CDSCO License for Dental crown/bridge resin, temporary

Comprehensive Guide to CDSCO Licensing for Dental Crown/Bridge Resin (Temporary) – Class B Medical Device

Dental crown/bridge resin, temporary, is a specialized dental material used for fabricating temporary crowns and bridges. As a Class B medical device under CDSCO regulations, it demands strict adherence to regulatory frameworks to ensure safety, efficacy, and market access in India. With over 25 years of experience and having supported 500+ manufacturers, we provide you with a detailed roadmap to secure your CDSCO license efficiently.

CDSCO Regulatory Framework for Dental Crown/Bridge Resin (Temporary)

India’s Central Drugs Standard Control Organization (CDSCO) governs medical device approvals via the Medical Device Rules (MDR) 2017 and subsequent notifications. The device in question is notified under Notification number 29/Misc./03/2020-DC (140) Part-5 dated 10.10.2022, placing it firmly in Class B.

Class B devices are categorized as low moderate risk devices and require a manufacturing license (MD5) issued by the State Licensing Authority. Importers also need to comply with import licensing requirements (MD15).

Risk Classification and License Requirements

• Device Name: Dental crown/bridge resin, temporary
• Risk Class: B (Low moderate risk)
• Regulatory Category: Dental Material
• Applicable License: MD5 Manufacturing License (Form MD3)
• Licensing Authority: State Licensing Authority

For Class B devices, the MD5 license process involves initial test licensing, product testing, document submission, audit by a notified body, and final license grant.

Manufacturing License Process (MD5) for Dental Crown/Bridge Resin

The MD5 license is mandatory for manufacturers intending to produce this resin in India. The stepwise process includes:

1. Test License Application (Form MD13): This preliminary license allows you to manufacture the product for testing purposes. It typically takes 1.5 to 2 months to obtain.

2. Product Testing: Testing must be conducted at CDSCO-approved labs to verify compliance with Indian standards. Refer to the list of testing laboratories.

3. Document Preparation: Compile comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.

4. Submission of MD5 Application (Form MD3): File your application on the CDSCO MD Online Portal including all supporting documents.

5. Audit by Notified Body: Engage a notified body for an on-site audit. Check the list of notified bodies for authorized auditors.

6. Resolution of Queries: Address any observations or queries raised by the department or notified body.

7. Issuance of Manufacturing License (Form MD5): Upon satisfactory compliance, the license is granted.

Manufacturing License Documents Required

For Dental crown/bridge resin, the following documents must be meticulously prepared:

• Certificate of Incorporation and Company Constitution
• Proof of ownership or lease of manufacturing premises
• Details and qualifications of technical staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing product specifications (Device Master File guide)
• Plant Master File (PMF) outlining manufacturing processes (Plant Master File guide)
• Essential Principles Compliance Checklist
• Risk Management File with hazard analysis and mitigation (Risk Management)
• Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation (ISO 13485 compliance recommended)

Import License Process (MD15) for Dental Crown/Bridge Resin

If you are an importer of this device, an MD15 license from the Central Licensing Authority is required. The process entails:

1. Document Preparation: Compile Manufacturing License, Free Sale Certificate, ISO 13485:2016 Certificate, CE Certificate, DMF, PMF, Wholesale License, and Company Constitution.

2. Application Submission: Apply using Form MD14 on the CDSCO MD Online Portal.

3. Query Resolution: Respond promptly to any clarifications sought.

4. License Grant: Typically completed within 5-6 months.

Import License Documents Required

• Valid Manufacturing License from country of origin
• Free Sale Certificate issued by regulatory authority of the exporting country
• ISO 13485:2016 Certificate
• CE Certificate or equivalent
• Device Master File
• Plant Master File
• Wholesale Drug License in India
• Company Constitution and address proof

Timeline and Processing Duration

Government Fees and Costs

• MD5 License Application Fee: ₹5,000 per application
• Product Fee: ₹500 per product
• Testing Charges: Vary based on testing lab and number of tests; budget approximately ₹50,000 - ₹1,00,000
• Notified Body Audit Fee: Typically ₹75,000 - ₹1,50,000 depending on scope

Common Challenges and Solutions

• Delayed Test Reports: Proactively coordinate with CDSCO-approved labs early to avoid bottlenecks.
• Incomplete Documentation: Use detailed checklists and templates to ensure all files, especially DMF and PMF, meet CDSCO standards.
• Audit Non-Compliance: Engage experienced notified bodies and conduct pre-audit internal assessments.
• Query Resolution Delays: Assign a dedicated regulatory liaison for swift communication.

Expert Consultation and Support

Navigating CDSCO regulations for dental materials can be complex. Leveraging expert consultancy with extensive experience helps mitigate risks, optimize timelines, and ensure regulatory compliance. Our team specializes in:

• End-to-end licensing support for Class B devices
• Documentation and quality system development
• Liaison with CDSCO and notified bodies
• Post-license compliance and renewals

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm the Class B status and device details per the official Medical Device Classification.
2. Register on CDSCO MD Online Portal: Initiate company and product registration.
3. Plan Testing and Documentation: Identify CDSCO-approved labs and begin compiling Device and Plant Master Files.
4. Apply for Test License (Form MD13): Secure the test license to commence manufacturing for testing.
5. Schedule Audit with Notified Body: Early engagement accelerates the license issuance.

Embarking on this process with a structured, informed approach backed by proven expertise will facilitate your successful market entry and compliance with India's stringent medical device regulations.

For further guidance tailored to your specific manufacturing setup, contact our regulatory experts to streamline your CDSCO licensing journey.

References:

• Submit your application through the CDSCO MD Online Portal.
• Check the list of notified bodies for audit requirements.
• Find CDSCO-approved testing laboratories for product validation.
• Explore our comprehensive Device Master File guide.
• Understand Risk Management essentials for medical devices.