CDSCO License for Orthodontic Elastomeric

Comprehensive CDSCO Licensing Guide for Orthodontic Elastomeric Devices (Class A Dental Device)

Orthodontic Elastomeric devices, classified as Class A medical devices under the CDSCO regulatory framework, play a crucial role in orthodontic care by controlling tooth position and preventing relapse post-treatment. As a trusted regulatory consultancy with over 25 years of experience supporting 500+ companies, we understand the nuances and critical steps manufacturers and importers must navigate to obtain CDSCO licenses efficiently.

CDSCO Regulatory Framework for Orthodontic Elastomeric Devices

India's Central Drugs Standard Control Organization (CDSCO) governs the import and manufacture of medical devices through a structured licensing framework aligned with device risk classification. Orthodontic Elastomeric devices fall under the dental category and Risk Class A, making them subject to state-level licensing via the MD5 license process. This ensures product safety, quality, and compliance before market entry.

Risk Classification and License Requirements for Orthodontic Elastomeric

• Device Name: Orthodontic Elastomeric
• Risk Class: A (Low risk)
• Category: Dental
• Intended Use: Tooth positioner/instrument to control settling and minimize relapse after orthodontic treatment
• Notification: 29/Misc./03/2020-DC (140) Part-5
• Notification Date: 10.10.2022

As a Class A device, the manufacturing license is granted by the State Licensing Authority through the MD5 license (Form MD3). Importers also require an MD15 import license from the Central Licensing Authority, but this guide focuses on manufacturing.

Manufacturing License Process (MD5) for Orthodontic Elastomeric

The MD5 license process comprises several critical stages, including obtaining a test license, product testing, document compilation, audit by a notified body, and final license issuance.

1. Test License (Form MD13): Initiate by applying for a test license on the CDSCO MD Online Portal. This license is mandatory for sample testing and typically takes 1.5 to 2 months for approval.

2. Product Testing: Conduct product tests at government-approved laboratories listed on the CDSCO Testing Laboratories page. Testing ensures compliance with relevant standards and safety requirements.

3. Document Preparation: Prepare comprehensive documentation, including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documents.

4. Audit by Notified Body: Coordinate a plant audit with a notified body from the CDSCO Notified Bodies List. The audit assesses compliance with Good Manufacturing Practices (GMP) and regulatory standards.

5. Submission and Review: Submit the manufacturing license application (Form MD3) via the CDSCO MD Online Portal. The authority reviews submitted documents and audit reports, raising queries if necessary.

6. Grant of License: Upon satisfactory resolution of queries, the license is granted on Form MD5, authorizing manufacturing operations.

Manufacturing License Documents Required for Orthodontic Elastomeric

To ensure a smooth application process, gather the following mandatory documents:

• Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
• 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) outlining product specifications and compliance (Device Master File Guide)
• Plant Master File (PMF) describing manufacturing environment and processes (Plant Master File Guide)
• Essential Principles Checklist demonstrating conformity with Indian regulations
• Risk Management File specific to the orthodontic elastomeric device (Risk Management)
• Test Reports from government-approved laboratories
• Labels and Instructions for Use (IFU) compliant with CDSCO guidelines
• Quality Management System Documents (ISO 13485 certification recommended)

Import License Process (MD15) for Orthodontic Elastomeric

If you plan to import orthodontic elastomeric devices instead of manufacturing locally, an MD15 import license from the Central Licensing Authority is mandatory. The process involves:

• Document preparation, including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, and Device & Plant Master Files
• Application submission via the CDSCO MD Online Portal
• Queries resolution
• License issuance on Form MD15, typically within 5 to 6 months

For detailed guidance, visit our Import License Guide.

Timeline and Processing Duration

• Test License (MD13): 1.5 to 2 months
• Product Testing: 1 to 1.5 months (concurrent with document preparation)
• Audit by Notified Body: Scheduled typically 1 month post testing
• Application Review and License Grant: 1 to 1.5 months

Total Estimated Time: Approximately 3 to 4 months from test license application to MD5 license grant.

Government Fees and Costs

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

Additional costs include testing laboratory fees and notified body audit charges, which vary based on the scope and laboratory selected.

Common Challenges and Solutions

Challenge: Delays due to incomplete documentation or non-compliance with essential principles.

Solution: Engage early with regulatory consultants to prepare comprehensive, compliant documents. Utilize our detailed checklists and templates for Device Master File, Plant Master File, and Risk Management.

Challenge: Scheduling audits with notified bodies amidst high demand.

Solution: Book audits in advance through the CDSCO notified bodies list and maintain open communication to avoid bottlenecks.

Challenge: Product testing failures or delays.

Solution: Select accredited laboratories with experience in dental device testing and conduct pre-tests internally to identify issues early.

Expert Consultation and Support

With our extensive experience assisting over 500 companies in India’s medical device market, we offer personalized support from document preparation to audit coordination. Our expert team ensures compliance with the latest CDSCO notifications, including the recent Notification 29/Misc./03/2020-DC (140) Part-5 dated 10.10.2022, specifically covering dental devices like Orthodontic Elastomeric.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your device falls under Class A using the Medical Device Classification guide.

2. Initiate Test License Application: Submit your Form MD13 application through the CDSCO MD Online Portal.

3. Prepare Documentation: Begin compiling your Device Master File, Plant Master File, Risk Management File, and QMS documents.

4. Schedule Product Testing: Coordinate with government-approved laboratories for mandatory testing.

5. Plan for Audit: Contact notified bodies early to schedule your GMP audit.

6. Submit Manufacturing License Application: Once testing and audit are complete, apply for the MD5 license via the online portal.

By following this roadmap and leveraging our expert guidance, manufacturers and importers of Orthodontic Elastomeric devices can confidently navigate the CDSCO licensing process, ensuring timely market access and regulatory compliance.

For tailored assistance, please contact our regulatory consulting team to start your CDSCO license application journey today.