CDSCO License for Flexible fibreoptic choledochoscope

Comprehensive Guide to CDSCO Licensing for Flexible Fibreoptic Choledochoscope (Class B Medical Device)

The flexible fibreoptic choledochoscope is a specialized gastroenterology medical device designed for the visual examination and treatment of the common bile duct (CBD). Given its critical application, it falls under the Class B risk classification according to CDSCO regulations. Ensuring compliance with India's regulatory framework is paramount for manufacturers and importers aiming to market this device in India.

With over 25 years of experience and having supported 500+ companies in navigating CDSCO licensing, we provide you with a detailed, step-by-step guide to obtaining the necessary approvals for your flexible fibreoptic choledochoscope.

CDSCO Regulatory Framework for Flexible Fibreoptic Choledochoscope

The Central Drugs Standard Control Organization (CDSCO) oversees medical device regulations in India. As per Notification 29/Misc./03/2020-DC (182) dated 27.09.2021, the flexible fibreoptic choledochoscope is categorized under gastroenterology devices and classified as a Class B device.

Class B devices are considered low to moderate risk, requiring a state-level manufacturing license (MD5) and adherence to specific documentation and testing protocols. The CDSCO mandates strict compliance with safety, efficacy, and quality standards to protect patient health.

Risk Classification and License Requirements

• Device: Flexible fibreoptic choledochoscope
• Risk Class: B (Low to Moderate Risk)
• Regulatory Pathway: MD5 Manufacturing License (via State Licensing Authority)
• Application Forms: Test License - MD13, Manufacturing License - MD3

Class B devices require a phased approach:

1. Obtain a Test License (Form MD13)
2. Conduct product testing at CDSCO-approved laboratories
3. Prepare and submit the manufacturing license application (Form MD3)
4. Undergo an audit by a notified body
5. Address any queries raised by authorities
6. Receive the MD5 license

For detailed classification, refer to the Medical Device Classification guide.

Manufacturing License Process for MD5 (Class B Devices)

The MD5 license is issued by the State Licensing Authority. The entire process typically takes 3 to 4 months. Here’s an outline:

Step 1: Apply for Test License (Form MD13)

• Duration: 1.5 to 2 months
• Purpose: To legally manufacture samples for testing

Step 2: Product Testing

• Conduct testing at government-approved laboratories listed here.
• Tests include biocompatibility, electrical safety, and performance as per applicable standards.

Step 3: Prepare Documentation

• Compile all necessary documents including Device Master File (DMF), Plant Master File (PMF), Quality Management System (QMS) records, and risk management reports.

Step 4: Submit Manufacturing License Application (Form MD3)

• Submit via the CDSCO MD Online Portal.

Step 5: Audit by Notified Body

• An audit is conducted to verify compliance.
• Find notified bodies for MD5 audits here.

Step 6: Query Resolution

• Address any queries raised by CDSCO or the notified body promptly.

Step 7: License Grant (Form MD5)

• Upon satisfactory review, the MD5 license is issued.

Manufacturing License Documents Required for Flexible Fibreoptic Choledochoscope

Ensure the following are prepared and uploaded with your application:

• Company Constitution Documents: Incorporation certificate, partnership deed, etc.
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualification and Experience Certificates
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF): Detailed design and manufacturing information. Learn more in our Device Master File guide.
• Plant Master File (PMF): Details of manufacturing facilities. Refer to our Plant Master File guide.
• Essential Principles Checklist: Demonstrating compliance with safety and performance standards
• Risk Management File: As per ISO 14971. See our Risk Management insights.
• Test Reports: From CDSCO-recognized labs
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents: ISO 13485 certification is highly recommended

Import License Process (MD15) for Flexible Fibreoptic Choledochoscope

If you are an importer, the MD15 license is mandatory, granted by the Central Licensing Authority. The process timeline is about 5 to 6 months.

Key Steps:

1. Prepare required documents, including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, DMF, PMF, and wholesale license.
2. Submit application on the CDSCO MD Online Portal.
3. Respond to any departmental queries.
4. License is granted on Form MD15.

For detailed import license guidance, visit our Import License Guide.

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 and Plant Master File
• Wholesale License
• Company Constitution Documents
• Application Form MD14

Timeline and Processing Duration

Note: Timelines can vary based on audit scheduling and query resolution efficiency.

Government Fees and Costs

Additional costs to consider:

• Laboratory testing fees (varies by test and lab)
• Notified body audit charges
• Consultancy fees if you engage expert assistance

Common Challenges and Solutions

• Challenge: Delays in product testing due to lab backlogs.

  • Solution: Schedule testing early and choose labs with shorter turnaround times from the approved testing laboratories list.

• Challenge: Incomplete or inconsistent documentation.

  • Solution: Use our comprehensive checklists and templates to prepare DMF, PMF, and risk files.

• Challenge: Audit non-conformities leading to repeated inspections.

  • Solution: Conduct internal audits and pre-assessment reviews before notified body audits.

• Challenge: Query resolution delays.

  • Solution: Assign dedicated regulatory personnel to respond promptly with clear, evidence-backed replies.

Expert Consultation and Support

Navigating the CDSCO regulatory landscape can be complex, especially for devices like the flexible fibreoptic choledochoscope. Leveraging our 25+ years of expertise, we have helped over 500 companies streamline their licensing process, avoid pitfalls, and achieve faster approvals.

We offer:

• End-to-end application preparation
• Documentation drafting and review
• Coordination with notified bodies and testing labs
• Regulatory strategy tailored to your device class

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your device is Class B using CDSCO guidelines.
2. Initiate Test License Application: Prepare technical documentation and submit Form MD13 via the CDSCO MD Online Portal.
3. Engage Accredited Testing Labs: Plan and schedule product testing early.
4. Prepare Complete Documentation: Compile DMF, PMF, risk management, and QMS files.
5. Submit Manufacturing License Application (MD3): Post testing, upload all documents online.
6. Plan for Audit: Coordinate with notified bodies to schedule audits.
7. Respond to Queries Promptly: Ensure swift communication with CDSCO for any clarifications.

Starting early and following this roadmap will significantly improve your chances of timely license approval.

For detailed guidance on MD5 license acquisition, visit our MD5 License Guide.

By adhering to these best practices and timelines, manufacturers and importers of flexible fibreoptic choledochoscope devices can confidently navigate the CDSCO licensing process, ensuring compliance and market access in India.