CDSCO License for Box Wrench for Nut/Bolt

Comprehensive Guide to CDSCO Licensing for Box Wrench for Nut/Bolt (Class A Medical Device)

As seasoned regulatory consultants with over 25 years of experience helping 500+ medical device companies successfully navigate CDSCO licensing, we understand the intricacies involved in bringing medical devices like the Box Wrench for Nut/Bolt to the Indian market. This minimally invasive, reusable surgical instrument classified under Class A (low risk) requires a well-structured approach to comply with Indian regulations. Here, we provide a detailed, step-by-step guide to securing the CDSCO license essential for legal manufacturing and marketing.

Understanding the CDSCO Regulatory Framework for Box Wrench (Class A Device)

The Box Wrench falls under the category of General Hospital or Orthopaedic Instruments as per the CDSCO notification 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022. Classified as a Class A medical device, it is considered low risk and regulated by the State Licensing Authority under the MD5 license regime in India.

India’s Central Drugs Standard Control Organisation (CDSCO) mandates all medical devices to comply with the Medical Device Rules, 2017, ensuring safety, efficacy, and quality. Class A devices require manufacturers to obtain a manufacturing license (MD5) issued by the respective State Drug Control Department.

Risk Classification and License Requirements for Box Wrench

• Device Risk Class: Class A (Low Risk)
• Regulatory License: MD5 Manufacturing License (Form MD3)
• Regulatory Authority: State Licensing Authority
• Test License: Mandatory Test License (Form MD13) before MD5 application
• Auditing: Conducted by a notified body appointed by CDSCO

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

Step-by-Step Manufacturing License Process (MD5) for Box Wrench

1. Apply for Test License (Form MD13):

   • Submit initial application for test license through the CDSCO MD Online Portal.
   • Duration: Approximately 1.5 to 2 months.

2. Product Testing:

   • Get the Box Wrench tested at CDSCO-approved laboratories to validate safety and performance.
   • Refer to the list of Testing Laboratories approved by CDSCO.

3. Document Preparation:

   • Prepare comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documents.
   • Consult our Device Master File guide and Plant Master File guide for best practices.

4. Apply for MD5 License (Form MD3):

   • Submit a complete application with all required documents on the CDSCO MD Online Portal.

5. Audit by Notified Body:

   • An audit of manufacturing premises and QMS will be conducted by a notified body from the official list.

6. Query Resolution:

   • Address any queries raised by CDSCO or the notified body promptly to avoid delays.

7. Grant of License:

   • Upon successful audit and compliance, the State Licensing Authority issues the MD5 license on Form MD5.

Manufacturing License Documents Required for Box Wrench (Class A)

To streamline your application, ensure all the following documents are meticulously prepared:

• Company Constitution (e.g., MOA, AOA)
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Credentials of Technical Staff
• Fire NOC and Pollution Control Board NOC
• Device Master File specific to Box Wrench
• Plant Master File detailing manufacturing facilities
• Essential Principles Checklist confirming compliance to safety standards
• Risk Management File aligned with ISO 14971 principles (Risk Management guide)
• Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documents (preferably ISO 13485:2016 certified)

Import License Process (MD15) - Not Applicable for Manufacturing

For manufacturers, the import license process (MD15) is generally not required unless you plan to import components or finished devices. However, importers of devices like the Box Wrench must apply for an MD15 license through the Central Licensing Authority, which typically takes 5-6 months.

For comprehensive guidance on imports, our Import License guide is a valuable resource.

Timeline and Processing Duration for Box Wrench Licensing

• Test License (MD13): 1.5 to 2 months
• Product Testing: 1 to 1.5 months (may vary depending on lab capacity)
• Document Preparation: Ongoing, ideally started in parallel
• MD5 Application Processing: 1.5 to 2 months including audit and query resolution

Total estimated time: 3 to 4 months from initial application to license grant.

Government Fees and Costs for MD5 License

• Application fee: ₹5,000 per application
• Product fee: ₹500 per product

These fees apply per manufacturing site and product. Budgeting for notified body audit costs and laboratory testing fees (which vary by lab) is also essential.

Common Challenges and Practical Solutions

• Challenge: Incomplete or inconsistent documentation leads to repeated queries.

  • Solution: Leverage our checklists and expert document reviews before submission.

• Challenge: Delays in obtaining product test reports.

  • Solution: Engage with CDSCO-approved labs early; prioritize testing slots.

• Challenge: Audit non-compliance due to QMS gaps.

  • Solution: Implement ISO 13485:2016 standards proactively and prepare for notified body audits by conducting internal pre-audits.

• Challenge: Navigating online portal complexities.

  • Solution: Our team offers hands-on assistance for smooth portal submissions.

Expert Consultation and Support

With a proven track record of handling over 500 successful CDSCO license applications, our team provides:

• Customized regulatory roadmaps for your Box Wrench manufacturing setup
• End-to-end documentation preparation and review
• Coordination with notified bodies and CDSCO officials
• Training on compliance to minimize audit risks

Partnering with experienced consultants can significantly reduce approval timelines and ensure regulatory compliance.

Getting Started with Your CDSCO License Application for Box Wrench

1. Assess Your Manufacturing Setup: Confirm premises ownership, technical staff qualifications, and QMS status.
2. Initiate Test License Application: Submit Form MD13 via the CDSCO MD Online Portal.
3. Schedule Product Testing: Book slots at CDSCO-approved labs early to avoid bottlenecks.
4. Prepare Documentation: Assemble and review your Device Master File, Plant Master File, Risk Management File, and other essential documents.
5. Engage a Notified Body: Identify and communicate with a notified body from the official list for audit readiness.
6. Submit MD5 License Application: Upon successful test license and testing, apply using Form MD3 on the CDSCO portal.
7. Respond to Queries Promptly: Expedite the process by addressing all departmental and auditor queries without delay.

Embarking on the CDSCO licensing journey with clear steps and expert guidance ensures your Box Wrench for Nut/Bolt can reach healthcare professionals in India efficiently and compliantly. For personalized consultation, contact us today to leverage our deep regulatory expertise.