CDSCO License for Vice Grip

Comprehensive Guide to CDSCO Licensing for Vice Grip (Class A Medical Device)

As specialists with over 25 years of experience in medical device regulatory affairs, having supported 500+ companies successfully obtain CDSCO licenses, we provide you with expert insights tailored for the Vice Grip — a Class A medical device used to hold pliers, categorized under General Hospital or Orthopaedic Instruments. Our goal is to simplify your path to market entry in India by detailing the regulatory framework, timelines, document requirements, costs, and practical tips for securing your manufacturing license.

CDSCO Regulatory Framework for Vice Grip

The Vice Grip, notified under 29/Misc./03/2020-DC (193)- Part-3 on 16.03.2022, falls under the Indian medical device regulations governed by the Central Drugs Standard Control Organisation (CDSCO). As a Class A device, it is considered low risk and regulated at the State Licensing Authority level. Compliance with the Medical Device Rules, 2017, including essential principles and quality management system requirements, is mandatory.

Risk Classification and License Requirements

• Device: Vice Grip
• Risk Class: A (Low risk)
• License Type: MD5 Manufacturing License
• Governing Authority: State Licensing Authority

Class A devices require an MD5 license, which involves a stepwise process including obtaining a Test License (Form MD13), product testing at government-approved laboratories, audit by a notified body, and final license grant.

Manufacturing License Process (MD5)

1. Test License Application (Form MD13): Obtain a test license allowing initial production for testing purposes.
2. Product Testing: Conduct mandatory tests at CDSCO-approved labs.
3. Document Preparation: Compile technical and quality documents.
4. Applying for MD5 License (Form MD3): Submit the manufacturing license application via the CDSCO MD Online Portal.
5. Audit by Notified Body: Engage with an approved notified body from the Notified Bodies List for MD5 Audit for site inspection and compliance verification.
6. Query Resolution: Respond promptly to any queries from CDSCO or the notified body.
7. License Issuance: Receive the formal manufacturing license (Form MD5).

Manufacturing License Documents Required

For Vice Grip manufacturing license (MD5), prepare the following documents carefully:

• Company Constitution: MOA/AOA or Partnership Deed
• Proof of Premises Ownership/Lease: Valid property documents
• Technical Staff Details: Qualifications and experience certificates
• Fire NOC: Clearance from local fire department
• Pollution Control NOC: Environmental clearance
• Device Master File (DMF): Comprehensive product details, manufacturing process, and specifications. Our detailed Device Master File guide can help you prepare this.
• Plant Master File (PMF): Facility and quality system overview; refer to our Plant Master File Guide
• Essential Principles Checklist: Compliance matrix with Indian regulatory requirements
• Risk Management File: Risk analysis and mitigation for Vice Grip (see our Risk Management resource)
• Test Reports: From CDSCO-approved labs listed on Testing Laboratories
• Product Labels and Instructions for Use (IFU): Compliant with CDSCO labeling standards
• Quality Management System (QMS) Documents: SOPs, CAPA, change control, etc.

Import License Process (MD15)

While this guide focuses on manufacturing, importers of Vice Grip devices must apply for an MD15 import license through the Central Licensing Authority. The process involves:

• Document preparation including Manufacturing License, Free Sale Certificate, ISO 13485:2016, CE certificate, and other relevant documents
• Application submission on the CDSCO MD Online Portal
• Resolution of queries
• License grant

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

Import License Documents Required

• Valid Manufacturing License from country of origin
• Free Sale Certificate from regulatory authority of exporting country
• ISO 13485:2016 certification
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale license (for importers/distributors)
• Company Constitution

Timeline and Processing Duration

Total Estimated Time: Approximately 3 to 4 months from start to finish.

Government Fees and Costs

• Test License (MD13): Nominal fee as per CDSCO norms
• MD5 Manufacturing License Application Fee: ₹5,000 per application
• Per Product Fee: ₹500
• Audit and Testing Costs: Variable, depending on notified body and testing lab charges

Budget approximately ₹75,000 to ₹1,00,000 to cover all fees, testing, and audit expenses.

Common Challenges and Solutions

• Delay in Test Report Submission: Engage early with CDSCO-approved labs. Use the Testing Laboratories list to select labs with good turnaround times.
• Incomplete Documentation: Follow our checklists strictly. Cross-reference with the Device and Plant Master File guides to avoid omissions.
• Audit Non-conformities: Conduct internal audits beforehand and train your staff on CDSCO compliance requirements.
• Query Resolution Delays: Assign a dedicated regulatory liaison to respond promptly to CDSCO and notified body queries.

Expert Consultation and Support

Navigating CDSCO licensing can be complex, especially for first-time applicants. Our team has helped over 500 companies streamline their applications for devices like the Vice Grip. We offer:

• Tailored document preparation support
• Mock audit services
• Liaison with notified bodies and CDSCO
• Post-license compliance assistance

Connect with us early to avoid costly delays and maximize your approval chances.

Getting Started with Your CDSCO License Application

1. Assess your device classification: Confirm Vice Grip as Class A using the Medical Device Classification resource.
2. Prepare your test license application: Submit Form MD13 on the CDSCO MD Online Portal to begin production for testing.
3. Select a notified body: Refer to the Notified Bodies List for MD5 Audit and engage early.
4. Initiate lab testing: Coordinate with CDSCO-approved labs for product testing.
5. Compile and review documentation: Use our comprehensive guides for Device and Plant Master Files.
6. Submit your MD5 manufacturing license application: Apply via the CDSCO portal using Form MD3.
7. Prepare for audit and promptly address queries: Maintain clear communication channels.

By following these actionable steps and leveraging our expertise, you can confidently navigate the regulatory landscape and bring your Vice Grip device to the Indian market efficiently and compliantly.