CDSCO License for Endometrial cytology brush

Comprehensive Guide to CDSCO Licensing for Endometrial Cytology Brush (Class B Device)

As a trusted regulatory consultant with over 25 years of experience assisting more than 500 companies, we understand the complexities involved in obtaining CDSCO licenses for medical devices like the Endometrial Cytology Brush. This device, classified as Class B under the obstetrical and gynecological category, requires compliance with specific regulatory frameworks to enter the Indian market legally and efficiently.

Introduction: Endometrial Cytology Brush and Its Regulatory Importance

The Endometrial Cytology Brush is a specialized medical device used during endoscopic examinations to collect mucosal cells for pathological diagnosis. Given its application in sensitive gynecological procedures, rigorous regulatory oversight ensures safety and efficacy for patients. The device falls under Class B risk classification, indicating a moderate risk level that mandates a State Licensing Authority manufacturing license (MD5) under the Central Drugs Standard Control Organisation (CDSCO).

The CDSCO notification number 29/Misc./03/2020-DC (181), dated 03.06.2022, officially recognizes this device under the specified category, emphasizing the need for manufacturers and importers to comply with all regulatory requirements.

CDSCO Regulatory Framework for Endometrial Cytology Brush

The CDSCO governs medical devices based on risk classification, mandating different licensing pathways for manufacturers and importers. For the Endometrial Cytology Brush, classified as Class B, the applicable license is the MD5 Manufacturing License, granted by the State Licensing Authority. The regulatory process ensures that the device meets essential safety, quality, and performance standards before entering the Indian market.

Manufacturers must adhere to the Medical Device Rules, 2017, and comply with essential principles such as Good Manufacturing Practices (GMP), Quality Management Systems (QMS), and risk management protocols.

Risk Classification and License Requirements for Class B Devices

Class B devices like the Endometrial Cytology Brush are considered low to moderate risk and require the following:

• Manufacturing License: MD5 License (Application Form MD3) issued by the State Licensing Authority.
• Test License: Initially, a Test License on Form MD13 for product testing.
• Audit: Quality system audit by a notified body.

This tiered approach balances regulatory oversight with streamlined procedures suitable for moderate-risk devices.

Manufacturing License Process for Endometrial Cytology Brush (MD5)

The MD5 license process typically spans 3 to 4 months and involves multiple stages:

1. Test License Application (Form MD13): Submit application via the CDSCO MD Online Portal for a test license, which takes around 1.5 to 2 months to obtain.
2. Product Testing: Conduct mandatory testing at government-approved laboratories. You can refer to the list of testing laboratories authorized by CDSCO.
3. Document Preparation: Compile comprehensive documentation including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and QMS documents.
4. License Application (Form MD3): Apply for the MD5 manufacturing license through the online portal.
5. Audit by Notified Body: Arrange for an audit by a notified body listed here to verify compliance with quality standards.
6. Query Resolution: Address any queries raised by the licensing authority or notified body.
7. Grant of License: Upon satisfactory evaluation, the MD5 license is granted on Form MD5.

Manufacturing License Documents Required for Class B Device

To ensure a smooth application process, prepare the following critical documents:

• Company Constitution (Incorporation Certificate, MoA, AoA)
• Proof of Ownership or Tenancy Agreement of Manufacturing Premises
• Qualification and Experience Certificates of Technical Staff
• Fire Safety NOC
• Pollution Control Board NOC
• Device Master File (DMF) – detailing device design, materials, and specifications (Device Master File Guide)
• Plant Master File (PMF) – outlining manufacturing facilities and processes (Plant Master File Guide)
• Essential Principles Checklist
• Risk Management File (Risk Management Implementation)
• Test Reports from approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documentation (ISO 13485 compliance)

Organizing these documents meticulously will reduce back-and-forth during the evaluation.

Import License Process (MD15) for Endometrial Cytology Brush

If importing the Endometrial Cytology Brush, the MD15 license is mandatory, granted by the Central Licensing Authority. The process typically takes 5 to 6 months and involves:

• Preparing comprehensive documentation including Manufacturing License, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, Device Master File, Plant Master File, Wholesale License, and Company Constitution.
• Applying online on the CDSCO MD Online Portal.
• Responding promptly to any queries from CDSCO.

Note that no test license is required for import applications.

Import License Documents Required

Key documents for import license application include:

• Valid Manufacturing License of the device from the country of origin
• Free Sale Certificate indicating the device is marketed and sold freely abroad
• ISO 13485:2016 Certification
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale License for distribution in India
• Company Constitution documents

Timeline and Processing Duration

These timelines are indicative and depend on timely submission of documents and query resolution.

Government Fees and Costs

For Class B devices like the Endometrial Cytology Brush, the fee structure is as follows:

• MD5 License: Rs 5,000 per application + Rs 500 per product.
• Test License (MD13): Included in the process; fees apply separately.
• Import License (MD15): Approximate fee is $2,000 per site +$1,000 per product.

Budgeting for these fees upfront helps avoid unexpected delays.

Common Challenges and Practical Solutions

• Incomplete Documentation: Ensure all files, especially Device and Plant Master Files, are detailed and compliant. Our comprehensive guides can assist in preparation.
• Delayed Testing: Select government-approved labs early and schedule tests promptly.
• Audit Non-Compliance: Prepare thoroughly for audits by reviewing notified body requirements and conducting internal pre-audits.
• Query Resolution Delays: Assign a dedicated team member to respond swiftly and accurately to CDSCO queries.

Expert Consultation and Support

Navigating CDSCO licensing can be daunting. With our 25+ years of experience, we offer end-to-end consultancy—from document preparation to audit support and query management. Our expertise ensures accelerated approvals and regulatory compliance.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm your device's Class B status using resources like the Medical Device Classification.
2. Gather Preliminary Documents: Begin compiling company constitution, manufacturing site proof, and technical staff credentials.
3. Apply for Test License (MD13): Submit your test license application through the CDSCO MD Online Portal.
4. Schedule Product Testing: Coordinate with government-approved labs to initiate testing as soon as the test license is granted.
5. Prepare Technical Files: Develop your Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.
6. Plan for Audit: Contact notified bodies for audit scheduling and pre-audit guidance.
7. Submit Manufacturing License Application (MD3): Once testing and documentation are complete, apply for the MD5 license.

Embarking on this structured approach mitigates risks of delays and ensures your Endometrial Cytology Brush meets all regulatory benchmarks for successful entry into the Indian market.

For tailored assistance, reach out to our consulting experts with proven success in securing CDSCO licenses for Class B obstetrical and gynecological devices.