CDSCO License for Tooth extraction forceps

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

As a trusted regulatory consultancy with over 25 years of experience and more than 500 successful CDSCO license applications, we understand the nuances involved in bringing dental surgical instruments like Tooth Extraction Forceps to the Indian market. This guide provides detailed, practical insights into the regulatory framework, timelines, costs, and documentation required to obtain the Manufacturing License (MD5) for this Class A device.

Introduction: Tooth Extraction Forceps and Regulatory Importance

Tooth extraction forceps are essential hand-held manual dental surgical instruments shaped like pincers, specifically designed for the extraction of teeth. Classified under Dental devices, they fall into Class A risk category according to CDSCO’s regulation, indicating a low-risk profile but still require strict adherence to regulatory norms to ensure safety and efficacy.

Given the device’s direct interaction with patients, obtaining a valid CDSCO license is not just a legal requirement but a critical step to gain trust among dental professionals and distributors in India. Non-compliance can lead to severe business setbacks including product bans and financial penalties.

CDSCO Regulatory Framework for Tooth Extraction Forceps

The regulatory framework for medical devices in India is governed by the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare. Tooth extraction forceps are notified under the notification number 29/Misc./03/2020-DC (140) Part-5 dated 10.10.2022, which explicitly classifies them as Class A devices.

Manufacturers of such devices must apply for a manufacturing license under the MD5 category through the State Licensing Authority, as per the Medical Device Rules (MDR) 2017.

Risk Classification and License Requirements for Tooth Extraction Forceps

• Risk Class: A (Low risk)
• License Type: MD5 Manufacturing License
• Regulatory Authority: State Licensing Authority
• Application Form: MD3 for manufacturing license, MD13 for test license

Class A devices like tooth extraction forceps require a test license first, followed by product testing, documentation, and an audit by a notified body before obtaining the final manufacturing license.

Manufacturing License Process (MD5) for Tooth Extraction Forceps

1. Apply for Test License (Form MD13): The initial step involves obtaining a test license which takes approximately 1.5 to 2 months. This license allows you to legally manufacture the device for testing purposes.

2. Product Testing: Get your tooth extraction forceps tested at CDSCO-approved laboratories to ensure compliance with quality and safety standards. Refer to the Testing Laboratories list for authorized labs.

3. Document Preparation: Prepare and compile all required documents including Device Master File and Plant Master File.

4. Application for Manufacturing License (Form MD3): Submit your manufacturing license application through the CDSCO MD Online Portal.

5. Audit by Notified Body: A notified body will conduct an on-site audit of your manufacturing facility. You can check the list of notified bodies authorized for MD5 audits.

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

7. Grant of License: Upon satisfactory compliance, the State Licensing Authority will grant the MD5 manufacturing license (Form MD5).

Manufacturing License Documents Required for Tooth Extraction Forceps

• Company Constitution: Proof of incorporation or partnership details.
• Proof of Ownership or Lease of Premises: Valid property documents.
• Technical Staff Details: Qualifications and experience certificates of technical personnel.
• Fire NOC & Pollution Control NOC: Relevant clearances from local authorities.
• Device Master File (DMF): Detailed product description, design, manufacturing process, and testing protocols. Our Device Master File guide provides a stepwise approach.
• Plant Master File (PMF): Details of manufacturing site, equipment, and quality control processes. Refer to our Plant Master File guide.
• Essential Principles Checklist: Compliance checklist with CDSCO’s essential principles.
• Risk Management File: Risk analysis and mitigation strategies tailored to tooth extraction forceps. Learn more about risk management.
• Test Reports: From CDSCO-approved laboratories.
• Labels and Instructions for Use (IFU): As per regulatory norms.
• Quality Management System (QMS) Documents: ISO 13485 certification or equivalent.

Import License Process (MD15) for Tooth Extraction Forceps

If you plan to import tooth extraction forceps into India, an Import License (MD15) from the Central Licensing Authority is mandatory. The process includes:

1. Document Preparation: Includes manufacturing license from country of origin, Free Sale Certificate, ISO 13485 certificate, CE Certificate, Device and Plant Master Files, wholesale license, and company constitution.

2. Application Submission: File your application on the CDSCO MD Online Portal.

3. Query Resolution: Respond to any queries from CDSCO.

4. Grant of License: Typically takes 5-6 months.

For detailed guidance, see our Import License guide.

Timeline and Processing Duration

• Test License (MD13): 1.5 to 2 months
• Product Testing: 3 to 4 weeks (depending on lab workload)
• Manufacturing License (MD5): 3 to 4 months including audit and query resolution
• Total Time: Approximately 4 to 5 months from start to finish

Government Fees and Costs

• Test License Fee: Included within the MD5 application process
• MD5 Manufacturing License Fee: Rs. 5,000 per application plus Rs. 500 per product

For tooth extraction forceps (typically a single product), expect to pay around Rs. 5,500 in total license fees.

Common Challenges and Solutions

• Delayed Testing: Labs may have backlogs; plan testing early and select multiple approved labs from the Testing Laboratories list.
• Incomplete Documentation: Use our detailed checklists for Device Master File and Plant Master File to avoid rejection.
• Audit Non-Compliance: Thoroughly prepare your QMS and technical staff for audits; mock audits can be invaluable.
• Query Resolution Delays: Respond promptly with complete information to avoid prolonged processes.

Expert Consultation and Support

With our extensive experience guiding over 500 manufacturers through the CDSCO licensing process, we provide:

• Comprehensive document preparation and review
• Support in scheduling and preparing for notified body audits
• Assistance with product testing coordination
• Timely follow-up and query management

Our expert team ensures your tooth extraction forceps enter the Indian market smoothly and compliantly.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your device falls under Class A for tooth extraction forceps.
2. Register on CDSCO MD Online Portal: Create your account to access application forms and track submissions.
3. Prepare Initial Documents: Begin compiling the Device Master File and Plant Master File.
4. Apply for Test License (MD13): Submit this as the first formal step.
5. Coordinate Product Testing: Engage with approved labs early to avoid delays.
6. Plan for Audit: Schedule audits with notified bodies listed on the portal.

Embarking on this journey with a clear roadmap reduces risks and accelerates your market entry. For personalized assistance, connect with our regulatory consultants today.

For more detailed information, visit the CDSCO MD Online Portal and explore our expert guides on MD5 license and Device Master Files.

By following this structured approach and leveraging expert support, manufacturers of tooth extraction forceps can confidently obtain their CDSCO MD5 license and successfully commercialize their products in the Indian dental device market.