CDSCO License for Dental surgical procedure kit, medicated, single-use
Medical Device Information
Intended Use
A collection of various sterile dental instruments, dressings, pharmaceuticals and the necessary materials used to perform a dental surgical procedure.
Comprehensive Guide to CDSCO Licensing for Dental Surgical Procedure Kits (Medicated, Single-Use)
Navigating the regulatory landscape for medical devices in India requires detailed knowledge and experience, especially for specialized products like dental surgical procedure kits. These kits, classified as Class C devices, combine sterile dental instruments, dressings, pharmaceuticals, and essential materials for dental surgeries. Given their critical role in patient safety, obtaining a valid CDSCO license is mandatory before manufacturing or importing in India.
With over 25 years of expertise assisting 500+ companies, we provide you with an in-depth, practical roadmap to secure your CDSCO license efficiently.
CDSCO Regulatory Framework for Dental Surgical Procedure Kits
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Ministry of Health and Family Welfare. The regulatory framework for dental surgical procedure kits comes under the Medical Device Rules, 2017, which classifies devices based on risk, intended use, and complexity.
For your dental surgical kits, notified under Notification 29/Misc./03/2020-DC (140) Part-5 dated 10.10.2022, compliance with the Medical Device Rules is mandatory to ensure safety and efficacy.
Risk Classification and License Requirements for Class C Devices
Dental surgical procedure kits fall under Class C, indicating a moderate to high risk due to their invasive nature and inclusion of pharmaceuticals.
- License Type: MD9 Manufacturing License
- Issuing Authority: Central Licensing Authority (CDSCO Headquarters)
- Application Form: MD7
Class C devices require rigorous testing, documentation, and an audit by CDSCO inspectors before license approval. This ensures the highest standards in quality and patient safety.
Manufacturing License Process (MD9) for Dental Surgical Kits
The MD9 license process for Class C devices involves several critical steps:
- Test License (Form MD13): Initial approval to conduct testing of your product. This step typically takes 1.5 to 2 months.
- Product Testing: Conduct product testing at CDSCO-approved labs to verify compliance with Indian standards.
- Document Preparation: Compile necessary documents, including Device Master File (DMF), Plant Master File (PMF), risk management files, and quality system documentation.
- Application Submission: Submit the MD9 application (Form MD7) via the CDSCO MD Online Portal.
- Audit and Inspection: CDSCO inspectors conduct a detailed audit of your manufacturing facility and documents.
- Queries Resolution: Address any queries or observations raised by CDSCO or the audit team promptly.
- License Grant: Upon satisfactory review, the MD9 license is granted, allowing commercial manufacturing.
We recommend early engagement with a notified body and CDSCO-approved testing labs to streamline the testing and audit phases. Refer to the list of notified bodies and testing laboratories for selecting reliable partners.
Manufacturing License Documents Required for MD9
For dental surgical procedure kits, meticulous documentation is vital. Typical documentation includes:
- Company Constitution (Incorporation Certificate, MOA/AOA)
- Proof of ownership or lease agreement of manufacturing premises
- Details and qualifications of technical and management staff
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF) detailing design, specifications, and manufacturing process (see our DMF guide)
- Plant Master File (PMF) describing manufacturing facility and quality controls (PMF guide here)
- Essential Principles Checklist aligned with Medical Device Rules
- Risk Management File demonstrating hazard analysis and mitigation (risk management insights)
- Test reports from CDSCO-approved laboratories
- Labels, Instructions for Use (IFU), and packaging details
- Quality Management System (QMS) documents, preferably ISO 13485:2016 certification
Organizing these documents systematically will reduce review time and improve compliance.
Import License Process (MD15) for Dental Surgical Kits
If you intend to import your dental surgical kits, the MD15 Import License is mandatory. The process involves:
- Application Form: MD14
- Authority: Central Licensing Authority
- Process: Document preparation → Application submission on CDSCO MD Online Portal → Queries resolution → License grant
Required documents include:
- Valid manufacturing license from the country of origin
- Free Sale Certificate
- ISO 13485:2016 and CE Certificate
- Device Master File and Plant Master File
- Wholesale license in India
- Company Constitution
The entire import license process generally requires 5-6 months.
Timeline and Processing Duration for MD9 License
| Step | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 1 to 1.5 months |
| Document Preparation | 2 – 3 weeks |
| Application Submission & Audit | 1.5 – 2 months |
| Query Resolution & License Grant | 2 – 4 weeks |
Total duration: Approximately 4-5 months
Planning ahead and preparing documentation in parallel with testing can significantly reduce delays.
Government Fees and Costs
The fee structure for MD9 license (Class C devices) is as follows:
- Application Fee: ₹50,000
- Per Product Fee: ₹1,000
Additional costs to consider:
- Testing fees at CDSCO-approved laboratories
- Audit fees charged by notified bodies (if applicable)
- Consultancy and document preparation services
Budgeting for these expenses upfront helps avoid last-minute financial surprises.
Common Challenges and Practical Solutions
1. Prolonged Testing Delays: Testing labs often face backlogs. Solution: Book testing slots early and choose labs with shorter turnaround times.
2. Incomplete Documentation: Missing or inconsistent documents can stall your application. Solution: Use comprehensive checklists and consult regulatory experts.
3. Audit Non-Compliance: Manufacturing facilities may not meet audit standards initially. Solution: Pre-audit self-inspections and implement corrective actions.
4. Query Management: Delayed or inadequate responses to CDSCO queries cause processing delays. Solution: Assign dedicated teams to respond promptly with evidence-based answers.
Expert Consultation and Support
With our extensive experience guiding over 500 companies through the CDSCO licensing maze, we offer:
- Tailored regulatory strategy for your dental surgical kits
- End-to-end document preparation and review
- Coordination with notified bodies and testing labs
- Training for staff on audit readiness
- Post-license compliance support
Our proven track record ensures your license application proceeds smoothly, minimizing time and cost.
Getting Started with Your CDSCO License Application
To embark on your CDSCO licensing journey for dental surgical procedure kits:
- Register on the CDSCO MD Online Portal: This is mandatory for all applications.
- Initiate Test License Application (MD13): Prepare basic company and product information.
- Engage CDSCO-Approved Testing Laboratories: Schedule product testing early.
- Begin Document Compilation: Utilize our Device Master File guide and Plant Master File guide to organize your files.
- Plan for Audit: Conduct internal audits to ensure compliance.
Taking these concrete steps will set a robust foundation for timely license approval and successful market entry.
For personalized assistance and to leverage our 25+ years of regulatory expertise, contact us today and transform your dental surgical kit licensing process from complex to seamless.
