CDSCO License for Cystometer
Medical Device Information
Intended Use
A device used to examine the bladder, providing measurement data concerning pressure and volume. This data will be used for diagnostic evaluation of the neuromuscular mechanisms of the bladder.
Comprehensive Guide to CDSCO Licensing for Cystometer (Class B Medical Device)
As specialists with over 25 years of experience in medical device regulatory compliance, we have successfully assisted more than 500 companies in obtaining CDSCO licenses across India. This guide provides an in-depth, step-by-step walkthrough on securing the necessary CDSCO license for a Cystometer—a Class B medical device used in urology for bladder diagnostics.
Understanding the Cystometer and Its Regulatory Importance
A Cystometer is a specialized device designed to measure bladder pressure and volume, aiding clinicians in diagnosing neuromuscular bladder disorders. Given its diagnostic nature and moderate risk profile, the Indian regulatory framework classifies it as a Class B device. Compliance with CDSCO regulations ensures the device meets safety, efficacy, and quality standards before entering the Indian market.
CDSCO Regulatory Framework for Cystometers (Class B Medical Device)
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules (MDR) 2017. As per the Medical Device Classification, Cystometers fall under Class B, necessitating a manufacturing license known as MD5, issued by the State Licensing Authority.
Risk Classification and License Requirements for Cystometers
- Risk Class: B (low-moderate risk)
- License Type: MD5 Manufacturing License
- Application Form: MD3
- Issuing Authority: State Licensing Authority
- Typical Timeline: 3-4 months (including test license and audit)
- Fees: Rs 5,000 (application) + Rs 500 per product
Manufacturing License Process (MD5) for Cystometer
Test License (Form MD13): Begin by applying for a test license, valid for 12 months, which allows you to manufacture the device for testing purposes. This step takes approximately 1.5 to 2 months.
Product Testing: Get the Cystometer tested at one of the government-approved testing laboratories. Tests include electrical safety, performance parameters, and biocompatibility as applicable.
Document Preparation: Compile all required documents including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and others.
Application Submission: Submit the manufacturing license application on the CDSCO MD Online Portal using Form MD3.
Audit by Notified Body: An audit by a notified body listed on the Notified Bodies List is mandatory. The audit assesses your manufacturing facility’s compliance to quality and regulatory standards.
Query Resolution: Respond promptly to any queries raised by the department or audit team.
License Grant: Upon satisfactory review, the MD5 license will be granted on Form MD5.
For detailed guidance, our MD5 License Guide provides an extensive overview.
Manufacturing License Documents Required for Cystometer
- Company Constitution or Incorporation Certificate
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Technical Staff Qualification and Experience Documents
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF) detailing design, materials, and specifications (Device Master File Guide)
- Plant Master File outlining manufacturing processes (Plant Master File Guide)
- Essential Principles Compliance Checklist
- Risk Management File demonstrating hazard analysis and mitigation (Risk Management)
- Test Reports from accredited laboratories
- Product Labels and Instructions for Use (IFU)
- Quality Management System Documents (ISO 13485 certification recommended)
Import License Process (MD15) for Cystometer
For importers intending to bring Cystometers into India, an MD15 import license from the Central Licensing Authority is mandatory. This process usually takes 5-6 months.
- Application Form: MD14
- Documents Required: Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files, Wholesale License, Company Constitution
- Fees: Rs 2000 per site + Rs 1000 per product for Class B
Submit your application through the CDSCO MD Online Portal. For more details, see our Import License Guide.
Timeline and Processing Duration
| Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 2 – 4 weeks |
| Document Preparation | 2 – 3 weeks |
| Application Processing | 1 – 2 months |
| Audit & Query Resolution | 3 – 4 weeks |
| Total Time | 3 – 4 months |
Government Fees and Costs
- Test License (MD13): Rs 2,000 approximately
- MD5 License Application: Rs 5,000 per application
- Product Fee: Rs 500 per device
- Audit Fees: Usually borne by the manufacturer and varies by notified body
Budgeting realistically for these expenses upfront will ensure smooth licensing without unexpected delays.
Common Challenges and Practical Solutions
Delayed Testing Reports: Plan testing well in advance and select accredited labs early. Utilize the Testing Laboratories list to identify nearby facilities.
Incomplete Documentation: Use our comprehensive checklists and templates for Device Master File and Plant Master File to avoid omissions.
Notified Body Audit Non-Compliance: Engage consultants for pre-audit readiness checks and corrective action plans.
Regulatory Updates: Stay updated on notifications such as File No. 29/Misc./03/2020-DC (145) dated 23.8.2021 affecting device classification and requirements.
Expert Consultation and Support
With our extensive experience, we provide end-to-end consultancy—from documentation, application filing, to audit preparation. Our clients benefit from:
- Tailored regulatory strategies
- Hands-on guidance on document preparation
- Liaison with CDSCO and notified bodies
- Post-license compliance and renewal support
Getting Started with Your CDSCO License Application for Cystometer
- Assess Your Device Classification: Confirm your device class as B using the Medical Device Classification tool.
- Prepare Documentation: Begin assembling your Device Master File, Plant Master File, Risk Management File, and related documents.
- Apply for Test License (Form MD13): Submit through the CDSCO MD Online Portal.
- Schedule Product Testing: Contact notified testing labs promptly.
- Plan for Audit: Identify a notified body for your manufacturing site audit.
- Submit MD5 Application (Form MD3): Upon test license approval and successful testing.
- Address Queries Diligently: Respond quickly to ensure timely license grant.
Embarking on this process with a clear roadmap and expert guidance will significantly improve your chances of a smooth and timely approval. Contact us to leverage our proven expertise and make your Cystometer’s entry into the Indian market seamless and compliant.
