CDSCO License for Transobturator needle, reusable

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

Navigating the Indian regulatory landscape for medical devices can be complex, especially for specialized surgical instruments such as the reusable Transobturator needle. This device, classified as Class B under CDSCO guidelines, plays a critical role in urology by facilitating the surgical treatment of stress urinary incontinence (SUI) using the transobturator approach. With over 25 years of regulatory consultancy experience and having supported 500+ companies, we provide you with a detailed, actionable roadmap tailored to this device’s licensing requirements.

CDSCO Regulatory Framework for Reusable Transobturator Needle

The Central Drugs Standard Control Organization (CDSCO) regulates all medical devices in India. The Transobturator needle, being a manual surgical instrument intended for urological applications, falls under Class B — indicating low to moderate risk. This classification mandates compliance with CDSCO’s MD5 manufacturing license framework, governed at the State Licensing Authority level.

The primary legislation governing this device is the Medical Device Rules (MDR) 2017, which classify devices based on risk and intended use. The device’s official notification under File No. 29/Misc./03/2020-DC (145), dated 23.8.2021, confirms its regulatory pathway.

Risk Classification and License Requirements

According to CDSCO, Class B devices like the reusable Transobturator needle require an MD5 license (application via Form MD3). This license authorizes manufacturing within India and ensures adherence to safety, quality, and efficacy standards.

Key points:

• License Type: MD5 (Manufacturing License for Class A and B devices)
• Licensing Authority: State Licensing Authority
• Total Timeline: Approximately 3-4 months (including test license)
• Cost: Rs. 5,000 per application + Rs. 500 per product

For importers, the MD15 import license applies, but this guide focuses on domestic manufacturing.

Manufacturing License Process (MD5) for Transobturator Needle

1. Test License (Form MD13): Before applying for MD5, obtain a test license which takes about 1.5-2 months. This permits product testing in approved laboratories.
2. Product Testing: The reusable Transobturator needle must be tested in CDSCO-approved testing labs to validate safety and performance. Refer to the list of testing laboratories for selection.
3. Document Preparation: Assemble required documents including Device Master File (DMF), Plant Master File (PMF), Quality Management System (QMS) records, and risk management files.
4. Application Submission: Submit the MD5 application (Form MD3) via the CDSCO MD Online Portal.
5. Audit by Notified Body: A notified body will conduct an on-site audit of your manufacturing facility. Check the list of notified bodies to select an authorized auditor.
6. Query Resolution: Address any queries or deficiencies raised by the licensing authority or auditor promptly.
7. License Grant: Upon satisfactory compliance, the State Licensing Authority issues the MD5 manufacturing license.

Manufacturing License Documents Required

For the reusable Transobturator needle, ensure the following documents are meticulously prepared:

• Company Constitution: Proof of legal entity (e.g., incorporation certificate)
• Premises Proof: Ownership or lease agreement of manufacturing site
• Technical Staff Credentials: Details and qualifications of personnel involved in manufacturing
• Fire NOC & Pollution NOC: Obtained from respective local authorities
• Device Master File (DMF): Detailed product specifications, design, and manufacturing process. Our Device Master File guide explains preparation best practices.
• Plant Master File (PMF): Overview of manufacturing facility and quality systems. See our Plant Master File guide for templates.
• Essential Principles Compliance Checklist: Demonstrates adherence to CDSCO’s safety and performance requirements
• Risk Management File: Risk analysis and mitigation strategies tailored to the device. Learn more about risk management implementation.
• Test Reports: From CDSCO-approved labs validating product safety and functionality
• Labels and Instructions for Use (IFU): Compliant with MDR standards
• Quality Management System (QMS) Documents: ISO 13485 certification and internal SOPs

Import License Process (MD15) for Reference

While this guide primarily addresses manufacturers, importers of the reusable Transobturator needle must apply for an MD15 license via Form MD14. This process is governed by the Central Licensing Authority and typically takes 5-6 months. Key documents include the manufacturing license from the country of origin, free sale certificate, ISO 13485:2016, CE certificate, DMF, PMF, wholesale license, and company constitution.

Timeline and Processing Duration

Government Fees and Costs

• Test License (MD13): No separate fee; included in application process
• MD5 License Application: Rs. 5,000 per application
• Product Fee: Rs. 500 per product (for the Transobturator needle)
• Audit and Testing Costs: Variable; notified body audits typically range from Rs. 50,000 to Rs. 1,00,000 depending on scope

Common Challenges and Practical Solutions

• Delayed Test Reports: Coordinate early with CDSCO-approved testing labs to secure appointment slots. Maintain clear communication to avoid bottlenecks.
• Incomplete Documentation: Use comprehensive checklists for DMF, PMF, and risk files. Engage experienced consultants to review before submission.
• Audit Non-Compliance: Conduct internal mock audits prior to notified body visits. Address facility and process gaps proactively.
• Query Management: Respond promptly and thoroughly to CDSCO queries. Attach supporting documents to avoid prolonged processing.

Expert Consultation and Support

Our extensive experience helping over 500 companies navigate CDSCO licensing ensures you receive tailored support—from documentation preparation and audit readiness to query handling and post-license compliance. We recommend leveraging expert advice, particularly for technical document compilation and regulatory strategy.

Getting Started with Your CDSCO License Application

1. Verify Device Classification: Confirm your device is Class B via CDSCO guidelines or by consulting our detailed medical device classification resource.
2. Initiate Test License (MD13): Apply promptly via the CDSCO MD Online Portal.
3. Engage Testing Laboratories: Book testing at CDSCO-approved labs early to align with your project timelines.
4. Prepare Technical Documentation: Utilize our comprehensive guides to compile your DMF, PMF, and risk management files.
5. Select Notified Body: Choose an auditor from the notified bodies list and schedule your audit.
6. Submit MD5 Application: Complete Form MD3 and upload all required documents through the online portal.
7. Plan for Audit and Response: Prepare your facility and quality systems for the audit, and establish a team to address queries quickly.

By following these actionable steps and leveraging expert support, manufacturers of reusable Transobturator needles can efficiently obtain their CDSCO MD5 manufacturing license, ensuring compliance and market readiness in India’s evolving medical device sector.