CDSCO License for Angiographic Needle

Comprehensive Guide to CDSCO Licensing for Angiographic Needles (Class B Medical Device)

As seasoned regulatory consultants with over 25 years of experience and having assisted more than 500 companies in successfully navigating the CDSCO licensing landscape, we understand the critical importance of obtaining the correct license for your medical device. The Angiographic Needle, classified as a Class B disposable hypodermic needle under CDSCO regulations, requires a systematic approach to compliance to ensure timely market entry in India.

Understanding the Angiographic Needle and Its Regulatory Importance

The Angiographic Needle features a unique hub design with an ergonomic feel and a black triangle indicator to orient the bevel, making it a critical tool for precise vascular access during angiographic procedures. Given its invasive nature, CDSCO classifies it as a Class B device, which demands adherence to specific regulatory frameworks to assure patient safety and device efficacy.

CDSCO Regulatory Framework for Angiographic Needles

Under the Medical Device Rules, 2017, disposable hypodermic needles like the Angiographic Needle fall into Class B due to moderate risk profiles. This classification mandates that manufacturers obtain an MD5 manufacturing license issued by the State Licensing Authority. The process involves rigorous testing, documentation, and compliance audits.

Risk Classification and License Requirements for Angiographic Needles

• Risk Class: B (Moderate risk)
• Applicable License: MD5 License (Form MD3)
• Issuing Authority: State Licensing Authority
• Total Timeline: Approximately 3 to 4 months
• License Fee: Rs 5,000 per application + Rs 500 per product

Step-by-Step Manufacturing License Process (MD5) for Angiographic Needle

1. Obtain Test License (Form MD13): This initial step allows for product testing and takes about 1.5 to 2 months. The test license is mandatory before applying for the manufacturing license.

2. Product Testing: Conduct testing at a CDSCO-approved laboratory to verify compliance with essential principles and safety standards. You can find the list of approved testing laboratories here.

3. Documentation Preparation: Assemble comprehensive documentation including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and Quality Management System (QMS) documents.

4. Application Submission: Apply for the MD5 license through the CDSCO MD Online Portal using Form MD3.

5. Audit by Notified Body: A notified body audit is scheduled post-application. Refer to the list of notified bodies for selecting an authorized auditor.

6. Resolution of Queries: Address any queries raised by the licensing authority or notified body promptly to avoid delays.

7. Grant of License: Upon successful audit and compliance, the MD5 license is granted on Form MD5, allowing legal manufacturing and marketing in India.

Essential Documents Required for MD5 License Application

• Company Constitution (e.g., Memorandum and Articles of Association)
• Proof of ownership or valid lease agreement of manufacturing premises
• Details and qualifications of technical staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing design and manufacturing processes (Our detailed Device Master File guide can help streamline this)
• Plant Master File outlining the manufacturing facility setup (Plant Master File Guide)
• Essential Principles Checklist demonstrating compliance with notified standards
• Risk Management File adhering to ISO 14971 principles (Risk Management Insights)
• Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, preferably ISO 13485 certified

Import License Process (MD15) for Angiographic Needles

While this page focuses primarily on the manufacturing license, manufacturers or importers planning to import Angiographic Needles must apply for an MD15 import license issued by the Central Licensing Authority. The process generally takes 5 to 6 months and requires extensive documentation, including manufacturing licenses from the country of origin, free sale certificates, ISO and CE certifications, among others. For detailed guidance, see our Import License Guide.

Timelines and Processing Duration

Proactively managing each step and anticipating potential queries can help meet these timelines effectively.

Government Fees and Cost Structure

• Application Fee: Rs 5,000 per license application
• Product Fee: Rs 500 per product registered under the license
• Additional Costs: Testing fees at government-approved labs and audit charges by notified bodies vary and should be budgeted separately.

Common Challenges and Practical Solutions

Challenge: Delays in product testing due to lab backlogs.

Solution: Schedule testing well ahead and engage with multiple approved labs. Maintain transparent communication with labs to anticipate delays.

Challenge: Incomplete or inconsistent documentation leading to audit objections.

Solution: Utilize comprehensive checklists and leverage expert consultation to prepare Device and Plant Master Files. Our guides on Device Master File and Plant Master File are excellent resources.

Challenge: Queries during audit causing process bottlenecks.

Solution: Maintain robust documentation and QMS; respond promptly and thoroughly to all queries.

Expert Consultation and Support

Navigating the CDSCO licensing process for Class B devices like Angiographic Needles can be complex. Our expert team offers tailored support, from initial classification advice to full application preparation and audit support, ensuring compliance and accelerated approvals. We provide end-to-end consultation to mitigate risks and streamline your licensing journey.

Getting Started with Your CDSCO License Application

1. Initiate Test License Application: Begin by applying for the test license (Form MD13) on the CDSCO MD Online Portal.

2. Engage a Notified Body Early: Contact notified bodies early to schedule your audit, reducing waiting times.

3. Prepare Documentation in Parallel: While awaiting your test license, start assembling your Device Master File, Plant Master File, and Risk Management File.

4. Coordinate Testing Logistics: Identify and liaise with CDSCO-approved testing labs to schedule product testing promptly after test license approval.

5. Plan for QMS Compliance: Ensure your manufacturing facility complies with ISO 13485, as it is integral to audit success.

By proactively managing these steps, you can ensure a smooth and timely approval process for your Angiographic Needle manufacturing license. For customized assistance and detailed project planning, reach out to our regulatory experts to leverage our 25+ years of industry experience.

Embark on your CDSCO licensing journey today to bring your Angiographic Needles safely and compliantly to the Indian market.