CDSCO License for Rubber dam clamp forceps

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

Rubber dam clamp forceps are essential hand-held dental instruments used specifically for the insertion and removal of rubber dam clamps, facilitating isolation during dental procedures. Classified under Class A (low risk) as per the CDSCO notification 29/Misc./03/2020-DC (140) Part-5 dated 10.10.2022, these devices require a streamlined but compliant regulatory approach to enter the Indian market.

With over 25 years of experience and having supported 500+ manufacturers and importers, we provide you with expert insights into obtaining the necessary CDSCO licenses for rubber dam clamp forceps, ensuring your product meets Indian regulatory standards efficiently.

CDSCO Regulatory Framework for Rubber Dam Clamp Forceps

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Devices Rules, 2017. Being a Class A device, rubber dam clamp forceps fall under low-risk category devices, governed primarily by State Licensing Authorities.

Regulation ensures that these dental instruments satisfy quality, safety, and efficacy norms before they reach the market, protecting patient safety and consumer confidence.

Risk Classification and License Requirements

• Device: Rubber Dam Clamp Forceps
• Risk Class: A (Low Risk)
• Category: Dental
• Applicable License: MD5 Manufacturing License (Form MD3)
• Regulatory Authority: State Licensing Authority

Class A devices require a manufacturing license (MD5) obtained through the State authority. The process involves obtaining a test license (MD13), product testing, documentation, audit by a notified body, and final license issuance.

For detailed classification, you can refer to the Medical Device Classification guide.

Manufacturing License Process (MD5) for Rubber Dam Clamp Forceps

1. Apply for Test License (Form MD13):

   • Duration: 1.5 to 2 months
   • Purpose: Allows batch testing of the device from an approved government testing laboratory

2. Product Testing:

   • Conduct testing at CDSCO-approved labs to verify compliance with Indian standards
   • Refer to the List of Testing Laboratories for authorized labs

3. Documentation Preparation:

   • Compile technical files, quality management documents, and other required records

4. Submit Application for Manufacturing License (Form MD3):

   • Submit via the CDSCO MD Online Portal

5. Audit by Notified Body:

   • A notified body conducts an on-site audit
   • See the List of Notified Bodies for approved agencies

6. Resolution of Queries:

   • Respond promptly to any queries raised by the licensing authority or notified body

7. Grant of Manufacturing License (Form MD5):

   • Typically issued within 3 to 4 months from initial application

Manufacturing License Documents Required for Rubber Dam Clamp Forceps

• Company constitution documents (e.g., MOA, AOA)
• Proof of ownership or lease of manufacturing premises
• Details and qualifications of technical staff
• Fire and pollution clearance certificates
• Device Master File (DMF): Technical specifications, design details, manufacturing processes. Our comprehensive Device Master File guide can help you prepare this critical document
• Plant Master File (PMF): Manufacturing facilities, equipment details, quality controls. Learn how to create this through our Plant Master File guide
• Essential Principles Compliance Checklist
• Risk Management File (per ISO 14971 standards). For best practices, see our Risk Management resource
• Product test reports from government-approved labs
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents (ISO 13485:2016 preferred)

Import License Process (MD15) for Rubber Dam Clamp Forceps

As rubber dam clamp forceps are Class A devices, importers must obtain the MD15 import license from the Central Licensing Authority.

• Application Form: MD14
• No test license required for import
• Submit application on the CDSCO MD Online Portal
• Required documents include:
  • Valid manufacturing license from the country of origin
  • Free Sale Certificate
  • ISO 13485:2016 and CE Certification
  • Device Master File and Plant Master File
  • Wholesale license
  • Company constitution documents

The import license process typically takes 5 to 6 months due to thorough document verification.

For comprehensive understanding, see our Import License guide.

Timeline and Processing Duration

Government Fees and Costs

• Test License (MD13): Included within application fees
• MD5 Manufacturing License Application Fees:
  • Rs. 5,000 per application
  • Rs. 500 per product

Additional costs may include:

• Testing fees charged by government-approved laboratories
• Audit fees charged by notified bodies
• Consultancy fees if opting for professional regulatory assistance

Common Challenges and Solutions

Challenge: Delays in product testing due to laboratory backlogs

• Solution: Schedule testing early and choose labs with shorter turnaround times from the approved testing labs list.

Challenge: Incomplete or inconsistent documentation

• Solution: Follow a comprehensive checklist, and utilize our guides on Device Master File and Plant Master File preparation to avoid omissions.

Challenge: Queries from notified bodies during audit

• Solution: Prepare your QMS thoroughly and conduct internal audits before the official audit to identify gaps.

Challenge: Delays in application processing

• Solution: Regularly monitor application status on the CDSCO MD Online Portal and respond promptly to any queries.

Expert Consultation and Support

Navigating CDSCO licensing can be complex, especially for manufacturers new to the Indian regulatory environment. Our 25+ years of experience and a track record of over 500 successful approvals make us your ideal partner.

We offer tailored regulatory consulting services, including:

• Gap analysis of your current documentation
• Preparation and review of Device and Plant Master Files
• Assistance in product testing coordination
• Support during notified body audits
• End-to-end license application management

Getting Started with Your CDSCO License Application for Rubber Dam Clamp Forceps

1. Register on the CDSCO MD Online Portal: Begin by creating an account at the CDSCO MD Online Portal. This portal is central to all submissions and communications.

2. Prepare your documentation: Use our detailed guides on Device Master File and Plant Master File to compile your documents accurately.

3. Apply for the Test License (MD13): This is your first regulatory step to enable product testing.

4. Coordinate product testing: Engage with government-approved testing laboratories early.

5. Plan your notified body audit: Select an approved notified body from the list here and schedule your audit.

6. Submit the MD5 license application (Form MD3): Once testing and audit are complete, apply formally for your manufacturing license.

7. Track and respond: Monitor your application status and promptly address any department queries.

By following these pragmatic steps, your rubber dam clamp forceps can successfully gain CDSCO approval, unlocking access to the expanding Indian dental device market.

For personalized support and expedited licensing, feel free to reach out to our regulatory experts who specialize in dental device approvals.

Embark on your regulatory journey confidently with our proven expertise and practical guidance tailored to your rubber dam clamp forceps manufacturing or import business.