CDSCO License for Dental anaesthesia syringe, single-use

Comprehensive Guide to CDSCO Licensing for Dental Anaesthesia Syringe (Single-Use) - Class B Medical Device

As seasoned regulatory consultants with over 25 years of experience and having successfully guided 500+ companies through the CDSCO licensing process, we understand the nuances and intricacies involved in bringing medical devices like the Dental Anaesthesia Syringe (single-use) to the Indian market. This device, a sterile, hand-held manual instrument designed for injecting anesthetic agents via single-use cartridges, is classified as a Class B device under CDSCO regulations.

Understanding the CDSCO Regulatory Framework for Dental Anaesthesia Syringes

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India to ensure safety, efficacy, and quality. The Dental Anaesthesia Syringe falls under the Dental device category, notified under 29/Misc./03/2020-DC (140) Part-5, effective from 10.10.2022. Compliance with CDSCO regulations is mandatory for manufacturing or importing this device.

Risk Classification and License Requirements for Class B Devices

According to CDSCO's classification, Class B devices are low to moderate risk medical devices. For the Dental Anaesthesia Syringe, this means manufacturers must obtain an MD5 manufacturing license, issued by the State Licensing Authority. Importers require an MD15 import license from the Central Licensing Authority.

• Manufacturing License: MD5 License (Form MD3 application) via State Authority
• Import License: MD15 License (Form MD14 application) via Central Authority

For a detailed understanding of device classification, refer to our Medical Device Classification guide.

Step-by-Step Manufacturing License Process (MD5) for Dental Anaesthesia Syringe

1. Test License Application (Form MD13):

   • Required before manufacturing begins.
   • Processing time: 1.5 to 2 months.
   • Enables product testing in government-approved labs.

2. Product Testing:

   • Conduct tests on the Dental Anaesthesia Syringe at CDSCO-approved laboratories. Check the list of testing laboratories.

3. Document Preparation:

   • Prepare a comprehensive dossier including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and Quality Management System (QMS) documents.

4. License Application Submission:

   • Submit application on the CDSCO MD Online Portal using Form MD3.

5. Audit by Notified Body:

   • The notified body conducts a facility and quality system audit.
   • Refer to the list of notified bodies for audit assignments.

6. Query Resolution:

   • Address any queries raised by the CDSCO or notified body promptly.

7. Grant of MD5 License:

   • Upon satisfactory review and audit, the license is granted on Form MD5.

Essential Documents Required for MD5 License Application

• Company Constitution and Incorporation Certificate
• Proof of Premises Ownership or Lease Agreement
• Details of Qualified Technical Staff (e.g., Biomedical Engineer, Quality Manager)
• Fire NOC and Pollution Control Board NOC
• Device Master File outlining design, manufacturing process, and specifications. Our Device Master File guide can assist you.
• Plant Master File detailing manufacturing site and equipment. Learn more in our Plant Master File guide.
• Essential Principles Compliance Checklist
• Risk Management File demonstrating hazard analysis and mitigation
• Test Reports from CDSCO-approved laboratories
• Product labels and Instructions for Use (IFU)
• Quality Management System documents (ISO 13485:2016 preferred)

Import License Process (MD15) for Dental Anaesthesia Syringe

For companies importing the device into India, the MD15 license is mandatory and granted by the Central Licensing Authority. The process involves:

1. Document Compilation:

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

2. Application Submission:

   • Apply through the CDSCO MD Online Portal using Form MD14.

3. Query Management:

   • Respond to CDSCO queries within stipulated timelines.

4. Grant of Import License:

   • Upon satisfactory evaluation, the MD15 license is issued.

Timeline and Processing Duration

Manufacturing License (MD5): Approximately 3-4 months total.

• Test License (MD13): 1.5-2 months
• Product Testing: 2-3 weeks
• Audit and Review: 1-1.5 months

Import License (MD15): Approximately 5-6 months.

Timely and complete submissions greatly influence adherence to these timelines.

Government Fees and Costs

*For MD15 Import License, fees depend on device class and number of products. Class B devices typically incur around $2000 for site and$1000 per product.

Payment is made online through the CDSCO portal during application.

Common Challenges and Practical Solutions

• Incomplete Documentation: Ensure thorough preparation using our comprehensive checklists to avoid application rejection.
• Delayed Testing: Plan ahead and schedule testing in advance with notified testing labs.
• Audit Non-Compliance: Implement a robust QMS and pre-audit self-assessments to ensure readiness.
• Unclear Query Responses: Respond clearly and promptly with supporting evidence to expedite approval.

Expert Consultation and Support

With over two decades of experience and a portfolio of 500+ successful CDSCO approvals, we provide tailored consulting services:

• Gap analysis for compliance readiness
• Document preparation and review
• Audit preparedness and liaison with notified bodies
• Application submission and query resolution

Our expertise significantly reduces time-to-market and minimizes compliance risks.

Getting Started with Your CDSCO License Application

1. Determine Your Regulatory Path: Confirm your device’s classification and applicable license (MD5 for manufacturing).
2. Register on the CDSCO MD Online Portal: Start your application process by registering your company and device.
3. Compile Required Documentation: Use our detailed guides for Device and Plant Master Files.
4. Apply for Test License (MD13): Initiate product testing early to avoid delays.
5. Engage Notified Bodies and Testing Labs: Schedule audits and testing proactively.
6. Prepare for Audit: Conduct internal audits and staff training.
7. Submit Manufacturing License Application (MD5): Complete forms and upload documents.

For comprehensive support, consult our MD5 License Guide to understand each step in detail.

Embark on your CDSCO licensing journey with confidence. Our expert team is ready to assist you every step of the way to ensure your Dental Anaesthesia Syringe reaches Indian dental professionals efficiently and compliantly.