CDSCO License for Anaesthetic Conduction Needle

Comprehensive Guide to CDSCO Licensing for Anaesthetic Conduction Needles (Class B)

Anaesthetic conduction needles play a vital role in regional anesthesia by delivering local anesthetics safely and effectively. Categorized under disposable hypodermic needles and classified as Class B medical devices by CDSCO, these needles require strict regulatory compliance to ensure patient safety and market access in India. With over 25 years of experience and having assisted 500+ companies in obtaining their CDSCO licenses, we provide a detailed walkthrough for manufacturers and importers aiming to enter the Indian market with Anaesthetic Conduction Needles.

CDSCO Regulatory Framework for Anaesthetic Conduction Needles

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Drugs and Cosmetics Act, 1940, and its amendments. Anaesthetic conduction needles fall under Class B (low-moderate risk) as per the notification [29/Misc/3/2017-DC (292)] dated 06.06.2018, which governs disposable hypodermic needles.

Manufacturers of Class B devices must obtain an MD5 manufacturing license from the respective State Licensing Authority before commencing production. Importers require an MD15 import license granted by the Central Licensing Authority. All applications are processed through the CDSCO MD Online Portal.

Risk Classification and License Requirements for Anaesthetic Conduction Needles

• Risk Class: B (Low to moderate risk)
• License for Manufacturing: MD5 License (Form MD3)
• Authority: State Licensing Authority
• License for Import: MD15 License (Form MD14)
• Authority: Central Licensing Authority

This classification mandates adherence to quality, safety, and performance standards aligned with the Essential Principles checklist and Good Manufacturing Practices (GMP).

Manufacturing License Process for Anaesthetic Conduction Needles (MD5)

1. Test License (Form MD13):

   • Apply for a test license as the first step, valid for 3 months.
   • Processing time: 1.5 to 2 months.

2. Product Testing:

   • Conduct product testing at CDSCO-approved testing laboratories. Refer to the list of testing laboratories.
   • Testing validates compliance with Indian standards and safety requirements.

3. Document Preparation:

   • Prepare all mandatory documents including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documentation.

4. License Application:

   • Submit the manufacturing license application on Form MD3 via the CDSCO MD Online Portal.

5. Audit by Notified Body:

   • Undergo an audit conducted by a notified body from the official Notified Bodies List to verify compliance.

6. Query Resolution:

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

7. License Grant:

   • Upon satisfactory review, the State Licensing Authority grants the MD5 license (Form MD5).

For an in-depth understanding, consult our MD5 License Guide.

Manufacturing License Documents Required for Anaesthetic Conduction Needles

• Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
• Proof of ownership/lease agreement of manufacturing premises
• Technical staff qualifications and experience details
• Fire NOC and Pollution Control Board NOC
• Device Master File detailing design, manufacturing process, and specifications (Device Master File Guide)
• Plant Master File outlining facility details (Plant Master File Guide)
• Essential Principles Compliance Checklist
• Risk Management File prepared as per ISO 14971 (Risk Management)
• Test Reports from CDSCO-approved laboratories
• Product labeling and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, preferably ISO 13485:2016 certification

Preparation of these documents with attention to detail significantly reduces processing delays.

Import License Process for Anaesthetic Conduction Needles (MD15)

1. Document Preparation:

   • Compile required documentation including manufacturing license, Free Sale Certificate from country of origin, ISO 13485:2016, CE Certificate, and other technical files.

2. Application Submission:

   • Submit the MD15 application (Form MD14) through the CDSCO MD Online Portal.

3. Review and Query Resolution:

   • CDSCO reviews the application and may raise queries; timely responses are critical.

4. License Grant:

   • Upon satisfactory review, the Central Licensing Authority grants the import license (Form MD15).

Refer to our detailed Import License Guide for comprehensive assistance.

Import License Documents Required for Anaesthetic Conduction Needles

• Valid Manufacturing License of the foreign manufacturer
• Free Sale Certificate from the country of origin
• ISO 13485:2016 certification
• CE Certificate or equivalent regulatory approval
• Device Master File and Plant Master File
• Wholesale License for the importer
• Company Constitution

Ensuring completeness and authenticity of these documents expedites licensing.

Timeline and Processing Duration

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

  • Test license (MD13): 1.5 to 2 months
  • Product testing: 2 to 4 weeks
  • Audit and application processing: 1 to 1.5 months

• Import License (MD15): Approximately 5 to 6 months.

Proactive planning and early engagement with notified bodies and testing labs can help adhere to these timelines.

Government Fees and Costs

• MD5 License:

  • Application fee: Rs. 5,000 per application
  • Per product fee: Rs. 500

• MD15 Import License:

  • For Class B devices, fees are approximately $2,000 per site and$1,000 per product

Additional costs include product testing fees, audit fees charged by notified bodies, and consultancy fees if applicable.

Common Challenges and Solutions

• Delayed Test Reports: Coordinate closely with CDSCO-approved testing laboratories to schedule timely testing. Use the Testing Laboratories List for selection.

• Incomplete Documentation: Utilize checklists and expert guidance to ensure all documents, especially Device and Plant Master Files, are complete and comply with CDSCO requirements.

• Audit Non-compliance: Engage experienced notified bodies from the official list early and prepare your quality systems thoroughly to pass audits.

• Query Resolution Delays: Assign dedicated teams to respond promptly and accurately to CDSCO queries.

Expert Consultation and Support

Navigating CDSCO licensing can be complex. Our proven track record with over 500 successful companies means we understand the nuances involved. We offer tailored consulting services including:

• Comprehensive gap analysis for your technical documentation
• Coordination with notified bodies and testing laboratories
• End-to-end application filing and follow-ups
• Training for your technical and regulatory teams

Partnering with experts reduces risk, accelerates approval, and ensures compliance.

Getting Started with Your CDSCO License Application for Anaesthetic Conduction Needles

1. Assess Your Product Classification: Confirm the Class B designation and applicable notifications.

2. Prepare Initial Documentation: Draft your Device Master File and Plant Master File using our guides.

3. Apply for Test License (MD13): Submit your test license application via the CDSCO MD Online Portal.

4. Schedule Product Testing: Arrange testing at CDSCO-approved labs early to avoid delays.

5. Engage a Notified Body: Select and appoint a notified body for the mandatory audit.

6. Complete License Application: Assemble all documents and apply for the MD5 manufacturing license.

7. Respond to Queries Promptly: Maintain communication with CDSCO and the notified body.

8. Receive License and Commence Manufacturing: Upon approval, begin operations compliant with Indian regulations.

Starting early with a detailed roadmap and expert support maximizes your chances of a smooth and timely CDSCO license grant for your Anaesthetic Conduction Needles.

For tailored assistance, contact our regulatory experts who specialize in medical device licensing in India.