CDSCO License for Dental anaesthesia syringe, intraligamentary
Medical Device Information
Intended Use
A hand-held manual dental instrument intended to be used to inject an anaesthetic agent under pressure via the periodontal ligament or into bone through an attached sterile needle. This is a reusable device.
Comprehensive CDSCO Licensing Guide for Dental Anaesthesia Syringe, Intraligamentary (Class C Medical Device)
At our consultancy, with over 25 years of experience and support for 500+ companies, we understand the regulatory nuances involved in obtaining a CDSCO license for dental devices, specifically the Class C Dental Anaesthesia Syringe, intraligamentary. This reusable, hand-held dental instrument injects anaesthetic agents via the periodontal ligament or bone, making it a critical device within the dental category under CDSCO Notification 29/Misc./03/2020-DC (140) Part-5 dated 10.10.2022.
Navigating the CDSCO regulatory landscape efficiently requires clarity on classification, documentation, timelines, and fees. Our in-depth guide below provides actionable insights so manufacturers and importers can confidently approach the Indian market.
CDSCO Regulatory Framework for Dental Anaesthesia Syringe, Intraligamentary
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules (MDR) 2017, amended in 2020. Dental Anaesthesia Syringes fall under the dental device category with specific notifications outlining classification and requirements.
As per the Medical Device Classification, this syringe is classified as a Class C device due to its invasive nature and potential risks associated with injection into periodontal ligament or bone. Class C devices require a manufacturing license (MD9) issued by the Central Licensing Authority.
Understanding Risk Classification and License Requirements
- Device: Dental Anaesthesia Syringe, Intraligamentary
- Risk Class: C
- License Type: MD9 Manufacturing License (Form MD7)
- Authority: Central Licensing Authority (CDSCO HQ, New Delhi)
- Applicable Notification: 29/Misc./03/2020-DC (140) Part-5 dated 10.10.2022
This classification mandates a rigorous approval process, including product testing, quality management system (QMS) audits, and detailed documentation.
Manufacturing License Process for Class C Devices (MD9)
- Test License Application (Form MD13): Initial step to obtain permission to manufacture and test the device — takes approximately 1.5 to 2 months.
- Product Testing: Conducted at CDSCO-approved government laboratories. Testing validates device safety and performance.
- Documentation Preparation: Compile technical files including Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documents.
- Application for MD9 License (Form MD7): Submit the manufacturing license application through the CDSCO MD Online Portal.
- Audit by CDSCO Inspectors: Physical inspection and audit of manufacturing facility and QMS.
- Queries Resolution: Respond promptly to any queries or observations raised by CDSCO or audit teams.
- License Grant: Upon satisfactory compliance, the MD9 license is granted.
Manufacturing License Documents Required for Dental Anaesthesia Syringe
- Company Constitution (Memorandum, Articles of Association)
- Proof of Ownership or Lease of Manufacturing Premises
- Details of Technical Staff and their Qualifications
- Valid Fire and Pollution NOCs
- Device Master File (DMF): Detailed description, design, specifications, and manufacturing process (see our DMF guide)
- Plant Master File (PMF): Details about the manufacturing facility and quality control processes (learn more)
- Essential Principles Compliance Checklist
- Risk Management File demonstrating hazard analysis and mitigation (risk management insights)
- Test Reports from CDSCO-approved laboratories (lab list)
- Labels and Instructions for Use (IFU) compliant with CDSCO guidelines
- Quality Management System Documentation (ISO 13485:2016 certification is highly recommended)
Import License Process (MD15) for Dental Anaesthesia Syringe
For importers intending to bring this Class C device into India, an MD15 import license is mandatory.
- Application Form: MD14
- Authority: Central Licensing Authority
- No test license required but product testing and documentation are still essential.
- Required documents include Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016, CE certificate, DMF, PMF, Wholesale License, and Company Constitution.
- Submit the application via the CDSCO MD Online Portal.
Import License Documents Required
- Valid foreign Manufacturing License
- Free Sale Certificate from exporting country
- ISO 13485:2016 Certificate
- CE Certificate or equivalent
- Device Master File and Plant Master File
- Wholesale Drug License (if applicable)
- Constitution of Importing Company
Timeline and Processing Duration for Class C Dental Devices
| Stage | Duration Estimate |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 1 - 1.5 months |
| Document Preparation | 1 month (parallel process) |
| MD9 License Application | 1 month |
| Audit & Queries | 1 - 1.5 months |
| Total | 4 - 5 months approx |
For import licenses (MD15), expect approximately 5-6 months for the entire process.
Government Fees and Costs Breakdown
| License Type | Fee Structure |
|---|---|
| MD9 License | ₹50,000 per application + ₹1,000 per product |
| MD15 License | Class C/D: 1,500 per product |
Additional costs include fees for product testing at government-approved labs (variable), audit fees (if using notified bodies), and consultancy fees if outsourcing the process.
Common Challenges and Solutions in CDSCO Licensing
- Incomplete Documentation: Many applicants fail to provide comprehensive DMF and PMF. Solution: Follow detailed guides and consult experts early.
- Delays in Product Testing: Government labs may have backlogs. Solution: Plan testing early and consider multiple approved labs.
- Audit Non-compliance: Manufacturing facilities sometimes do not meet QMS standards. Solution: Conduct internal audits and gap assessments before CDSCO inspection.
- Query Resolution Delays: Slow responses to CDSCO queries can prolong timelines. Solution: Maintain a dedicated regulatory team to handle communication promptly.
Expert Consultation and Support
Leveraging expert consultancy with extensive CDSCO experience can significantly smooth the licensing journey. We assist with:
- Gap analysis of existing documentation
- Preparation of DMF and PMF compliant files
- Coordination with notified bodies and testing laboratories
- Application filing and follow-up on the CDSCO MD Online Portal
- Pre-audit readiness and mock inspections
Our hands-on approach has helped over 500 companies achieve timely approvals for Class C medical devices, including dental syringes.
Getting Started with Your CDSCO License Application for Dental Anaesthesia Syringe
- Classify your device precisely and confirm Class C designation using official CDSCO notifications.
- Prepare your Test License application (Form MD13) to begin manufacturing and testing legally.
- Identify a CDSCO-approved testing laboratory early to schedule product testing (testing labs list).
- Compile your Device and Plant Master Files thoroughly. Utilize our DMF and PMF guides and https://pharmadocx.com/easily-create-medical-device-plant-master-file/ for best practices.
- Implement a robust Risk Management system aligned with ISO standards to address safety concerns (risk management resource).
- Submit all applications via the official CDSCO MD Online Portal to ensure smooth processing.
- Engage with a notified body or CDSCO auditors for your mandatory facility audits and prepare to respond to any observations promptly.
By following these practical steps and leveraging decades of regulatory expertise, your journey to obtain the MD9 manufacturing license for the Dental Anaesthesia Syringe will be streamlined, enabling timely market entry in India.
For tailored consultancy and end-to-end support, reach out to our regulatory experts who specialize in dental medical devices and Class C licensing requirements.
