CDSCO License for Shaver System

Comprehensive Guide to CDSCO Licensing for Shaver System (Class B Medical Device)

As seasoned regulatory consultants with over 25 years of experience and a track record of assisting 500+ companies, we understand the complexities involved in obtaining a CDSCO license for medical devices like the Shaver System. This surgical device, intended for the resection of soft and osseous tissues during procedures, falls under the Class B risk category within the general hospital or orthopaedic instruments category, as per the CDSCO Notification 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022.

CDSCO Regulatory Framework for Shaver Systems

The Central Drugs Standard Control Organization (CDSCO) governs the import, manufacture, and sale of medical devices in India. For devices like the Shaver System, which are categorized as Class B (low to moderate risk), the regulatory pathway requires obtaining an MD5 manufacturing license or an MD15 import license depending on whether you are a manufacturer or importer.

The regulatory requirements are designed to ensure the safety and efficacy of the device for its intended surgical use. Compliance with these standards is mandatory before the device can be marketed in India.

Risk Classification and License Requirements

The Shaver System is classified as a Class B medical device. This classification implies:

• Moderate risk associated with the device’s use.
• Requires an MD5 license for manufacturing (issued by the State Licensing Authority).
• Requires an MD15 import license for importers (issued by the Central Licensing Authority).

You can verify and understand device classification through resources like our Medical Device Classification guide.

Manufacturing License Process (MD5) for Shaver System

For manufacturers intending to produce the Shaver System in India, the MD5 license process involves several critical steps:

1. Test License Application (Form MD13): Obtain a test license to conduct product testing. This step typically takes 1.5 to 2 months.

2. Product Testing: Get your Shaver System tested at CDSCO-approved laboratories. Refer to the official list of Testing Laboratories.

3. Documentation Preparation: Prepare essential documents including Device Master File, Plant Master File, Risk Management File, and others (detailed below).

4. License Application (Form MD3): Submit your MD5 license application via the CDSCO MD Online Portal.

5. Audit by Notified Body: An audit is conducted by a notified body listed in the Notified Bodies List for MD5 Audit.

6. Query Resolution: Address any queries raised by the CDSCO or the notified body promptly.

7. Grant of License (Form MD5): Upon satisfactory compliance, the license is granted.

The entire process generally takes about 3 to 4 months, including testing and audit phases.

For detailed guidance, consult our MD5 License Guide.

Manufacturing License Documents Required

To ensure successful application processing, prepare the following documentation meticulously:

• Company Constitution Documents (Incorporation Certificate, Memorandum & Articles of Association)
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Technical Staff Credentials (Qualifications and experience of manufacturing and quality personnel)
• Fire and Pollution NOCs
• Device Master File (DMF) – Detailed design and manufacturing process documentation. Our Device Master File guide provides comprehensive insights.
• Plant Master File (PMF) – Facility details, equipment, and quality systems. Refer to our Plant Master File Guide.
• Essential Principles Checklist – Demonstrating compliance with Indian regulatory standards.
• Risk Management File – Risk analysis and mitigation strategies. Learn more about Medical Device Risk Management.
• Test Reports from CDSCO-approved labs
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents (typically ISO 13485:2016 certified)

Import License Process (MD15) for Shaver System

Importers wishing to bring the Shaver System into India must obtain an MD15 import license granted by the Central Licensing Authority. The process is as follows:

1. Document Preparation including Manufacturing License from country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, and other relevant licenses.

2. Application Submission on Form MD14 via the CDSCO MD Online Portal.

3. Query Resolution: Respond promptly to any queries from CDSCO.

4. Grant of License (Form MD15)

The process generally takes 5 to 6 months.

Full details on import licensing can be found in our Import License Guide.

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 and Plant Master File
• Wholesale License (if applicable)
• Company Constitution Documents

Timeline and Processing Duration

Government Fees and Costs

For the Shaver System (Class B device), the fee structure is as follows:

• MD5 Manufacturing License:

  • Rs 5,000 per application
  • Rs 500 per product

• MD15 Import License:

  • Rs 2,000 per site
  • Rs 1,000 per product

These fees are payable via the CDSCO portal during application submission.

Common Challenges and Solutions

Challenge 1: Delays in Product Testing

• Solution: Engage early with CDSCO-approved laboratories and pre-book testing slots. Maintain clear communication to avoid bottlenecks.

Challenge 2: Incomplete Documentation

• Solution: Use detailed checklists and templates for Device Master File, Risk Management File, and Plant Master File. Our guides linked above provide practical templates.

Challenge 3: Audit Readiness

• Solution: Perform internal audits based on notified body requirements before the official audit. Document all quality processes meticulously.

Challenge 4: Query Resolution Delays

• Solution: Assign a dedicated regulatory officer for prompt and precise responses to CDSCO queries.

Expert Consultation and Support

Navigating CDSCO licensing can be daunting. With our extensive experience supporting over 500 companies, we offer:

• Comprehensive pre-submission reviews
• Gap analysis of technical documentation
• Audit preparedness training
• End-to-end application management

Our goal is to reduce your time to market and ensure compliance with minimal hassle.

Getting Started with Your CDSCO License Application for Shaver System

1. Assess Your Device Classification: Confirm your Shaver System is Class B.

2. Prepare Initial Documentation: Gather company, technical, and product data.

3. Apply for Test License (if manufacturing): Submit Form MD13 through the CDSCO MD Online Portal.

4. Schedule Testing at Approved Labs: Coordinate with listed testing laboratories for timely analysis.

5. Prepare Device and Plant Master Files: Use our comprehensive guides to ensure completeness.

6. Engage a Notified Body: Schedule audits early to align with your timeline.

7. Submit Application for MD5 License (Manufacturing) or MD15 License (Import): Complete your application with all supporting documents online.

8. Monitor Application Progress and Respond to Queries: Stay proactive to avoid delays.

By following these actionable steps and leveraging expert support, you can secure your CDSCO license for the Shaver System efficiently and compliantly, enabling you to serve the Indian healthcare market with confidence.