CDSCO License for Restorative Material

Comprehensive Guide to CDSCO Licensing for Restorative Material (Class B Dental Device)

As a trusted regulatory consulting firm with over 25 years of experience and more than 500 successful CDSCO license approvals, we understand the unique regulatory nuances of dental devices like Restorative Material. This device, classified as Class B under the Indian medical device regulations, serves critical roles such as dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and direct dental restorative material for cavity restoration in teeth. Given its direct application in oral healthcare, ensuring compliance with the CDSCO framework is essential for market access and patient safety.

CDSCO Regulatory Framework for Restorative Material (Class B Dental Device)

Restorative Materials fall under the dental device category and are regulated by the Central Drugs Standard Control Organization (CDSCO) as per the notification 29/Misc./03/2020-DC (140) Part-5 dated 10.10.2022. Class B devices are considered low to moderate risk, which places them under the State Licensing Authority’s jurisdiction for manufacturing licenses (MD5 License). Import licenses, if applicable, require Central Licensing Authority approval.

Risk Classification and License Requirements

According to CDSCO’s classification:

• Restorative Material is Class B (Low to Moderate Risk).
• Manufacturing License: MD5 License (Application Form MD3) issued by the State Licensing Authority.
• A mandatory Test License (Form MD13) must be obtained first for product testing.
• Testing must be conducted at CDSCO-approved laboratories.

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

Manufacturing License Process (MD5 License)

The manufacturing license process for Class B Restorative Material involves multiple critical steps:

1. Apply for Test License (Form MD13): This initial license allows the manufacture of limited quantities for testing purposes. The process generally takes about 1.5 to 2 months.
2. Product Testing: Samples must be tested at CDSCO notified testing laboratories to verify compliance with applicable standards. Refer to the Testing Laboratories list for approved facilities.
3. Document Preparation: Assemble all mandatory documentation including Device Master File, Plant Master File, Quality Management System (QMS) documents, and risk management files.
4. Application for Manufacturing License (Form MD3): Submit via the CDSCO MD Online Portal.
5. Audit by Notified Body: The manufacturing site undergoes an audit by a CDSCO-accredited notified body. You can check the Notified Bodies list to select your auditor.
6. Resolution of Queries: Address any observations or queries raised during the audit or by the State Licensing Authority.
7. Grant of License: Upon satisfactory compliance, the MD5 license is issued.

Manufacturing License Documents Required

For Class B Restorative Materials, the documentation checklist includes:

• Company Constitution (Incorporation Certificate, Partnership Deed, etc.)
• Proof of ownership or lease agreement for manufacturing premises
• Technical staff qualifications and experience details
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing product specifications, formulation, and manufacturing processes
• Plant Master File (PMF) describing facility layout, equipment, and manufacturing environment
• Essential Principles Checklist to demonstrate compliance with Indian regulatory standards
• Risk Management File outlining hazard analysis and mitigation strategies
• Product Test Reports from CDSCO-approved labs
• Labels, Instructions for Use (IFU), and packaging details
• Quality Management System (QMS) documentation including SOPs, CAPA, and training records

Our in-depth Device Master File guide and Plant Master File guide provide comprehensive templates and best practices.

Import License Process (MD15 License)

If you are an importer aiming to bring Restorative Materials into India, an MD15 Import License is mandatory. This license falls under the Central Licensing Authority and typically takes 5-6 months to process.

Key steps include:

1. Document Preparation: Collate Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, Device and Plant Master Files, Wholesale License, and Company Constitution.
2. License Application: Submit Form MD14 through the CDSCO MD Online Portal.
3. Queries Resolution: Respond to clarifications or additional information requests from CDSCO.
4. License Grant: Upon approval, you receive the MD15 license.

Import License Documents Required

• Valid Manufacturing License from manufacturer’s country
• Free Sale Certificate issued by the competent authority
• ISO 13485:2016 Certification
• CE Certificate or equivalent international certification
• Device Master File and Plant Master File
• Wholesale Drug License (if applicable)
• Company Constitution

Refer to our Import License Guide for step-by-step assistance.

Timeline and Processing Duration

• Test License (MD13): 1.5 to 2 months
• Product Testing: 1 to 2 months depending on laboratory workload
• Manufacturing License (MD5): 3 to 4 months inclusive of audit and query resolution
• Import License (MD15): 5 to 6 months

Planning ahead and early submission of complete documentation can significantly reduce delays.

Government Fees and Costs

• MD5 License: Rs 5,000 per application + Rs 500 per product
• MD13 Test License: Included within MD5 process
• MD15 Import License:
  • Class A: $1000 per site +$50 per product
  • Class B (Restorative Material): $2000 per site +$1000 per product
  • Payments are made online via CDSCO portal.

Common Challenges and Solutions

Challenge: Delays due to incomplete documentation Solution: Utilize detailed checklists and conduct internal audits before submission. We recommend reviewing your Device Master File and Risk Management File thoroughly to avoid rejections.

Challenge: Audit non-compliance Solution: Engage with a notified body early and perform mock audits to identify gaps.

Challenge: Testing laboratory backlogs Solution: Schedule testing well in advance and consider multiple CDSCO-approved labs.

Challenge: Query resolution delays Solution: Maintain prompt communication with CDSCO and prepare comprehensive responses with supporting evidence.

Expert Consultation and Support

Navigating CDSCO licensing for Class B dental restorative materials requires expertise and precision. Our consultancy has assisted over 500 manufacturers and importers in achieving successful approvals by delivering:

• Customized regulatory strategy
• Complete documentation preparation including DMF, PMF, Risk Management, and QMS
• Liaison with CDSCO and notified bodies
• Audit readiness and mock inspection services
• Post-license compliance support

Getting Started with Your CDSCO License Application

To initiate your licensing journey for Restorative Material:

1. Identify the Responsible Authority: For manufacturing, contact the State Licensing Authority; for import, the Central Licensing Authority.
2. Register on the CDSCO MD Online Portal: Create your account at CDSCO MD Online Portal.
3. Compile Required Documentation: Use our guides on Device Master File and Plant Master File to prepare.
4. Apply for Test License (MD13): Submit through the portal to start product testing.
5. Plan for Product Testing: Coordinate with CDSCO-approved labs early.
6. Prepare for Audit: Select a notified body from the list of notified bodies and schedule your audit.
7. Submit Manufacturing License Application (MD3): After successful testing and audit, apply for your MD5 license.

Our team is ready to guide you through every step, ensuring a smooth, compliant, and timely licensing process. Contact us today to leverage our proven expertise and accelerate your Restorative Material’s entry into the Indian market.