CDSCO License for Forceps

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

Forceps are essential surgical instruments used extensively in hospitals and orthopaedic settings to grasp, manipulate, compress, pull, or join tissue and supplies. This category includes a variety of specialized forceps such as Burns for Radius, Modified Burns, Martins Cartilage Forceps, Sequestum Forceps, and Bone Holding Forceps like Fergussons or Haygroves types. Under CDSCO regulations, forceps fall under Class A (low-risk) medical devices, specifically categorized under General Hospital or Orthopaedic Instruments. Proper regulatory approval via a CDSCO manufacturing or import license is critical for market access in India.

With over 25 years of experience supporting 500+ companies in navigating CDSCO registrations and licensing, we provide you with a detailed, practical roadmap to obtain your MD5 license for manufacturing Class A forceps.

CDSCO Regulatory Framework for Forceps (Class A)

Forceps are regulated under the Medical Device Rules (MDR) 2017, as notified in the Gazette Notification 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022. Being a Class A device, forceps are considered low risk, subject to State Licensing Authority jurisdiction. The manufacturing license required is the MD5 license, governed under Form MD3 application.

The regulatory framework mandates compliance with Good Manufacturing Practices (GMP), product testing from CDSCO-approved laboratories, and documentation that demonstrates compliance with Essential Principles for Safety and Performance.

Risk Classification and License Requirements for Forceps

Forceps are classified under Class A devices:

• Risk Class: Low risk
• License Type: MD5 Manufacturing License (Form MD3)
• Licensing Authority: State Licensing Authority

This classification allows a streamlined licensing process compared to higher-risk devices but still requires strict adherence to documentation, testing, and quality management system (QMS) standards.

Manufacturing License Process for Forceps (MD5 License)

Obtaining an MD5 manufacturing license involves several sequential steps:

1. Test License (Form MD13): First, apply for a test license which typically takes 1.5 to 2 months to obtain. This allows you to manufacture the device in limited quantities for testing purposes.

2. Product Testing: Get your forceps tested at CDSCO-approved laboratories to demonstrate compliance with applicable Indian Standards or international equivalents. Refer to the list of Testing Laboratories for approved facilities.

3. Document Preparation: Prepare comprehensive technical documentation including Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, Risk Management File, QMS documents, and more.

4. Application Submission: Submit your MD5 license application on the CDSCO MD Online Portal using Form MD3.

5. Audit by Notified Body: A notified body will conduct an audit of your manufacturing facility and quality system. Check the list of notified bodies.

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

7. Grant of License: Upon satisfactory compliance, the MD5 license will be issued.

For more details, our MD5 License Guide provides an in-depth walkthrough.

Manufacturing License Documents Required for Forceps

The following documentation is mandatory for the MD5 license application:

• Company Constitution (e.g., MOA, AOA)
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Details and qualifications of Technical Staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing design, specifications, and manufacturing process. See our Device Master File Guide.
• Plant Master File (PMF) describing facility layout, equipment, and quality assurance systems. Learn more at our Plant Master File Guide.
• Essential Principles Checklist demonstrating compliance with safety and performance requirements
• Risk Management File per ISO 14971 standards. Visit our Risk Management resource for best practices.
• Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, typically ISO 13485:2016 certified

Import License Process for Forceps (MD15 License)

If you intend to import forceps into India, an MD15 import license is mandatory. This process is managed by the Central Licensing Authority and typically takes 5 to 6 months.

Steps include:

• Preparation of import documentation
• Submission of application via Form MD14 on the CDSCO MD Online Portal
• Review and query resolution
• Grant of MD15 import license

Required documents include:

• Valid manufacturing license from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale License
• Company Constitution

Refer to our Import License Guide for full details.

Timeline and Processing Duration

Timelines may vary based on audit scheduling and query resolution speed.

Government Fees and Costs

For Class A devices like forceps, the fee structure is as follows:

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

Additional costs include:

• Testing laboratory fees (variable depending on tests)
• Notified body audit fees
• Consultancy fees if applicable

Budgeting accurately for these costs upfront can prevent delays.

Common Challenges and Solutions

• Incomplete Documentation: Missing or insufficient documents cause delays. Use detailed checklists and expert review before submission.
• Delayed Testing: Plan early engagement with testing labs to avoid bottlenecks.
• Audit Non-compliance: Implement a robust QMS and conduct internal audits before notified body inspections.
• Query Resolution Delays: Maintain proactive communication and keep regulatory experts on standby to address queries promptly.

Expert Consultation and Support

Navigating CDSCO licensing can be complex. With our 25+ years of experience and a proven track record of 500+ successful licenses, we provide end-to-end support:

• Gap analysis of your current compliance status
• Preparation and review of technical documentation
• Coordination with testing labs and notified bodies
• Assistance with application submission and audit readiness

Our tailored approach ensures minimal delays and maximizes your chances of timely approval.

Getting Started with Your CDSCO License Application for Forceps

1. Assess your product classification: Confirm forceps as Class A devices.
2. Initiate test license application: Submit Form MD13 on the CDSCO MD Online Portal.
3. Engage a CDSCO-approved testing laboratory: Schedule product testing early.
4. Prepare your technical documentation: Utilize our Device and Plant Master File guides.
5. Plan your QMS and internal audit schedule: Ensure compliance with ISO 13485:2016.
6. Apply for MD5 license: Submit Form MD3 after completing test license and testing.
7. Prepare for audit: Coordinate with notified bodies listed here.

Starting early and maintaining organized documentation will streamline your licensing journey. Reach out to expert consultants to assist you in every step and avoid common pitfalls.

This comprehensive guide empowers manufacturers and importers of forceps to confidently navigate the CDSCO regulatory process, ensuring compliance and successful market entry in India.