CDSCO License for Suprapubic needle, surgical, reusable

Comprehensive Guide to CDSCO Licensing for Suprapubic Needle, Surgical, Reusable (Class B Medical Device)

As specialists with over 25 years of experience in medical device regulatory affairs, we have successfully supported more than 500 companies in obtaining their CDSCO licenses. This guide focuses specifically on the regulatory requirements, processes, and practical tips to secure your manufacturing or import license for the suprapubic needle, surgical, reusable—a Class B urological device used for suprapubic access during female stress urinary incontinence (SUI) treatment.

Understanding the Suprapubic Needle and Its Regulatory Importance

The suprapubic needle is a critical hand-held surgical instrument characterized by a sharp pyramidal or conical tip designed for percutaneous puncture of the lower abdominal wall. Its precise function enables safe suprapubic access, which is essential for surgical procedures like positioning slings for SUI associated with bladder prolapse.

Given its invasive nature and potential patient safety implications, the device is classified as Class B under the Indian CDSCO framework, which entails moderate risk and requires strict compliance with regulatory standards to ensure efficacy, sterility, and safety.

CDSCO Regulatory Framework for Suprapubic Needle (Class B Device)

The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India. For Class B devices such as the suprapubic needle, the Manufacturing License (MD5) is issued by the respective State Licensing Authority. Import licenses fall under the Central Licensing Authority’s purview.

The device is notified under File No. 29/Misc./03/2020-DC (145) dated 23.8.2021, mandating compliance with the latest regulatory updates.

Risk Classification and License Requirements for Class B Devices

• Risk Class: B (Low to moderate risk)
• Regulatory Route for Manufacturing: MD5 License (Form MD3 application)
• Authority: State Licensing Authority
• Typical Timeline: 3-4 months (including test license and audit)
• Government Fees: ₹5,000 application fee + ₹500 per product

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

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

1. Test License Application (Form MD13): Initially, apply for a test license valid for 12 months. This process typically takes 1.5 to 2 months.
2. Product Testing: Submit your suprapubic needles to government-approved testing laboratories for quality and safety testing. A list of approved testing laboratories is available on the CDSCO portal.
3. Documentation Preparation: Compile essential documents including Device Master File, Plant Master File, Risk Management File, and QMS documentation.
4. Application Submission: Submit the manufacturing license application on Form MD3 through the CDSCO MD Online Portal.
5. Audit by Notified Body: Your manufacturing site will undergo an audit by a notified body. Refer to the list of notified bodies for approved auditors.
6. Query Resolution: Address any queries raised by the licensing authority or audit team promptly.
7. License Grant: Upon successful evaluation, the MD5 license will be granted, allowing full-scale manufacturing.

Manufacturing License Documents Required for Suprapubic Needle

• Company Constitution (e.g., MOA, AOA)
• Proof of ownership or lease of manufacturing premises
• Technical staff qualifications and experience certificates
• Fire NOC and Pollution Control Board NOC
• Device Master File detailing product specifications (Device Master File Guide)
• Plant Master File describing manufacturing processes (Plant Master File Guide)
• Essential Principles Checklist ensuring compliance with Indian standards
• Risk Management File (Risk Management Reference)
• Test Reports from government-approved laboratories
• Product labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, preferably ISO 13485 certified

Import License Process for Suprapubic Needle (MD15 License)

Importers must obtain an MD15 license from the Central Licensing Authority. The process includes:

1. Document Preparation: Gather all required documents such as a valid manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, Device and Plant Master Files, wholesale license, and company constitution.
2. Application Submission: Apply on Form MD14 via the CDSCO MD Online Portal.
3. Query Resolution: Respond to any clarifications requested by CDSCO.
4. License Issuance: License is granted on Form MD15, typically within 5-6 months.

Import License Documents Required

• Valid Manufacturing License from country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale license
• Company Constitution

Timeline and Processing Duration

Government Fees and Costs for Suprapubic Needle Licensing

• MD5 Manufacturing License: ₹5,000 per application + ₹500 per product
• MD15 Import License: Fees vary by class; for Class B devices typically:
  • ₹2,000 per site
  • ₹1,000 per product

Common Challenges and Practical Solutions

• Delayed Testing Results: Government labs may have backlogs; consider scheduling well in advance and verify lab accreditation.
• Incomplete Documentation: Use comprehensive checklists and our expert-reviewed templates for Device and Plant Master Files.
• Audit Non-compliance: Prepare thoroughly using notified body audit checklists and conduct internal mock audits.
• Query Resolution Delays: Respond promptly and seek professional help to avoid prolonged licensing timelines.

Expert Consultation and Support

With decades of regulatory expertise, we provide tailored consultation, document preparation assistance, and liaison with CDSCO authorities to ensure your suprapubic needle licensing journey is smooth and compliant. Our support includes audit readiness, risk management implementation, and post-license compliance guidance.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm your device is Class B to follow the MD5 pathway.
2. Set Up QMS: Establish or upgrade your Quality Management System aligned with ISO 13485.
3. Prepare Documentation: Begin assembling Device Master File and Plant Master File with precise and validated data.
4. Apply for Test License: Submit Form MD13 through the CDSCO MD Online Portal and schedule product testing.
5. Plan for Audit: Identify a notified body early to align timelines and expectations.

By initiating these steps with expert guidance, you position your reusable suprapubic needle for timely regulatory approval and successful market entry in India’s dynamic urology device segment.

For detailed insights on the MD5 license process, see our MD5 License Guide.