CDSCO License for Dental dressing forceps, single-use
Medical Device Information
Important Notice for Class A Devices
Class A Non-sterile Non Measuring devices are exempt from MD5 and MD15 licenses. Only CDSCO registration is required as per GSR 777(E).
Intended Use
A sterile, hand-held manual dental instrument designed for grasping and holding a dental dressing during its application to a patient's oral cavity.
Comprehensive Guide to CDSCO Licensing for Dental Dressing Forceps (Single-Use, Class A)
As a trusted regulatory consultancy with over 25 years of experience assisting more than 500 medical device companies, we understand the intricacies involved in securing the right licenses for your products. Dental dressing forceps, single-use, classified as Class A under India's CDSCO framework, require meticulous attention to regulatory details to ensure compliance and timely market entry.
Understanding Your Device and Its Regulatory Importance
Dental dressing forceps are sterile, manual instruments designed to hold and apply dental dressings within the oral cavity. Classified as Class A devices due to their low risk profile, these instruments fall under the dental category as per CDSCO Notification 29/Misc./03/2020-DC (140) Part-5 dated 10.10.2022. While considered low risk, regulatory compliance remains critical to safeguard patient safety, ensure quality, and legally market within India.
CDSCO Regulatory Framework for Dental Dressing Forceps
The Central Drugs Standard Control Organization (CDSCO) regulates all medical devices in India. Your dental dressing forceps, being Class A, require a Manufacturing License under Form MD5, issued by the State Licensing Authority. This license confirms that your manufacturing facility meets all regulatory requirements, including quality management systems and product safety standards.
Risk Classification and License Requirements
- Device: Dental dressing forceps, single-use
- Risk Class: A (Low risk)
- Applicable License: MD5 Manufacturing License (Form MD3 application)
- Authority: State Licensing Authority
- Total Processing Time: Approximately 3 to 4 months
Step-by-Step Manufacturing License Process (MD5 License)
Obtain Test License (Form MD13): Before applying for the manufacturing license, you must obtain a test license, which allows product testing at government-approved laboratories. This process typically takes 1.5 to 2 months.
Product Testing: Submit your dental dressing forceps samples to CDSCO-approved testing labs. Testing ensures compliance with Indian standards and safety requirements. Refer to the list of testing laboratories for authorized centers.
Document Preparation: Compile all required documents such as Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and Quality Management System documents.
Application Submission: Submit your manufacturing license application using Form MD3 via the CDSCO MD Online Portal.
Audit by Notified Body: A notified body will conduct a factory audit to verify compliance. You can check the list of notified bodies authorized for MD5 audits.
Resolution of Queries: Address any observations or queries raised by the licensing authority or the notified body promptly.
License Grant: Upon satisfactory compliance, the State Licensing Authority will issue the MD5 manufacturing license.
Essential Documents Required for MD5 License Application
- Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
- Proof of Ownership or Tenancy of Manufacturing Premises
- Details of Technical Staff (Qualifications and Experience)
- Fire and Pollution NOCs
- Device Master File (DMF) detailing product specifications and manufacturing processes. Our Device Master File guide helps streamline this.
- Plant Master File describing the manufacturing site setup. Refer to our Plant Master File guide for preparation tips.
- Essential Principles Checklist
- Risk Management File specific to the dental dressing forceps (risk assessments, mitigation strategies). Learn more about risk management for medical devices.
- Test Reports from CDSCO-approved labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System documentation (ISO 13485:2016 compliance)
Import License Process (MD15) – When Applicable
For importers of dental dressing forceps, obtaining an MD15 import license from the Central Licensing Authority is mandatory before marketing the device in India. The process usually takes about 5 to 6 months and requires submission of documents such as manufacturing license from the country of origin, Free Sale Certificate, CE Certificate, and QMS certification.
Timeline and Processing Duration
| Step | Approximate Duration |
|---|---|
| Test License (Form MD13) | 1.5 - 2 months |
| Product Testing | 1 - 1.5 months |
| Documentation and Application | 2 - 4 weeks |
| Factory Audit & Query Resolution | 3 - 4 weeks |
| Total Time | 3 - 4 months |
Government Fees and Costs
- Application Fee: ₹5,000 per application
- Per Product Fee: ₹500 (for each dental dressing forceps variant submitted)
These fees are payable via the CDSCO MD Online Portal during application submission.
Common Challenges and Practical Solutions
Delayed Testing: Securing timely slots in government-approved labs can be challenging. Plan testing schedules well in advance and select labs with shorter turnaround times.
Incomplete Documentation: Missing or inconsistent device master files or risk management documents often cause delays. Use detailed checklists and expert reviews to ensure completeness.
Audit Non-Compliance: Poorly prepared manufacturing sites or QMS can result in audit failures. Conduct internal audits and mock inspections before the notified body visit.
Query Resolution Delays: Promptly addressing CDSCO or notified body queries is crucial. Assign dedicated regulatory personnel for quick responses.
Expert Consultation and Support
Having guided over 500 companies through CDSCO licensing, our expertise encompasses document preparation, audit readiness, and strategic regulatory planning. We offer tailored consulting services to help dental device manufacturers navigate this process efficiently, minimizing delays and ensuring compliance.
Getting Started with Your CDSCO License Application for Dental Dressing Forceps
- Assess Your Readiness: Review your manufacturing setup, technical staff qualifications, and quality systems.
- Prepare Documentation: Begin compiling your Device and Plant Master Files, along with technical and QMS records.
- Plan for Testing: Contact CDSCO-approved testing laboratories early to schedule product testing.
- Register on the CDSCO MD Online Portal: Create your account to access application forms and submit documents electronically.
- Engage a Notified Body: Identify and coordinate with a notified body for your factory audit.
For detailed guidance, visit the official CDSCO MD Online Portal and consult our MD5 License Guide.
With careful planning and expert support, obtaining your MD5 manufacturing license for dental dressing forceps can be a smooth and timely process, paving the way for successful entry into the Indian dental device market.
