CDSCO License for Intraurethral valve/pump

Comprehensive Guide to CDSCO Licensing for Intraurethral Valve/Pump (Class B Medical Device)

Entering the Indian medical device market requires navigating a well-defined regulatory pathway administered by the Central Drugs Standard Control Organization (CDSCO). For manufacturers and importers of the intraurethral valve/pump — a sterile, non-powered Class B urology device designed to aid female patients with incomplete bladder emptying due to impaired detrusor contractility of neurologic origin — understanding the CDSCO licensing framework is crucial.

With over 25 years of expertise and having supported more than 500 companies in securing CDSCO approvals, we provide you with a step-by-step breakdown specific to this device type.

CDSCO Regulatory Framework for Intraurethral Valve/Pump

The intraurethral valve/pump falls under the urology category and is classified as a Class B medical device according to the CDSCO risk classification. Class B devices are considered low to moderate risk and are regulated primarily at the state level via the issuance of an MD5 manufacturing license. This device is notified under File No. 29/Misc./03/2020-DC (145) dated 23.8.2021.

Regulatory compliance ensures patient safety, product efficacy, and market access. The CDSCO mandates conformity with the Medical Device Rules (MDR), 2017, including essential principles such as sterility, biocompatibility, and quality management system adherence.

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

Risk Classification and License Requirements

• Risk Class: B
• License Required: MD5 (Manufacturing License for Class A and B devices)
• Authority: State Licensing Authority

Class B devices require manufacturers to secure an MD5 license, which involves a multi-step process including test license acquisition, product testing, documentation, notified body audit, and final license grant.

Manufacturing License Process (MD5) for Intraurethral Valve/Pump

1. Apply for Test License (Form MD13):
   • Duration: Approximately 1.5 to 2 months
   • Allows manufacturing of the device for testing purposes
2. Product Testing:
   • Conduct mandatory tests on the device through CDSCO-approved testing laboratories
   • Refer to the list of Testing Laboratories for selection
3. Preparation of Documentation:
   • Compile Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and QMS documents
   • Ensure sterility validation and biocompatibility reports are included
   • Utilize our detailed Device Master File guide and Plant Master File guide for assistance
4. Submission of Application (Form MD3):
   • Submit the manufacturing license application via the CDSCO MD Online Portal
5. Audit by Notified Body:
   • Engage a notified body listed in the CDSCO Notified Bodies list for site audit
6. Resolution of Queries:
   • Address any observations or deficiencies raised by the CDSCO or notified body promptly
7. Grant of License (Form MD5):
   • Upon successful audit and document verification, the MD5 license is issued

Manufacturing License Documents Required for Intraurethral Valve/Pump

• Company Constitution (e.g., Memorandum and Articles of Association)
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Details (Qualifications and Experience)
• Fire NOC and Pollution Control NOC
• Device Master File (DMF)
• Plant Master File (PMF)
• Essential Principles Checklist
• Risk Management File tailored to device risks (refer to Risk Management guide)
• Product Test Reports from CDSCO-approved labs
• Labels and Instructions for Use (IFU) compliant with MDR
• Quality Management System (QMS) Documents (e.g., ISO 13485 certification)

Preparation of these documents requires meticulous attention to detail to avoid delays.

Import License Process (MD15) for Intraurethral Valve/Pump

While the intraurethral valve/pump is primarily manufactured domestically, importers must apply for an MD15 license granted by the Central Licensing Authority:

1. Document Preparation:
   • Manufacturing license from country of origin
   • Free Sale Certificate
   • ISO 13485:2016 and CE Certificate
   • Device Master File & Plant Master File
   • Wholesale License
   • Company Constitution
2. Application Submission:
   • Submit Form MD14 via the CDSCO MD Online Portal
3. Queries Resolution:
   • Respond to any clarifications requested by CDSCO
4. License Grant:
   • Typically takes 5-6 months

Import License Documents Required

• Valid Manufacturing License from exporting country
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate
• Device Master File and Plant Master File
• Wholesale License
• Company Constitution

Timeline and Processing Duration

Total Estimated Time: Approximately 3 to 4 months for MD5 license

For import license (MD15), the process usually extends to 5-6 months.

Government Fees and Costs

• MD5 Manufacturing License:
  • Application fee: Rs. 5,000
  • Per product fee: Rs. 500
• Test License (MD13):
  • Included in MD5 application process

Additional costs include testing laboratory fees (variable), notified body audit charges, and document preparation consultancy if outsourced.

Common Challenges and Solutions

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

  • Solution: Schedule testing early and select laboratories with shorter turnaround times from the Testing Laboratories list.

• Challenge: Incomplete or inconsistent documentation causing audit observations.

  • Solution: Engage experienced consultants and conduct internal audits before submission.

• Challenge: Queries from CDSCO leading to prolonged approval.

  • Solution: Prepare comprehensive responses, supported by evidence, and maintain proactive communication with authorities.

• Challenge: Understanding Indian regulatory nuances for a specialized urology device.

  • Solution: Utilize expert guidance tailored for your device category.

Expert Consultation and Support

Navigating CDSCO licensing, especially for specialized devices like intraurethral valve/pump, can be complex. Our team has successfully assisted over 500 manufacturers and importers in obtaining timely approvals by:

• Assisting with test license applications
• Coordinating product testing with CDSCO-approved labs
• Preparing robust regulatory documentation
• Liaising with notified bodies and CDSCO officials
• Offering post-license compliance support

Partnering with seasoned consultants reduces errors, expedites approvals, and helps avoid costly rejections.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm your intraurethral valve/pump is Class B.
2. Register on CDSCO MD Online Portal: Create your account at the CDSCO MD Online Portal to initiate applications.
3. Apply for Test License (MD13): Begin the process to manufacture test batches.
4. Engage Testing Laboratories: Identify a CDSCO-approved lab early and schedule testing.
5. Prepare Documentation: Gather and draft all required files including DMF, PMF, risk management, and QMS.
6. Plan for Audit: Contact notified bodies from the Notified Bodies List to schedule audits.
7. Submit Application for MD5 License: Complete Form MD3 submission online.
8. Respond Promptly to Queries: Maintain prompt communication with CDSCO and notified bodies.

By following these actionable steps and leveraging experienced regulatory support, manufacturers and importers of intraurethral valve/pump devices can achieve CDSCO licensing efficiently and compliantly, facilitating smooth market entry in India.