CDSCO License for Extractor

Comprehensive Guide to CDSCO Licensing for Extractor Devices (Class A Medical Devices)

As a trusted regulatory consultancy with over 25 years of experience and having supported 500+ manufacturers and importers, we understand the critical nuances involved in securing CDSCO licenses for Class A medical devices like the Extractor. This instrument, commonly known as a splinter probe, is essential in removing foreign objects from superficial skin tissue and is classified under General Hospital or Orthopaedic Instruments. With the official notification 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022, regulatory compliance is mandatory before entering the Indian market.

CDSCO Regulatory Framework for Extractor Devices

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India, classifying them based on risk. The Extractor, being a Class A device (low risk), falls under the ambit of the State Licensing Authority for manufacturing licenses but requires strict adherence to documentation, testing, and quality management to comply with Indian laws.

Risk Classification and License Requirements for Extractor

• Risk Class: A (Low risk)
• License Type: MD5 Manufacturing License (Application Form MD3)
• Regulatory Authority: State Licensing Authority
• Applicable Notification: 29/Misc./03/2020-DC (193)- Part-3

Class A devices like the Extractor require a MD5 license, which is a streamlined process compared to higher-risk classes but still demands comprehensive documentation and testing.

Manufacturing License Process (MD5) for Extractor Devices

1. Obtain Test License (MD13): Initiate with a Test License application for the device on Form MD13. This step allows you to conduct mandatory product testing.
2. Product Testing: Perform tests at CDSCO-recognized testing laboratories to validate safety and efficacy. Refer to the official Testing Laboratories list.
3. Document Preparation: Prepare all required documentation, including Device Master File, Plant Master File, Risk Management File, and QMS documents.
4. Submit Manufacturing License Application (Form MD3): Apply for the MD5 license through the CDSCO MD Online Portal.
5. Audit by Notified Body: A notified body from the official Notified Bodies list will conduct a facility audit.
6. Resolve Queries: Address any queries raised by the licensing authority or the notified body promptly.
7. Grant of License (Form MD5): Upon successful audit and documentation approval, the license is granted.

Manufacturing License Documents Required for Extractor Devices

• Company Constitution (Incorporation documents)
• Proof of ownership/lease of manufacturing premises
• Qualification and experience certificates of technical staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing product specifications and manufacturing processes
• Plant Master File (PMF) describing facility and equipment
• Essential Principles Checklist confirming compliance with Indian regulations
• Risk Management File outlining hazard analyses and mitigation strategies
• Test Reports from accredited laboratories
• Device labels, packaging, and Instructions for Use (IFU)
• Quality Management System (QMS) documentation (ISO 13485:2016 recommended)

Practical Tip: We recommend reviewing our detailed Device Master File guide and Plant Master File guide to ensure robust document preparation.

Import License Process (MD15) for Extractor Devices

While your Extractor device is Class A and primarily requires a manufacturing license for domestic production, importers must obtain an MD15 license (Import License) from the Central Licensing Authority.

Steps include:

• Document preparation including Manufacturing License, Free Sale Certificate, ISO 13485, CE certificate,
• Submission of application on Form MD14 through the CDSCO MD Online Portal
• Resolution of any regulatory queries
• Grant of MD15 Import License

Import License Documents Required

• Valid Manufacturing License (MD5 or MD9)
• Free Sale Certificate from the country of origin
• ISO 13485:2016 certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License
• Company Constitution

Timeline and Processing Duration for Extractor Licensing

• Test License (Form MD13): Approximately 1.5 to 2 months
• Product Testing: 2 to 3 weeks depending on lab capacity
• Manufacturing License (MD5): 3 to 4 months inclusive of audit and query resolution

Overall, manufacturers should anticipate a total timeline of 3 to 4 months before receiving the MD5 license for Extractor devices.

Government Fees and Costs

• MD5 Manufacturing License: Rs. 5,000 per application plus Rs. 500 per product
• Test License (MD13): Included in overall fees
• Product Testing: Variable, depending on test scope; typically Rs. 50,000 to Rs. 1,00,000
• Audit Fees: Generally borne by the notified body; varies by region and entity

Common Challenges and Practical Solutions

• Delayed Testing Results: Engage with accredited labs early and confirm testing schedules to avoid bottlenecks.
• Incomplete Documentation: Use detailed checklists and seek expert reviews to ensure all documents comply with CDSCO requirements.
• Audit Non-compliance: Prepare your facility and QMS thoroughly. Conduct internal audits prior to notified body visits.
• Query Resolution Delays: Designate a dedicated regulatory liaison to respond promptly to CDSCO queries.

Expert Consultation and Support

Our extensive experience with over 500 successful CDSCO licensing projects positions us uniquely to assist you with:

• Tailored document preparation
• Liaison with notified bodies and testing labs
• Pre-audit readiness assessments
• Application submission and follow-up
• Addressing post-submission queries efficiently

Getting Started with Your CDSCO License Application for Extractor Devices

1. Assess Your Product Classification: Confirm your Extractor device falls under Class A using the Medical Device Classification tool.
2. Register on the CDSCO MD Online Portal: Begin by creating your account at the CDSCO MD Online Portal.
3. Apply for Test License (MD13): Submit your application for the test license to initiate product testing.
4. Engage Accredited Testing Labs: Coordinate product testing early to avoid delays.
5. Prepare Comprehensive Documentation: Leverage our guides and templates to assemble your Device Master File, Plant Master File, and other critical documents.
6. Submit Manufacturing License Application (MD3): Once testing is complete and documents are ready, file your MD5 license application.
7. Plan for Audit and Compliance: Prepare your facility and documentation for the notified body audit.
8. Monitor Application Status: Track your application and respond swiftly to queries.

By following these steps and leveraging expert guidance, manufacturers and importers of Extractor devices can navigate the CDSCO licensing pathway efficiently, ensuring timely market access while maintaining compliance with Indian regulatory standards.

For detailed support and turnkey solutions, contact our regulatory consultancy team dedicated to medical device licensing in India.