CDSCO License for Percutaneous biliary biopsy procedure kit

Comprehensive Guide to CDSCO Licensing for Percutaneous Biliary Biopsy Procedure Kit

Navigating the regulatory landscape for medical devices in India can be complex, especially for specialized devices like the Percutaneous biliary biopsy procedure kit. This kit, classified as a Class B device under the CDSCO framework, plays a critical role in gastroenterology by enabling clinicians to obtain tissue specimens from the biliary duct system through a percutaneous endoscopic approach. Ensuring compliance with CDSCO regulations not only guarantees patient safety but also secures your product’s market access in India.

CDSCO Regulatory Framework for Percutaneous Biliary Biopsy Procedure Kit

The Central Drugs Standard Control Organization (CDSCO) governs the approval and licensing of medical devices in India. Since the Percutaneous biliary biopsy procedure kit is notified under the Notification 29/Misc./03/2020-DC (182), dated 27.09.2021, it falls under the ambit of the Medical Device Rules 2017.

As a Class B device, the licensing responsibility lies with the State Licensing Authority, and manufacturers must obtain the MD5 manufacturing license for domestic production. Importers, on the other hand, require the MD15 import license granted by the Central Licensing Authority.

Risk Classification and License Requirements

Class B devices are considered low to moderate risk. The Percutaneous biliary biopsy procedure kit involves sterile instruments used invasively, yet the risk profile aligns with Class B criteria based on the device’s intended use and patient impact.

• License Type: MD5 Manufacturing License (Form MD3 for application)
• Issuing Authority: State Licensing Authority
• Typical License Processing Time: 3 to 4 months
• Associated Test License: Required (Form MD13)

For a deeper dive into device classification, manufacturers can refer to the Medical Device Classification guide.

Manufacturing License Process (MD5) for Class B Devices

1. Obtain a Test License (Form MD13): This preliminary license is mandatory before manufacturing and testing. It takes approximately 1.5 to 2 months to process.
2. Product Testing: Conduct mandatory product testing in CDSCO-approved labs. Results must confirm safety and compliance.
3. Documentation Preparation: Compile all required documents, including Device Master File, Plant Master File, and Risk Management File.
4. Application Submission: Submit your MD5 license application (Form MD3) through the CDSCO MD Online Portal.
5. Audit by Notified Body: Coordinate with a notified body from the official list of notified bodies for audit and inspection.
6. Query Resolution: Address any queries raised by the regulatory authority or notified body promptly.
7. License Grant: Upon satisfactory review and audit, the MD5 license (Form MD5) is granted.

Manufacturing License Documents Required

For a Percutaneous biliary biopsy procedure kit, the document package should include:

• Company Constitution and Incorporation Certificate
• Proof of ownership/lease of manufacturing premises
• Details and qualifications of technical staff
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF) detailing design and specifications (Device Master File guide)
• Plant Master File detailing manufacturing processes (Plant Master File guide)
• Essential Principles Checklist demonstrating compliance with Indian standards
• Risk Management File tailored to the device (Risk Management resource)
• Test Reports from CDSCO-approved labs (Testing Laboratories list)
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents, preferably ISO 13485:2016 certification

Ensuring the completeness of these documents can significantly reduce processing delays.

Import License Process (MD15)

For importers aiming to bring the Percutaneous biliary biopsy procedure kit into India, the MD15 import license is mandatory. The process includes:

• Document preparation including Manufacturing License from the country of origin, Free Sale Certificate, CE Certificate, ISO 13485:2016, Device and Plant Master Files
• Application submission using Form MD14 on the CDSCO MD Online Portal
• Review and query resolution
• License issuance typically within 5 to 6 months

Refer to our detailed Import License Guide for stepwise assistance.

Import License Documents Required

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

Timeline and Processing Duration

The entire MD5 license process for this Class B device generally spans 3 to 4 months, broken down as:

• Test License (MD13) issuance: 1.5 to 2 months
• Product testing: 2 to 4 weeks
• Document preparation and submission: 2 to 3 weeks
• Audit and inspection by notified body: 2 to 3 weeks
• Query resolution and final approval: 2 to 4 weeks

Import licenses (MD15) typically take longer, around 5 to 6 months, primarily due to document verification and regulatory scrutiny.

Government Fees and Costs

• MD5 License Application Fee: Rs. 5,000 per application
• Product Fee: Rs. 500 per product

These fees are payable online via the CDSCO portal. Additional costs include testing fees charged by government-approved laboratories and notified body audit charges.

Common Challenges and Solutions

• Incomplete Documentation: Many manufacturers delay license approval by submitting incomplete Device or Plant Master Files. Investing time in comprehensive documentation upfront helps smooth the process.
• Delayed Testing: Testing duration can be unpredictable. Pre-book samples with CDSCO-approved labs early to avoid bottlenecks.
• Audit Non-Compliance: Non-conformities during notified body audits are a frequent cause of delays. Conduct internal audits and pre-assessment to ensure readiness.
• Slow Query Responses: Prompt and detailed responses to regulatory queries accelerate approvals.

Expert Consultation and Support

With over 25 years of experience assisting 500+ companies in securing CDSCO licenses, we specialize in guiding manufacturers and importers through every step of the regulatory journey. From document preparation to audit readiness and query management, our expertise simplifies compliance and expedites market entry.

Getting Started with Your CDSCO License Application

1. Assess your device classification: Confirm the Class B categorization of your Percutaneous biliary biopsy procedure kit using the CDSCO classification rules.
2. Prepare your Device and Plant Master Files: Utilize our resources to develop robust files compliant with CDSCO standards.
3. Apply for the Test License (Form MD13): Submit your initial application via the CDSCO MD Online Portal.
4. Schedule product testing: Coordinate with a CDSCO-approved testing laboratory to conduct mandatory product evaluations.
5. Compile full documentation: Assemble all required files and certifications carefully.
6. Submit MD5 License Application (Form MD3): After successful testing, apply for the manufacturing license.
7. Prepare for audit: Engage a notified body from the official list and get your facility and documents audit-ready.
8. Respond promptly to queries: Maintain open communication with regulatory authorities for swift resolution.

For tailored support and to streamline your licensing process, contact our regulatory consulting team today and leverage our proven track record in successful CDSCO approvals for gastroenterology devices like the Percutaneous biliary biopsy procedure kit.