CDSCO License for Aspiration Needle

Comprehensive Guide to CDSCO Licensing for Aspiration Needle (Class B Medical Device)

Aspiration Needles, categorized under disposable hypodermic needles, are critical medical devices extensively used for laparoscopic aspiration or injection procedures. Given their invasive nature and direct interaction with patients, regulatory oversight ensures these devices meet stringent quality, safety, and performance standards before entering the Indian market.

With over 25 years of experience assisting 500+ manufacturers and importers, we provide an in-depth walkthrough of the CDSCO licensing process specifically tailored for Aspiration Needles, classified as Class B devices under CDSCO’s risk classification.

CDSCO Regulatory Framework for Aspiration Needles

The Central Drugs Standard Control Organization (CDSCO) governs the regulation of medical devices in India. Aspiration Needles fall under the notification number 29/Misc/3/2017-DC (292), dated 06.06.2018, which classifies them as Class B devices due to moderate risk involved in their use.

This classification mandates compliance with the Medical Device Rules, 2017 and requires obtaining a manufacturing license (MD5) if produced domestically or an import license (MD15) if imported.

Risk Classification and License Requirements

Aspiration Needles are Class B medical devices, indicating moderate risk. This classification primarily affects the regulatory pathway:

• Manufacturing License: MD5 License (Application Form MD3)
• Licensing Authority: State Licensing Authority
• Total Process Duration: Approximately 3-4 months
• Fees: Rs 5,000 per application + Rs 500 per product

This licensing process includes obtaining a Test License (Form MD13), product testing at CDSCO-approved laboratories, documentation, audit by notified bodies, and final license grant.

Manufacturing License Process for Aspiration Needles (MD5 License)

1. Apply for Test License (Form MD13): Initiate the process by applying for a test license on the CDSCO MD Online Portal. This allows you to legally manufacture the device for testing purposes.

2. Product Testing: Conduct product testing at CDSCO-recognized laboratories to validate compliance with essential principles and standards. Refer to the Testing Laboratories list for approved facilities.

3. Document Preparation: Assemble a robust dossier including technical, safety, and quality documentation.

4. Apply for Manufacturing License (Form MD3): Submit the manufacturing license application through the CDSCO MD Online Portal.

5. Audit by Notified Body: Undergo an audit by a notified body. Check the list of notified bodies to select an authorized auditor.

6. Respond to Queries: Address any observations or queries raised during the audit or by CDSCO.

7. License Grant: Upon satisfactory completion, the MD5 manufacturing license will be granted.

For detailed guidance, our MD5 License Guide provides step-by-step insights.

Manufacturing License Documents Required

For Aspiration Needles, the following documentation is essential:

• Company Constitution: Incorporation certificates, partnership deeds, or Articles of Association.
• Proof of Premises Ownership/Lease: Legal ownership or lease agreement of the manufacturing site.
• Technical Staff Details: Qualification and experience certificates of technical and quality personnel.
• Fire NOC & Pollution Control NOC: Compliance certificates from local authorities.
• Device Master File (DMF): Detailed design, manufacturing, and control information. Our Device Master File guide can assist in preparing this.
• Plant Master File (PMF): Infrastructure, equipment, and facility details. Refer to our Plant Master File guide.
• Essential Principles Compliance Checklist: Demonstration of adherence to CDSCO’s essential principles.
• Risk Management File: Risk analysis and mitigation strategies per ISO 14971 standards. See our Risk Management Guide.
• Test Reports: Laboratory test results validating device safety and performance.
• Labels and Instructions for Use (IFU): Samples of packaging labels and user manuals.
• Quality Management System (QMS) Documentation: ISO 13485 certification and related SOPs.

Import License Process (MD15) for Aspiration Needles

If importing Aspiration Needles into India, manufacturers must obtain an MD15 Import License from CDSCO’s Central Licensing Authority.

Key steps include:

1. Document Preparation: Compile manufacturing license, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files, Wholesale License, and company constitution.

2. Apply for Import License (Form MD14): Submit the application via the CDSCO MD Online Portal.

3. Query Resolution: Address any regulatory queries.

4. License Grant: Upon approval, receive the MD15 Import License.

Note that no test license is required for import applications. The process generally takes 5-6 months. Fees vary by risk class, with Class B devices like Aspiration Needles charged Rs 2,000 per site and Rs 1,000 per product.

For comprehensive details, consult our Import License Guide.

Timeline and Processing Duration

Adhering to timelines and proactive query management greatly accelerates approval.

Government Fees and Costs

• MD5 License Application Fee: Rs 5,000 per application
• Product Fee: Rs 500 per product
• Additional Costs:
  • Notified body audit fees (varies, approx Rs 50,000 to 1,00,000)
  • Testing laboratory charges (varies, typically Rs 20,000 to 50,000 per product)

Budgeting accurately for these expenses upfront prevents unexpected delays.

Common Challenges and Solutions

• Delayed Test License Grant: Early submission with complete documents mitigates this.
• Incomplete Documentation: Use detailed checklists and expert review to avoid rejection.
• Audit Non-Compliance: Conduct internal mock audits to ensure readiness.
• Query Backlog: Assign dedicated personnel for prompt query responses.

Our extensive experience has enabled us to develop tailored solutions for these pain points, ensuring smooth approvals.

Expert Consultation and Support

Navigating CDSCO licensing can be complex. Our consultancy offers:

• Pre-application readiness assessments
• Customized document preparation
• Coordination with notified bodies and testing labs
• Post-approval compliance assistance

Partnering with experts reduces errors, shortens timelines, and enhances regulatory confidence.

Getting Started with Your CDSCO License Application

1. Evaluate your device classification: Confirm Aspiration Needle as Class B.
2. Register on the CDSCO MD Online Portal: Begin by creating your company profile.
3. Prepare Test License Application (Form MD13): Gather all required documents.
4. Identify suitable testing laboratories and notified bodies: Use official CDSCO lists.
5. Schedule internal audits and quality checks: Ensure compliance before external audits.
6. Submit test license application: Monitor application status regularly.
7. Plan budget and timelines: Allocate resources for fees and process durations.

Taking these practical steps will set a strong foundation for your CDSCO licensing journey.

For further assistance, feel free to contact our regulatory experts who have successfully guided over 500 medical device companies through this exact process.