CDSCO License for Endocervical aspirator

Comprehensive Guide to CDSCO Licensing for Endocervical Aspirators (Class C Medical Device)

As a trusted regulatory consultancy with over 25 years of experience and having successfully assisted 500+ companies in securing CDSCO licenses, we understand the complexities involved in bringing specialized medical devices like the Endocervical Aspirator to the Indian market. This device, classified under Class C, plays a crucial role in oncology by removing superficial tissue from the mucous membrane lining the cervical canal via manually-powered suction—a critical function in diagnostic and therapeutic gynecological care.

Navigating the CDSCO regulatory framework can be challenging for manufacturers and importers. Our detailed guide below provides practical insights, timelines, costs, and documentation specifics tailored precisely for the Endocervical Aspirator.

CDSCO Regulatory Framework for Endocervical Aspirators

The Central Drugs Standard Control Organization (CDSCO) governs the approval and licensing of medical devices in India. Since the Endocervical Aspirator falls under Class C (moderate to high risk), it is regulated stringently to ensure safety and efficacy.

This device is listed under the oncology category and notified under File No. 29/Misc./03/2020-DC (153) — Part 1, dated 11.10.2022, mandating compliance with CDSCO's centralized licensing process.

Risk Classification and License Requirements for Class C Devices

According to CDSCO’s classification, Class C devices require a manufacturing license known as the MD9 license. This license is issued by the Central Licensing Authority due to the higher risk associated with these devices.

The MD9 license process involves rigorous testing, documentation, and an onsite audit by CDSCO inspectors before the license is granted.

Our reference on medical device classification can help you verify your device class: Medical Device Classification.

Manufacturing License Process (MD9) for Endocervical Aspirators

Step 1: Obtain Test License (Form MD13)

Before applying for the MD9 manufacturing license, you must first secure a Test License via Form MD13. This license permits product testing at CDSCO-approved labs.

• Timeline: Approximately 1.5 to 2 months
• Key Action: Submit detailed device specifications, proposed manufacturing process, and quality management documents to CDSCO.

Step 2: Product Testing

The Endocervical Aspirator must undergo comprehensive testing at government-accredited laboratories to validate safety, performance, and compliance with applicable standards.

• Check the list of authorized testing facilities: Testing Laboratories

Step 3: Document Preparation

Prepare the following essential documents:

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualification and Experience
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF): Detailed design and manufacturing process information (Device Master File Guide)
• Plant Master File (PMF): Facility and quality management system details (Plant Master File Guide)
• Essential Principles Checklist demonstrating compliance with Indian standards
• Risk Management File following ISO 14971 principles (Risk Management Guide)
• Test Reports from accredited labs
• Device Labels and Instructions for Use (IFU)
• Quality Management System Documents (preferably ISO 13485:2016 certified)

Step 4: Apply for MD9 Manufacturing License (Form MD7)

Submit the complete application via the CDSCO MD Online Portal with the above documentation.

Step 5: CDSCO Inspection and Audit

Post-application, CDSCO inspectors will conduct an onsite audit of your manufacturing facility and review documentation to verify compliance.

Step 6: Respond to Queries

You may receive queries or requests for clarifications from CDSCO or the audit team. Timely and thorough responses help prevent delays.

Step 7: License Grant

Upon satisfactory compliance, you will be issued the MD9 manufacturing license on Form MD9.

For a detailed walkthrough, refer to our MD9 License Guide.

Manufacturing License Documents Required for Endocervical Aspirators

• Company Constitution/Registration Certificate
• Proof of Manufacturing Premises Ownership/Lease
• Technical Staff Details (CVs, Qualifications)
• Fire Department NOC
• Pollution Control Board NOC
• Device Master File (DMF)
• Plant Master File (PMF)
• Essential Principles Checklist
• Risk Management File
• Test Reports from CDSCO-Approved Labs
• Device Labels and Instructions for Use (IFU)
• Quality Management System Documentation (ISO 13485:2016 preferred)

Import License Process (MD15) for Endocervical Aspirators

If you are an importer rather than a manufacturer, you must apply for the MD15 import license granted by the Central Licensing Authority.

Key Steps for MD15:

• Prepare documents including your manufacturing license, Free Sale Certificate from the country of origin, ISO 13485:2016 certification, CE certificate, Device Master File, Plant Master File, Wholesale License, and Company Constitution.
• Submit application on the CDSCO MD Online Portal.
• Respond to any departmental queries.
• License processing typically takes 5 to 6 months.

For comprehensive guidance, see our Import License Guide.

Timeline and Processing Duration

This timeline assumes proactive communication and prompt responses to regulatory queries.

Government Fees and Costs

Note: The above fees are payable to CDSCO during the application process via the online portal.

Additional costs include:

• Testing fees at approved laboratories
• Notified body audit charges
• Documentation consultancy (optional but recommended)

Common Challenges and Practical Solutions

• Incomplete Documentation: Often delays arise from missing or inconsistent documentation. We recommend using standardized templates and checklists early in preparation.
• Delayed Testing Results: Coordinate closely with accredited labs and plan testing well ahead of license application.
• Audit Non-Compliance: Conduct internal mock audits before the official CDSCO inspection to ensure compliance.
• Query Management: Maintain a dedicated regulatory point person to respond promptly to CDSCO queries.

Expert Consultation and Support

With a strong track record supporting over 500 medical device companies, our regulatory experts provide end-to-end assistance—from dossier preparation, audit readiness, to liaison with CDSCO authorities.

Our tailored consulting services have expedited licensing for many oncology device manufacturers, including those specializing in gynecological instruments like the Endocervical Aspirator.

Getting Started with Your CDSCO License Application

1. Evaluate Your Device Classification: Confirm that your Endocervical Aspirator is Class C.
2. Prepare Test License Application: Initiate the MD13 test license application on the CDSCO MD Online Portal.
3. Engage Accredited Labs: Schedule product testing with government-approved laboratories.
4. Collect and Organize Documentation: Use our Device Master File Guide and Plant Master File Guide to compile comprehensive files.
5. Plan for Audit: Prepare your facility and quality systems ahead of CDSCO inspection.
6. Submit MD9 Application: Once test reports and documents are ready, apply on the CDSCO portal.

Embarking on this process with detailed planning and expert guidance ensures smoother compliance and faster market entry. Contact us to initiate your licensing journey or for personalized regulatory support tailored to your Endocervical Aspirator product.

For deeper insights, visit the official CDSCO MD Online Portal and explore our resource guides linked throughout this page.