Guide to CDSCO Licensing for Torque Wrench (Class A Medical Device)

As a trusted regulatory consultancy with over 25 years of experience and having supported 500+ medical device companies, we understand the challenges manufacturers and importers face in navigating India's regulatory landscape. This guide specifically addresses CDSCO licensing for the Torque Wrench—a Class A medical device used for tightening setscrews on implantable pulse generator connectors, categorized under General Hospital or Orthopaedic Instruments as per the CDSCO Notification 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022.

Understanding the Regulatory Importance of Torque Wrench Licensing

Torque wrenches, though classified as low-risk Class A devices, are critical tools in orthopedic and implantable device procedures. Ensuring compliance with CDSCO regulations not only guarantees patient safety but also facilitates smooth market entry and uninterrupted business operations in India.

CDSCO Regulatory Framework for Class A Medical Devices like Torque Wrench

The Central Drugs Standard Control Organization (CDSCO) governs the approval and licensing of medical devices in India. The regulatory framework requires manufacturers of Class A devices to obtain a Manufacturing License (MD5) from the State Licensing Authority. The process incorporates product testing, documentation, and audits to verify compliance with Indian Medical Device Rules (IMDR) 2017.

Risk Classification and License Requirements for Torque Wrench

Torque Wrench falls under Class A (low risk) according to the CDSCO classification Medical Device Classification. This designation mandates the following:

• Manufacturing License: MD5 License (Form MD3) issued by State Licensing Authority
• Testing: Mandatory product testing from government-approved labs
• Documentation: Comprehensive technical and quality documentation

Manufacturing License Process (MD5) for Torque Wrench

Obtaining an MD5 license involves multiple stages:

1. Test License Application (Form MD13): Apply for a test license to legally manufacture the Torque Wrench for testing purposes. This typically takes 1.5 to 2 months.
2. Product Testing: Submit samples to CDSCO-approved testing laboratories for evaluation. Refer to the Testing Laboratories List for approved labs.
3. Documentation Preparation: Compile all required documents including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documentation.
4. License Application (Form MD3): Submit the manufacturing license application via the CDSCO MD Online Portal once testing and documentation are complete.
5. Audit by Notified Body: Engage a notified body for a compliance audit. Review the Notified Bodies List to select an authorized auditor.
6. Query Resolution: Respond to any queries raised by CDSCO or the notified body promptly.
7. License Grant: Upon satisfactory compliance, the State Licensing Authority issues the MD5 license.

Manufacturing License Documents Required for Torque Wrench

The documentation package must be thorough and accurate. Key documents include:

• Company Constitution and Incorporation Certificates
• Proof of Premises Ownership or Lease Agreement
• Technical Staff Qualification and Experience Details
• Fire NOC and Pollution Control NOC
• Device Master File (DMF): Detailed device design and manufacturing info (Device Master File Guide)
• Plant Master File (PMF): Facility and quality control processes (Plant Master File Guide)
• Essential Principles Checklist
• Risk Management File: Hazard analysis and mitigation (Risk Management)
• Test Reports from Approved Labs
• Labels and Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485:2016 certification preferred)

Import License Process (MD15) for Torque Wrench

Although this guide focuses on manufacturing, importers must obtain an MD15 license from the Central Licensing Authority. The import license process involves:

• Preparation of key documents like Free Sale Certificate, ISO certifications, CE Certificate, and existing manufacturing licenses.
• Application submission on the CDSCO MD Online Portal.
• Resolution of queries and grant of license within 5-6 months.

For detailed import licensing guidance, consult our Import License Guide.

Timeline and Processing Duration for Torque Wrench MD5 License

• Test License (MD13): 1.5 to 2 months
• Product Testing: 1 to 1.5 months (may overlap with test license period)
• Documentation & Application Preparation: 2 to 3 weeks
• Audit & Query Resolution: 1 to 1.5 months
• Total Estimated Time: Approximately 3 to 4 months from test license application to license grant

Government Fees and Costs for Torque Wrench MD5 License

• Application Fee: Rs 5,000 per application
• Product Fee: Rs 500 per product (Torque Wrench counts as one product)
• Testing Charges: Variable depending on the testing laboratory; typical range Rs 50,000 - Rs 1,00,000
• Notified Body Audit Fees: Varies; generally Rs 75,000 - Rs 1,50,000 depending on scope and location

Budgeting appropriately for these costs is essential to avoid delays.

Common Challenges and Solutions When Licensing Torque Wrench

• Incomplete Documentation: Manufacturers often submit insufficient technical files. Solution: Use detailed checklists and consult experienced regulatory professionals.
• Delays in Testing: Testing labs may have backlogs. Solution: Schedule tests early and choose labs with capacity.
• Audit Non-Compliance: Facilities may be unprepared for notified body audits. Solution: Conduct internal pre-audits and corrective actions.
• Query Resolution Delays: Slow responses can stall approval. Solution: Maintain clear communication channels and respond promptly.

Expert Consultation and Support

Our 25+ years of experience enable us to provide end-to-end support for Torque Wrench licensing—from compiling Device Master Files to coordinating tests and audits. We stay updated with CDSCO's evolving guidelines to ensure your application is accurate and compliant.

Getting Started with Your CDSCO License Application for Torque Wrench

1. Register on the CDSCO MD Online Portal and familiarize yourself with application forms MD3 and MD13.
2. Prepare your Device Master File and Plant Master File using our detailed guides linked above.
3. Apply for a Test License (Form MD13) to initiate the manufacturing of samples for testing.
4. Coordinate product testing with an approved laboratory early in the process.
5. Engage a Notified Body for audit readiness and schedule your audit.
6. Compile and submit your MD5 license application (Form MD3) once test results and audit reports are ready.
7. Maintain proactive communication with CDSCO officials during the query resolution phase.

Taking these actionable steps will streamline your licensing journey, enabling your Torque Wrench to enter the Indian market efficiently and compliantly.

For personalized assistance, do not hesitate to reach out to our expert regulatory team who have successfully guided over 500 companies through the CDSCO licensing process.