CDSCO License for Aspiration and Injection Needle

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

Aspiration and Injection Needles are critical disposable hypodermic devices used predominantly in fine needle aspiration biopsies to collect tissue or fluid samples for diagnostic purposes, including ruling out conditions like cancer. Given their direct contact with body tissues and fluids, these devices fall under Class B risk classification in India. Navigating the regulatory landscape with the Central Drugs Standard Control Organisation (CDSCO) is essential to legally manufacture or import these devices in India.

With over 25 years of expertise and having supported 500+ companies in securing CDSCO licenses, we provide a detailed, step-by-step guide tailored specifically for Aspiration and Injection Needles.

CDSCO Regulatory Framework for Aspiration and Injection Needle

The CDSCO regulates medical devices in India under the Medical Device Rules (MDR) 2017, notified through Notification 29/Misc/3/2017-DC (292) dated 06.06.2018. Aspiration and Injection Needles are categorized as Disposable Hypodermic Needles, classified as Class B devices due to their moderate risk profile.

Manufacturers of Class B devices require an MD5 manufacturing license issued by the State Licensing Authority, whereas importers must obtain an MD15 import license from the Central Licensing Authority.

Risk Classification and License Requirements for Aspiration and Injection Needle

Risk Class: B (Moderate Risk)
License Type (Manufacturing): MD5 License (Form MD3 application)
Issuing Authority: State Licensing Authority
License Type (Import): MD15 License (Form MD14 application)
Issuing Authority: Central Licensing Authority

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

Manufacturing License Process for Aspiration and Injection Needle (MD5)

Step 1: Obtain Test License (Form MD13)

Before applying for the MD5 license, manufacturers must apply for a Test License on Form MD13. This license allows sample testing of the needles in CDSCO-approved laboratories.

Duration: Approximately 1.5 to 2 months
Purpose: Conduct mandatory product testing to ensure compliance with essential principles

Step 2: Product Testing

Samples must be tested in government-approved labs listed on the CDSCO Testing Laboratories page. Testing includes sterility, biocompatibility, and mechanical strength.

Step 3: Document Preparation

Prepare comprehensive documentation as per CDSCO requirements (detailed below).

Step 4: Application Submission (Form MD3)

Submit the manufacturing license application through the CDSCO MD Online Portal.

Step 5: Audit by Notified Body

An audit of manufacturing premises and quality management systems is conducted by a notified body authorized for MD5 audits. Check the list of notified bodies to select an appropriate auditor.

Step 6: Resolution of Queries

Respond promptly to any queries raised during document review or audit.

Step 7: Grant of Manufacturing License (Form MD5)

Upon successful audit and document approval, the MD5 license is granted.

Refer to our MD5 License Guide for an in-depth process overview.

Manufacturing License Documents Required for Aspiration and Injection Needle

Company Constitution Documents: Incorporation certificate, memorandum and articles of association
Proof of Ownership/Lease of Manufacturing Premises
Technical Staff Details: Qualification and experience certificates
Fire NOC and Pollution Control NOC
Device Master File (DMF): Detailed design and manufacturing process documentation Device Master File Guide
Plant Master File (PMF): Facility details and quality assurance systems Plant Master File Guide
Essential Principles Checklist: Compliance with applicable Indian standards
Risk Management File: Risk analysis and mitigation strategies Risk Management Guide
Test Reports: From CDSCO-approved laboratories
Labels and Instructions for Use (IFU)
Quality Management System (QMS) Documents: ISO 13485 certification and related SOPs

Import License Process for Aspiration and Injection Needle (MD15)

Step 1: Document Compilation

Prepare all required documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, DMF, PMF, wholesale license, and company constitution.

Step 2: Application Submission

Apply for the MD15 import license on the CDSCO MD Online Portal.

Step 3: Query Resolution

Address any queries from the CDSCO promptly to avoid delays.

Step 4: Grant of Import License (Form MD15)

The license is granted upon successful document evaluation.

For a detailed walkthrough, see our Import License Guide.

Import License Documents Required for Aspiration and Injection Needle

Valid Manufacturing License from Country of Origin
Free Sale Certificate
ISO 13485:2016 Certificate
CE Certificate (if applicable)
Device Master File
Plant Master File
Wholesale License
Company Constitution Documents

Timeline and Processing Duration

License Type	Process Duration
MD5 Manufacturing	3 - 4 months
MD13 Test License	1.5 - 2 months
MD15 Import License	5 - 6 months

Typically, the manufacturing license process includes obtaining the test license, product testing, document submission, audit, and query resolution. For import licenses, only document evaluation and query resolution are required.

Government Fees and Costs

MD5 Manufacturing License (Class B Device)

Application Fee: Rs 5,000 per application
Per Product Fee: Rs 500 per product

MD15 Import License

Site Fee for Class B: Approximately $2,000
Per Product Fee for Class B: Approximately $1,000

Additional costs may include testing fees at government-approved labs and audit fees charged by notified bodies. Planning your budget accordingly helps avoid last-minute financial bottlenecks.

Common Challenges and Solutions

Challenge: Delays in product testing due to limited slots at approved laboratories.
- Solution: Schedule testing early during the test license period and consider multiple approved labs.
Challenge: Non-compliance with essential principles during audit.
- Solution: Conduct internal pre-audits and implement robust Quality Management Systems.
Challenge: Incomplete documentation leading to repeated queries.
- Solution: Use checklists aligned with CDSCO requirements and seek expert review before submission.
Challenge: Confusion regarding classification and appropriate license type.
- Solution: Refer to official classification guidelines and consult with experienced regulatory experts.

Expert Consultation and Support

Navigating the CDSCO licensing process for Aspiration and Injection Needles can be complex. Our 25+ years of experience and successful track record with over 500 companies empower us to:

Provide tailored regulatory strategies
Assist in document preparation including DMF and PMF
Coordinate with notified bodies and testing labs
Facilitate audit readiness and query management
Ensure timely license grant to accelerate your market entry

Getting Started with Your CDSCO License Application for Aspiration and Injection Needle

Verify Device Classification: Confirm Class B status using official resources.
Register on CDSCO MD Online Portal: Access the portal at https://cdscomdonline.gov.in/.
Prepare Test License Application: Compile necessary documents for Form MD13.
Identify Approved Testing Labs: Choose a suitable lab from the CDSCO Testing Laboratories list.
Develop Comprehensive Documentation: Use our guides on Device Master File and Plant Master File.
Schedule Audit with Notified Body: Select from the list of notified bodies early to avoid delays.
Submit Applications and Monitor Progress: Respond promptly to any CDSCO queries.

By following these practical steps, you position your Aspiration and Injection Needle product for successful and compliant entry into the Indian medical device market.

For personalized assistance, reach out to our regulatory experts who can guide you through every stage of your CDSCO license application.