CDSCO License for Orthopaedic dental file

Comprehensive Guide to CDSCO Licensing for Orthopaedic Dental File (Class B Medical Device)

Orthopaedic dental files are specialized hand-held surgical instruments designed to enlarge and shape root canals during dental procedures. As a Class B medical device under the CDSCO regulatory framework, these instruments require a meticulous licensing process to ensure safety, efficacy, and compliance with Indian medical device regulations.

With over 25 years of experience and having supported more than 500 manufacturers navigate CDSCO licensing, we provide you with a detailed roadmap to obtain your MD5 manufacturing license and import license if applicable for Orthopaedic dental files.

CDSCO Regulatory Framework for Orthopaedic Dental Files

Orthopaedic dental files fall under the Dental category notified under 29/Misc./03/2020-DC (140) Part-5 with the notification date of 10.10.2022. According to CDSCO, these devices are classified as Class B due to their moderate risk profile, requiring state-level licensing through the MD5 route.

The regulatory framework mandates compliance with the Medical Device Rules, 2017, under the Drugs and Cosmetics Act, 1940. These rules emphasize product safety, technical documentation, quality management, and post-market surveillance.

Risk Classification and License Requirements for Class B Devices

Class B devices like Orthopaedic dental files require:

• Manufacturing License (MD5) granted by the State Licensing Authority
• Test License (MD13) for initial product testing
• Periodic audit by a notified body

For importers, an MD15 import license from the Central Licensing Authority is required, accompanied by relevant manufacturing and quality documentation.

Manufacturing License Process (MD5) for Orthopaedic Dental Files

The MD5 licensing process typically spans 3 to 4 months and involves the following key steps:

1. Apply for Test License (Form MD13): This 1.5 to 2-month phase allows you to legally test the device in CDSCO-approved laboratories.
2. Product Testing: Send your Orthopaedic dental files to government-approved labs for necessary mechanical and biocompatibility tests. Refer to the CDSCO Testing Laboratories list for approved facilities.
3. Preparation of Technical Documentation: Compile Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documents.
4. Application Submission (Form MD3): File your manufacturing license application through the CDSCO MD Online Portal.
5. Audit by Notified Body: Engage a notified body from the CDSCO Notified Bodies List for on-site inspection.
6. Resolution of Queries: Address any observations or clarifications required by the department or notified body.
7. Grant of License (Form MD5): Upon satisfactory compliance, the State Licensing Authority issues the manufacturing license.

Manufacturing License Documents Required for Orthopaedic Dental Files

Ensure you have the following comprehensive documentation ready:

• Company Constitution and Certificate of Incorporation
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Technical Staff Qualification and Experience Certificates
• Fire Safety and Pollution Control NOCs
• Device Master File (DMF) detailing design, specifications, and validations (DMF Guide)
• Plant Master File (PMF) describing manufacturing processes and controls (PMF Guide)
• Essential Principles Checklist confirming compliance with regulatory requirements
• Risk Management File aligned with ISO 14971 principles (Risk Management Guide)
• Test Reports from CDSCO-approved labs
• Labels and Instructions for Use (IFU)
• Quality Management System Documents (preferably ISO 13485:2016 certified)

Import License Process (MD15) for Orthopaedic Dental Files

If you are importing this device into India, the MD15 license is mandatory. The process generally takes 5 to 6 months and includes:

1. Preparation of import dossier including manufacturing and quality certificates
2. Application submission on the CDSCO MD Online Portal
3. Departmental scrutiny and resolution of queries
4. Issuance of Import License (Form MD15) by the Central Licensing Authority

Import License Documents Required

• Valid Manufacturing License of the product in the country of origin
• Free Sale Certificate or Certificate to Foreign Government
• ISO 13485:2016 Certificate for Quality Management System
• CE Certificate or equivalent regulatory approval
• Device Master File and Plant Master File
• Wholesale License for Indian distributor
• Company Constitution and Importer’s PAN and GST details

Timeline and Processing Duration

Government Fees and Costs

• MD5 License: ₹5,000 per application + ₹500 per product
• MD13 Test License: No separate fees; included in process
• MD15 Import License: Fees vary by class; for Class B devices, approximately ₹2,000 per site + ₹1,000 per product

Additional costs to factor in include product testing fees (varies by lab and tests), notified body audit charges, and consultancy fees if you seek expert assistance.

Common Challenges and Solutions

• Delays in Product Testing: To avoid delays, pre-select CDSCO-approved labs with faster turnaround and ensure your samples meet testing criteria.
• Incomplete Documentation: Use checklists from official sources and consult experienced professionals to avoid missing critical documents such as risk management files or quality system evidence.
• Audit Non-Conformities: Conduct internal mock audits and train your technical staff on regulatory requirements before notified body inspections.
• Query Resolution Delays: Respond promptly and comprehensively to departmental queries with supporting evidence to expedite approvals.

Expert Consultation and Support

Navigating CDSCO licensing can be complex, especially for specialized devices like Orthopaedic dental files. Our 25+ years of experience means we understand nuances—from technical documentation to audit preparation. We provide end-to-end support including dossier preparation, test lab coordination, notified body liaison, and regulatory submissions.

Getting Started with Your CDSCO License Application

1. Assess your device risk classification and confirm it is Class B using the Medical Device Classification tool.
2. Prepare your Test License application (Form MD13) and initiate product testing at approved laboratories.
3. Develop comprehensive Device and Plant Master Files using our detailed guides.
4. Submit your MD5 manufacturing license application (Form MD3) through the CDSCO MD Online Portal.
5. Coordinate with a notified body for the required audit and prepare your facility accordingly.
6. Respond promptly to any queries and track your application status regularly.

Taking these proactive steps ensures a smoother pathway to market entry for your Orthopaedic dental files. Partner with seasoned experts to optimize your compliance strategy and accelerate your CDSCO licensing journey.

For personalized assistance, documentation templates, and audit readiness checklists, contact our regulatory consultancy today.