CDSCO License for Uterine probe, reusable

Comprehensive Guide to CDSCO Licensing for Reusable Uterine Probes (Class B Medical Device)

Introduction: Understanding Your Device and Regulatory Importance

The reusable uterine probe is a specialized obstetrical and gynecological medical device intended for exploring the uterus during surgical procedures, often functioning as a component of a uterine manipulator. Given its direct application in invasive procedures, regulatory compliance is critical to ensure patient safety and market access in India. The Central Drugs Standard Control Organization (CDSCO) governs the licensing and quality standards for such medical devices.

Our firm, with over 25 years of experience and having assisted 500+ companies, provides you with an expert roadmap tailored specifically for obtaining the CDSCO license for your reusable uterine probe, classified under risk Class B.

CDSCO Regulatory Framework for Reusable Uterine Probes

The CDSCO classifies medical devices based on risk, intended use, and invasiveness. Your uterine probe falls under Class B — low to moderate risk — requiring adherence to specific regulatory pathways designed to ensure safety without unnecessary delays.

The regulatory framework mandates:

• Obtaining a Manufacturing License (MD5) for Class A and B devices granted by the State Licensing Authority.
• Compliance with testing, quality management system standards, and audit requirements.

Your device is notified under File No. 29/Misc./03/2020-DC (181) dated 03.6.2022, confirming its regulatory classification and compliance requirements.

Risk Classification and License Requirements

• Device: Reusable Uterine Probe
• Risk Class: B (Low-Moderate Risk)
• License Type: MD5 Manufacturing License
• Regulatory Authority: State Licensing Authority

Class B devices require the MD5 license, which involves product testing, audit by a notified body, and submission of detailed documentation.

For full details on medical device classification, you can reference our Medical Device Classification guide.

Manufacturing License Process (MD5)

Obtaining the MD5 license involves several sequential steps:

1. Apply for Test License (Form MD13): Before manufacturing, obtain a test license on Form MD13. This allows you to produce test samples for laboratory testing.
2. Testing: Get your uterine probe tested in government-approved laboratories to verify compliance with applicable standards.
3. Document Preparation: Develop and compile technical documentation including Device Master File, Plant Master File, Risk Management File, QMS documents, and labeling.
4. Application Submission (Form MD3): Submit the MD5 license application through the CDSCO MD Online Portal.
5. Audit by Notified Body: The State Licensing Authority arranges an audit by a notified body from the official list of notified bodies.
6. Query Resolution: Address any queries raised by the regulatory department or notified body promptly.
7. Grant of MD5 License: Upon satisfactory review and audit, the license is granted on Form MD5.

For detailed steps and document templates, visit our MD5 License Guide.

Manufacturing License Documents Required

Prepare the following documents meticulously to ensure smooth processing:

• Company Constitution: Proof of legal entity, registration certificates.
• Proof of Premises Ownership or Lease: Valid documents confirming manufacturing site.
• Technical Staff Details: Qualification and experience certificates of responsible technical personnel.
• Fire NOC & Pollution Control NOC: Compliance certificates from local authorities.
• Device Master File (DMF): Comprehensive technical details, design, and manufacturing processes. Our Device Master File guide can assist.
• Plant Master File: Details of manufacturing facility, equipment, and quality controls. Refer to our Plant Master File guide.
• Essential Principles Checklist: Declaration of conformity with Indian regulatory requirements.
• Risk Management File: Documented risk analysis and mitigation strategies. Learn more in our Risk Management guide.
• Test Reports: From government-approved labs listed here.
• Labels and Instructions for Use (IFU): Product labeling and user manuals.
• Quality Management System (QMS) Documents: ISO 13485 certification and internal quality procedures.

Import License Process (MD15)

If you plan to import the reusable uterine probe instead of manufacturing domestically, the MD15 Import License is required. This license is granted by the Central Licensing Authority and involves:

• Preparing comprehensive documentation such as Manufacturing License of the foreign manufacturer, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device Master File, Plant Master File, Wholesale License, and Company Constitution.
• Submitting the application on Form MD14 through the CDSCO MD Online Portal.
• Responding to queries from CDSCO until approval.

The process typically takes 5-6 months.

For a detailed walkthrough, see our Import License Guide.

Import License Documents Required

• Valid manufacturing license from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale License for distribution in India
• Company Constitution Documents

Timeline and Processing Duration

From start to finish, the entire MD5 license process for a Class B reusable uterine probe generally takes around 3 to 4 months, assuming timely testing and prompt responses to queries.

Government Fees and Costs

• Test License (MD13): Fee included in application
• MD5 License Application: ₹5,000 per application
• Per Product Fee: ₹500 for each product variant

Additional costs may include notified body audit fees (varies by agency), lab testing charges, and consultancy fees if applicable.

Common Challenges and Solutions

Challenge: Delay in product testing due to limited slots at government labs.

Solution: Schedule testing early and consider multiple approved labs listed on the CDSCO Testing Laboratories list.

Challenge: Incomplete documentation causing back-and-forth queries.

Solution: Utilize our comprehensive checklist and templates for Device Master File, Plant Master File, and Risk Management File.

Challenge: Audit scheduling delays with notified bodies.

Solution: Engage notified bodies early from the official Notified Bodies List and maintain clear communication.

Expert Consultation and Support

Navigating CDSCO regulations can be complex, especially for devices like reusable uterine probes that require stringent quality and safety checks. Our extensive experience with over 500 successful client licenses means we can:

• Assist with document preparation and review
• Coordinate testing and notified body audits
• Provide timely responses to regulatory queries
• Offer training for your technical and quality teams

Partnering with experts ensures faster approvals, cost savings, and compliance confidence.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your uterine probe’s Class B status.
2. Register on the CDSCO MD Online Portal: Create your account at the CDSCO MD Online Portal.
3. Prepare Required Documentation: Use our guides to compile Device and Plant Master Files, Risk Management Files, and QMS documents.
4. Apply for Test License (MD13): Initiate manufacturing for testing purposes.
5. Schedule Product Testing: Book testing slots at approved laboratories early.
6. Apply for MD5 License (Form MD3): Following successful testing, submit your manufacturing license application.
7. Coordinate Audit and Respond to Queries: Work closely with the notified body and CDSCO to address any observations.
8. Receive License and Commence Manufacturing: Once granted, ensure ongoing compliance and quality surveillance.

Starting early and maintaining meticulous documentation are key to a smooth licensing journey. For personalized assistance, contact us to leverage our 25+ years of regulatory expertise in India’s medical device sector.