CDSCO License for Dental surgical procedure kit, medicated, reusable

Comprehensive Guide to CDSCO Licensing for Dental Surgical Procedure Kits (Class C)

As seasoned regulatory consultants with over 25 years of experience and having supported 500+ companies, we understand the nuances and complexities involved in obtaining CDSCO licenses for medical devices like the Dental Surgical Procedure Kit, Medicated, Reusable. This Class C device—comprising dental instruments, dressings, pharmaceuticals, and essential materials for dental surgery—requires a rigorous regulatory pathway before entering the Indian market.

CDSCO Regulatory Framework for Dental Surgical Procedure Kits

The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India under the Medical Device Rules (MDR) 2017. Given the dental surgical kit’s risk classification as Class C (moderate to high risk), manufacturers must secure a Central Manufacturing License (MD9) and importers must obtain an Import License (MD15) from CDSCO’s Central Licensing Authority.

This regulatory structure ensures patient safety and device efficacy through strict compliance with documentation, testing, and quality management systems.

Risk Classification and License Requirements for Dental Surgical Kits

Class C devices like reusable dental surgical kits are considered moderate to high risk because they are invasive and reusable. According to the Medical Device Classification guide, this classification mandates:

• MD9 Manufacturing License (Form MD7) granted by the Central Licensing Authority
• MD15 Import License (Form MD14) for importers

This dual-licensing approach ensures thorough oversight from manufacturing to market distribution.

Manufacturing License Process for Dental Surgical Procedure Kits (MD9)

The manufacturing license process for Class C devices generally takes 4 to 5 months and involves multiple stages:

1. Test License (MD13 application): Before full license application, manufacturers must obtain a Test License to conduct product testing. This typically takes 1.5 to 2 months.

2. Product Testing: Testing must be conducted at CDSCO-approved laboratories. You can find the list of approved testing laboratories here.

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

4. License Application (MD7 form): Submit the application for the MD9 License via the CDSCO MD Online Portal.

5. Audit by CDSCO Inspectors: Post-application, CDSCO will conduct an audit of your manufacturing facility.

6. Queries Resolution: Address any queries raised by CDSCO during the review.

7. Grant of License (MD9): Once all criteria are met, the license is granted.

For detailed guidance on the MD9 process, please refer to our MD9 License Guide.

Manufacturing License Documents Required

For your Class C dental surgical kits, the following documents are essential:

• Company Constitution or Incorporation Certificate
• Proof of ownership or lease of manufacturing premises
• Details and qualifications of technical and managerial staff
• Fire NOC and Pollution Control NOC
• Device Master File (DMF) detailing device design, composition, and safety (Device Master File Guide)
• Plant Master File describing manufacturing processes and quality control (Plant Master File Guide)
• Essential Principles Checklist compliance
• Risk Management File demonstrating hazard identification and mitigation (Risk Management)
• Test Reports from CDSCO-approved labs
• Product labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, preferably ISO 13485 compliant

Import License Process for Dental Surgical Procedure Kits (MD15)

Importers seeking to bring this Class C device into India must apply for the MD15 Import License, which generally takes 5 to 6 months. The process includes:

1. Document Preparation: Gather all required documents including manufacturing license from the country of origin.

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

3. Review and Queries: CDSCO reviews the application and raises any queries.

4. Grant of Import License (MD15): Upon satisfactory review, the import license is granted.

Unlike manufacturing licenses, no test license is required for import applications.

Import License Documents Required

The documentation for import licensing includes:

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License
• Company Constitution

Detailed import licensing guidance is available in our Import License Guide.

Timeline and Processing Duration

Please note these timelines are cumulative and can vary based on document completeness and audit scheduling.

Government Fees and Costs

• MD9 License: Rs. 50,000 per application + Rs. 1,000 per product
• Test License (MD13): Included within MD9 process fees
• MD15 Import License:
  • Class C & D devices: $3,000 per site +$1,500 per product

Budgeting for testing, audits, and consultancy services is recommended to avoid surprises.

Common Challenges and Solutions

• Incomplete Documentation: Many applicants face delays due to missing or improperly prepared Device Master Files or risk management documentation. We recommend early preparation and expert review.

• Testing Delays: Selecting government-approved labs with available testing slots is critical. Utilize the CDSCO Testing Laboratories list to plan ahead.

• Audit Readiness: Facilities often fail audits due to lack of QMS implementation or poor staff training. Conduct mock audits and QMS gap assessments well before the CDSCO inspection.

• Query Resolution Delays: Rapid and comprehensive responses to CDSCO queries can significantly shorten overall licensing time.

Expert Consultation and Support

With extensive experience supporting manufacturers and importers in the dental device sector, we provide:

• Gap analysis for regulatory documentation
• Assistance with Device and Plant Master File preparation
• Coordination with notified bodies and testing labs
• Audit preparation and post-audit support
• End-to-end license application management

Our expertise has successfully navigated 500+ companies through CDSCO processes, reducing timelines and improving approval success rates.

Getting Started with Your CDSCO License Application

1. Classify Your Device: Confirm Class C classification per latest CDSCO notifications.

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

3. Apply for Test License (MD13): Submit your test license application via the CDSCO MD Online Portal.

4. Schedule Product Testing: Coordinate with an approved testing laboratory promptly.

5. Initiate License Application: Once testing is complete, apply for the MD9 Manufacturing License (Form MD7).

6. Prepare for Audit: Ensure your facility and QMS comply with CDSCO requirements.

7. Engage Expert Support: Leverage our regulatory consultancy to streamline the process and address challenges proactively.

Embarking on your CDSCO licensing journey for your dental surgical procedure kit can be complex but manageable with precise planning and expert guidance. Reach out to us to start your application confidently and compliantly.