CDSCO License for Dental anaesthesia syringe, reusable

Comprehensive Guide to CDSCO Licensing for Dental Anaesthesia Syringe, Reusable (Class B)

Entering the Indian medical device market with a dental anaesthesia syringe, reusable, requires navigating the regulatory landscape with precision. As a hand-held manual dental instrument designed for injecting anaesthetic agents subcutaneously or intramuscularly from prefilled cartridges (excluding the needle), this device falls under Class B risk category according to the CDSCO notification 29/Misc./03/2020-DC (140) Part-5, dated 10.10.2022.

With over 25 years of experience assisting 500+ manufacturers in securing CDSCO licenses, we understand the nuances and challenges involved in obtaining the necessary approvals efficiently and compliantly. This comprehensive guide walks you through every step, from understanding regulatory frameworks to submitting your application via the CDSCO MD Online Portal.

CDSCO Regulatory Framework for Dental Anaesthesia Syringe (Reusable)

The Central Drugs Standard Control Organization (CDSCO) regulates all medical devices in India under the Medical Device Rules, 2017 (amended). The reusable dental anaesthesia syringe is classified as a Class B device—indicating low to moderate risk. CDSCO's regulatory oversight ensures safety, quality, and efficacy before market entry.

Key Regulatory Highlights:

• Device Category: Dental
• Risk Class: B (Low-Moderate Risk)
• Relevant Notification: 29/Misc./03/2020-DC (140) Part-5
• Notification Date: 10.10.2022

This classification mandates a Manufacturing License (MD5) issued by the State Licensing Authority. For importers, an Import License (MD15) granted by the Central Licensing Authority is required.

Risk Classification and License Requirements for Class B Medical Devices

Class B devices like the reusable dental anaesthesia syringe require rigorous quality controls but involve a relatively streamlined licensing process compared to higher risk classes.

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

The process includes obtaining a Test License (MD13) initially for product testing, followed by compliance audits and documentation review.

More on Medical Device Classification can provide broader insights.

Manufacturing License Process (MD5) for Dental Anaesthesia Syringe

The MD5 license is mandatory for manufacturing Class B devices in India. Here's the detailed stepwise process:

1. Apply for Test License (Form MD13): Required to conduct mandatory product testing. The test license typically takes 1.5-2 months to be granted.

2. Product Testing: Conduct testing at CDSCO notified government-approved laboratories to validate safety and performance. Refer to the list of testing laboratories.

3. Document Preparation: Assemble all required documents, including Device Master File (DMF), Plant Master File (PMF), Quality Management System documents, Essential Principles Checklist, and Risk Management File.

4. Audit by Notified Body: The manufacturing site undergoes an audit by a CDSCO notified body. You can check the list of notified bodies authorized to conduct these audits.

5. Submission of Application (Form MD3): Submit your application for the MD5 license through the CDSCO MD Online Portal.

6. Queries and Compliance: Address any queries raised by the authority or notified body promptly.

7. Grant of License (Form MD5): Upon successful review and audit, the license is issued.

This entire process typically spans 3 to 4 months.

For an in-depth understanding, our MD5 License Guide is a valuable resource.

Manufacturing License Documents Required

For your reusable dental anaesthesia syringe, ensure the following documents are meticulously prepared:

• Company Constitution Documents (e.g., Incorporation Certificate)
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualification and Experience Documents
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing design, materials, and manufacturing process (DMF Guide)
• Plant Master File (PMF) outlining the manufacturing facility and quality systems (PMF Guide)
• Essential Principles Checklist demonstrating compliance with Indian Medical Device Rules
• Risk Management File addressing potential device risks (Risk Management Guide)
• Test Reports from CDSCO-approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documents (e.g., ISO 13485 Certification)

Accurate documentation reduces query cycles and accelerates license approval.

Import License Process (MD15) for Dental Anaesthesia Syringe

If you plan to import this Class B dental device, the Import License MD15 is mandatory.

Key Steps:

1. Document Preparation: Include manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE Certificate (if applicable), DMF, PMF, Wholesale License, and Company Constitution.

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

3. Queries Resolution: Respond promptly to any clarifications sought by CDSCO.

4. Grant of License (Form MD15): Typically takes 5-6 months from submission.

Import Licensing Fees for Class B Devices:

• $2,000 per site
• $1,000 per product

For detailed guidance, refer to our Import License Guide.

Timeline and Processing Duration

Combining test license and manufacturing license steps, expect approximately 3 to 4 months to manufacture legally.

Government Fees and Costs

For your reusable dental anaesthesia syringe (Class B):

• MD5 Manufacturing License: Rs 5,000 per application + Rs 500 per product
• Test License (MD13): Typically included in application fees
• Import License (MD15): $2,000 per site +$1,000 per product

These fees are subject to change; always verify current rates on the CDSCO MD Online Portal.

Common Challenges and Solutions

1. Delays in Product Testing: Delays at government-approved labs can extend timelines.

• Solution: Schedule testing early and consider labs with faster turnaround times.

2. Incomplete Documentation: Missing or inconsistent documents trigger multiple queries.

• Solution: Use detailed checklists and expert reviews before submission.

3. Audit Non-Compliance: Facility or process gaps can result in audit failures.

• Solution: Conduct internal pre-audits and corrective actions prior to notified body inspections.

4. Regulatory Updates: Frequent policy changes can cause confusion.

• Solution: Stay updated via CDSCO notifications and partner with experienced consultants.

Expert Consultation and Support

We bring decades of hands-on experience helping manufacturers and importers successfully navigate CDSCO licensing for Class B dental devices. Our services include:

• End-to-end license application preparation and submission
• Pre-audit readiness and mock inspections
• Device and plant master file preparation
• Risk management and QMS implementation
• Liaison with CDSCO and notified bodies

Partnering with experts can reduce your time to market and ensure compliance with minimal rework.

Getting Started with Your CDSCO License Application

Ready to launch your reusable dental anaesthesia syringe in India? Follow these practical steps:

1. Verify Device Classification: Confirm your device is Class B under CDSCO rules.
2. Initiate Product Testing: Apply for the Test License (MD13) immediately to avoid delays.
3. Prepare Documentation: Start assembling DMF, PMF, QMS, and risk files in parallel.
4. Engage a Notified Body: Schedule your manufacturing site audit early by consulting the official Notified Bodies List.
5. Submit Applications Online: Utilize the CDSCO MD Online Portal for all submissions.
6. Respond Promptly: Address any queries from CDSCO or auditors within stipulated timelines.

By following this roadmap and leveraging expert support, your dental anaesthesia syringe manufacturing or import license can be secured efficiently, enabling you to confidently enter the Indian market.

For personalized assistance or to discuss your specific case, please contact our regulatory team—your trusted partner in CDSCO compliance.