CDSCO License for Pelvic examination kit

Comprehensive CDSCO Licensing Guide for Pelvic Examination Kits (Class B Medical Device)

Pelvic examination kits are essential tools in obstetrical and gynecological healthcare, enabling clinicians to perform accurate pelvic assessments safely and effectively. Given their critical role in women's health, these kits fall under Class B medical devices according to CDSCO regulations. Ensuring timely and compliant market entry in India requires navigating the CDSCO licensing framework meticulously.

With over 25 years of experience assisting 500+ companies across medical device regulatory pathways, we provide you with expert insights to streamline your Pelvic Examination Kit's CDSCO licensing process.

CDSCO Regulatory Framework for Pelvic Examination Kits

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules, 2017 (MDR 2017). Pelvic examination kits are notified under File No. 29/Misc./03/2020-DC (181) dated 03.6.2022 and classified as Class B devices, which mandates obtaining a manufacturing license from the State Licensing Authority via MD5 license application.

Risk Classification and License Requirements for Pelvic Examination Kits

As per the CDSCO classification:

• Device Name: Pelvic Examination Kit
• Risk Class: B (Low to moderate risk)
• Category: Obstetrical and Gynecological
• Notification Date: 03 June 2022

Class B devices require an MD5 license (Form MD3 application) from the State Licensing Authority for manufacturing within India. This license ensures compliance with safety, quality, and efficacy standards.

Manufacturing License Process (MD5) for Pelvic Examination Kits

The MD5 manufacturing license process is a stepwise approach involving:

1. Test License (Form MD13): Obtain a test license valid for 2 years, allowing initial manufacturing and testing.
2. Product Testing: Submit the kit for mandatory testing at government-approved laboratories listed on the CDSCO Testing Laboratories page.
3. Documentation Preparation: Prepare comprehensive technical documentation including Device Master File and Plant Master File.
4. Application Submission (Form MD3): File the manufacturing license application via the CDSCO MD Online Portal.
5. Audit by Notified Body: Undergo audit by a notified body certified for Class B devices, listed here.
6. Resolution of Queries: Address any observations or queries raised by CDSCO or the notified body.
7. Grant of MD5 License: Upon satisfactory compliance, the license is granted on Form MD5.

Manufacturing License Documents Required for Pelvic Examination Kits

For a smooth application, ensure preparation of the following documents:

• Company Constitution Documents: Memorandum & Articles of Association, incorporation certificates.
• Proof of Premises Ownership: Rent agreement or ownership proof.
• Technical Staff Details: Qualification and experience certificates of technical personnel.
• Fire NOC and Pollution Control NOC: From relevant authorities.
• Device Master File (DMF): Detailed product specifications, design, manufacturing process, and quality controls. Our Device Master File Guide offers valuable insights.
• Plant Master File (PMF): Facility layout, equipment details, and quality system overview as outlined in our Plant Master File Guide.
• Essential Principles Checklist: Compliance checklist with MDR 2017 essential principles.
• Risk Management File: Documentation showing risk analysis and mitigation per ISO 14971 standards. Refer to our Risk Management Guide.
• Test Reports: From CDSCO approved labs validating safety and performance.
• Product Labels and Instructions for Use (IFU): Compliant with labeling regulations.
• Quality Management System (QMS) Documents: ISO 13485:2016 certification and procedures.

Import License Process (MD15) for Pelvic Examination Kits

If you plan to import pelvic examination kits, an MD15 import license from the Central Licensing Authority is mandatory. This process includes:

• Document preparation including manufacturing license, Free Sale Certificate, CE Certificate, ISO 13485:2016, DMF, PMF, and wholesale license.
• Application submission via the CDSCO MD Online Portal.
• Resolution of queries raised by CDSCO.
• Grant of MD15 import license.

The entire process usually takes 5-6 months.

Import License Documents Required

• 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 documents

Timeline and Processing Duration for Pelvic Examination Kit Licensing

Government Fees and Costs

• Test License (MD13) Fees: Included in application
• MD5 Manufacturing License Fees:
  • Application Fee: Rs. 5,000
  • Per Product Fee: Rs. 500

For example, if you apply for 3 pelvic examination kit variants, total fees = Rs. 5,000 + (3 x Rs. 500) = Rs. 6,500.

Common Challenges and Solutions

Challenge 1: Delays in Product Testing

• Solution: Engage early with notified testing labs to schedule tests and obtain clear test protocols.

Challenge 2: Incomplete Documentation

• Solution: Use detailed checklists and templates for DMF, PMF, and Risk Management files. Our guides can help ensure completeness.

Challenge 3: Audit Observations

• Solution: Pre-audit internal checks and mock audits help in identifying gaps before the notified body visits.

Challenge 4: Query Resolution Delays

• Solution: Prepare prompt, detailed responses with supporting evidence to avoid back-and-forth delays.

Expert Consultation and Support

Navigating CDSCO licensing for pelvic examination kits can be complex. With our 25+ years of expertise and proven track record with 500+ clients, we offer:

• Tailored regulatory strategy and roadmap
• Documentation development and review
• Coordination with testing labs and notified bodies
• Application submission and follow-up
• Training on compliance and post-license obligations

Our comprehensive MD5 License Guide provides further insights on the process.

Getting Started with Your CDSCO License Application

1. Determine your device classification: Confirm Pelvic Examination Kit as Class B.
2. Assess your manufacturing capabilities: Ensure your facility meets GMP and QMS requirements.
3. Initiate Test License application: File Form MD13 on the CDSCO MD Online Portal.
4. Schedule product testing: Engage approved labs early.
5. Compile required documents: Use our linked guides for DMF, PMF, and risk management.
6. Submit manufacturing license application (Form MD3): Post-test license and product testing.
7. Prepare for audit: Coordinate with notified bodies and conduct internal readiness assessments.
8. Respond to queries promptly: Maintain clear communication with CDSCO.

Taking these practical steps will position your pelvic examination kit for a successful and timely CDSCO manufacturing license approval, helping you serve the Indian healthcare market efficiently.

For personalized assistance or to kickstart your application, contact our regulatory experts who have guided hundreds of medical device firms through CDSCO licensing seamlessly.