CDSCO License for Bladder-supporting pessary
Medical Device Information
Intended Use
inserted into the vagina to facilitate management of female urinary incontinence and/or to reduce bladder prolapse.
Comprehensive Guide to CDSCO Licensing for Bladder-Supporting Pessaries (Class B Medical Device)
Bladder-supporting pessaries play a vital role in women's health by managing urinary incontinence and reducing bladder prolapse. Classified as Class B under the Indian Medical Device Rules, these obstetrical and gynecological devices require meticulous regulatory compliance with the Central Drugs Standard Control Organization (CDSCO). With over 25 years of experience and having assisted 500+ companies navigate India’s regulatory landscape, we present a detailed, step-by-step guide to help manufacturers and importers successfully obtain the required CDSCO license.
Understanding the CDSCO Regulatory Framework for Bladder-Supporting Pessaries
As per the notification File No. 29/Misc./03/2020-DC (181) dated 03.06.2022, bladder-supporting pessaries fall under Class B medical devices. This classification mandates obtaining a manufacturing license via Form MD3 (MD5 license) from the State Licensing Authority. The regulatory objective is to ensure safety, efficacy, and quality compliance before these devices reach Indian patients.
Manufacturers must also comply with the Medical Device Rules (MDR) 2017, and all applications must be submitted through the CDSCO MD Online Portal for seamless processing.
Risk Classification and License Requirements for Class B Devices
Class B devices are considered low to moderate risk, requiring a thorough but streamlined approval process compared to higher-risk Classes C and D. For bladder-supporting pessaries:
- License Type: MD5 Manufacturing License (Form MD3)
- Licensing Authority: State Licensing Authority
- Process Duration: Approximately 3-4 months
- Fee Structure: Rs 5000 per application + Rs 500 per product
This pathway is designed to balance patient safety with industry facilitation.
Step-by-Step Manufacturing License Process (MD5) for Bladder-Supporting Pessaries
Test License (Form MD13):
- Apply for a test license first, which takes about 1.5 to 2 months.
- This permits product testing at government-approved labs.
- Refer to the list of CDSCO-approved testing laboratories to select the right facility.
Product Testing:
- Conduct mandatory tests for safety and performance as per relevant standards.
- Test reports form a crucial part of the licensing dossier.
Document Preparation:
- Assemble all required documentation, including quality management systems and technical files.
Application Submission:
- Submit the manufacturing license application via Form MD3 on the MD Online Portal.
Audit by Notified Body:
- An audit is conducted by a notified body to verify manufacturing compliance.
- Review the list of notified bodies authorized for Class B device audits.
Query Resolution:
- Respond promptly and comprehensively to any queries from CDSCO or the notified body.
License Grant:
- Upon satisfactory compliance, the MD5 license is issued.
Essential Documents Required for MD5 License Application
To ensure smooth approval, prepare the following documents meticulously:
- Company Constitution and Incorporation Certificate
- Proof of Ownership or 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, materials, and performance specifications (See our Device Master File guide)
- Plant Master File (PMF) describing manufacturing premises and processes (Learn more about PMF)
- Essential Principles Checklist confirming compliance with regulatory standards
- Risk Management File demonstrating hazard analysis and mitigation (Risk Management insights)
- Test Reports from approved laboratories
- Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents, preferably ISO 13485 compliant
Import License Process (MD15) for Bladder-Supporting Pessaries
If your company plans to import bladder-supporting pessaries, the process differs:
- License Type: MD15 Import License (Form MD14)
- Authority: Central Licensing Authority (CDSCO HQ)
- Timeline: 5-6 months
- Fees: Vary by class; for Class B, typically Rs 2000 per site + Rs 1000 per product
- Document Requirements:
- Valid Manufacturing License from country of origin
- Free Sale Certificate
- ISO 13485:2016 Certificate
- CE Certificate or equivalent
- Device Master File
- Plant Master File
- Wholesale License
- Company Constitution
The import license requires robust documentation and close coordination with CDSCO officials.
Timeline and Processing Duration
| Stage | Duration |
|---|---|
| Test License Application | 1.5 - 2 months |
| Product Testing | 3 - 4 weeks (varies by lab) |
| Document Preparation | 2 - 4 weeks |
| Application & Audit | 1 - 1.5 months |
| Query Resolution & Granting | 2 - 4 weeks |
Total: Approximately 3 to 4 months for MD5 license.
Government Fees and Cost Breakdown
- MD5 License: Rs 5000 per application + Rs 500 per product
- Test License (MD13): Typically included in the overall process
- Additional Costs:
- Testing laboratory fees (varies by test scope)
- Notified body audit charges
- Documentation preparation and consultancy (optional but recommended)
Common Challenges and Practical Solutions
Challenge: Delays in test report issuance
Solution: Choose CDSCO-approved labs with proven turnaround times; pre-book testing slots early.
Challenge: Incomplete or inconsistent documentation
Solution: Utilize comprehensive templates and checklists; consider expert consultancy to avoid common pitfalls.
Challenge: Audit non-compliance findings
Solution: Conduct internal pre-audits; ensure robust QMS and traceability prior to notified body visits.
Challenge: Slow query resolution
Solution: Assign a dedicated regulatory liaison to address queries promptly and accurately.
Expert Consultation and Support
Navigating CDSCO licensing demands detailed knowledge and experience. Our team has successfully guided over 500 manufacturers and importers in securing timely approvals for devices like bladder-supporting pessaries. Leveraging our expertise can significantly reduce regulatory risks, minimize delays, and optimize resource allocation.
Whether you require assistance with document preparation, audit readiness, or application submission via the CDSCO MD Online Portal, we offer tailored solutions to meet your needs.
Getting Started with Your CDSCO License Application for Bladder-Supporting Pessaries
Assess Device Classification: Confirm your device fits Class B criteria through official guidelines (Medical Device Classification).
Prepare Required Documents: Begin compiling the Device Master File, Plant Master File, and QMS documentation.
Select Testing Laboratory and Notified Body: Early identification expedites scheduling.
Apply for Test License (MD13): Submit your application on the CDSCO portal.
Coordinate Testing and Audit: Plan timelines carefully to align with your product launch schedule.
Consult Experts: Engage with seasoned regulatory consultants to streamline the process.
Launching your bladder-supporting pessary in India is a promising opportunity with the right regulatory strategy. Start today by leveraging our proven roadmap to CDSCO licensing success.
For detailed assistance, contact our regulatory experts or visit the MD5 License Guide to deepen your understanding.
