CDSCO License for Battery-powered trephine system

Introduction to Battery-powered Trephine System and Regulatory Importance

The Battery-powered trephine system is a precision rotary surgical device designed primarily for dermatological and plastic surgery applications. Featuring a sharp-edged, beveled saw blade powered by a battery-driven motor, it facilitates the removal of intervertebral discs and various hard or soft tissues with controlled speed settings. Given its direct surgical application and invasive nature, regulatory compliance through the Central Drugs Standard Control Organization (CDSCO) is essential. Ensuring adherence to CDSCO regulations not only guarantees patient safety but also smooth market entry and sustained business growth within India.

CDSCO Regulatory Framework for Battery-powered Trephine System

As per the CDSCO’s regulatory mandate, medical devices are classified based on risk and intended use. The Battery-powered trephine system falls under Class B (Low Risk), as indicated by Notification 29/Misc./03/2020-DC (147) dated 26.7.2021. This classification places it under the category of devices requiring a manufacturing license known as the MD5 License.

The licensing process is overseen by the State Licensing Authority, with key steps including product testing, documentation, audit, and final approval via the CDSCO MD Online Portal.

Risk Classification and License Requirements

• Device Risk Class: B (Low Risk)
• Regulatory License: MD5 Manufacturing License (Form MD3)
• Licensing Authority: State Licensing Authority
• Applicable Rules: Medical Device Rules, 2017

Class B devices like the Battery-powered trephine system require a comprehensive compliance approach, including product testing in government-approved laboratories and a mandatory audit by a notified body. The audit ensures that manufacturing practices meet quality and safety standards.

Manufacturing License Process (MD5)

The MD5 license process is methodical and typically spans 3 to 4 months. Here’s the stepwise procedure:

1. Test License (Form MD13): Initially, manufacturers must apply for a test license, valid for 12 months, to legally produce and test the device. This stage takes approximately 1.5 to 2 months.

2. Laboratory Testing: The device samples are submitted to CDSCO-recognized testing laboratories. You can review the list of authorized testing labs. Testing validates that the device adheres to applicable safety and performance standards.

3. Documentation Preparation: Detailed documentation, including Device Master File and Plant Master File, must be prepared. Our comprehensive Device Master File guide and Plant Master File guide are invaluable resources.

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

5. Audit by Notified Body: The State Licensing Authority will appoint a notified body from the official list of notified bodies to conduct an on-site 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 manufacturing license will be granted.

Manufacturing License Documents Required

For the Battery-powered trephine system, the following documents are mandatory:

• Certificate of Incorporation and Company Constitution
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualification and Experience Details
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing design, specifications, and manufacturing process
• Plant Master File (PMF) outlining facility and equipment
• Essential Principles Checklist demonstrating compliance with Medical Device Rules
• Risk Management File highlighting hazard analysis and mitigation strategies
• Test Reports from government-approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation (preferably ISO 13485:2016 compliant)

Import License Process (MD15)

For importers of the Battery-powered trephine system, an MD15 Import License is required, granted by the Central Licensing Authority. The process generally takes 5 to 6 months and involves:

• Preparing comprehensive documentation, including the manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE certificate (if applicable), and detailed device dossiers.
• Submission of Form MD14 for import license application.
• Query resolution and final approval.

Refer to our detailed Import License guide for in-depth insights.

Import License Documents Required

Key documents for import license application include:

• Valid Manufacturing License from the country of origin
• Free Sale Certificate issued by the regulatory authority of the exporting country
• ISO 13485:2016 Certification
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale License (if applicable)
• Company Constitution and Ownership Proof

Timeline and Processing Duration

Government Fees and Costs

For a Class B device like the Battery-powered trephine system, the fee structure is as follows:

• MD5 Manufacturing License:
  • Application Fee: Rs. 5,000
  • Per Product Fee: Rs. 500
• Test License (MD13): Included within the MD5 application process

These fees are payable via the CDSCO MD Online Portal.

Common Challenges and Solutions

• Delays in Testing: Government labs may have backlogs; planning early submission and selecting labs with shorter lead times can mitigate this.

• Incomplete Documentation: Missing or poorly compiled files often cause rejections. Utilize our detailed guides on Device Master Files and Plant Master Files to ensure completeness.

• Audit Non-Compliance: Prepare thoroughly by aligning your QMS and facility with notified body expectations. Schedule pre-audit mock inspections to identify gaps.

• Query Resolution Delays: Assign dedicated personnel for rapid responses to CDSCO queries to avoid procedural delays.

Expert Consultation and Support

With over 25 years of experience and having supported 500+ manufacturers and importers, we offer tailored consultancy to navigate CDSCO licensing seamlessly. From documentation preparation to audit readiness and query management, our expert team minimizes risks and accelerates approvals. Leveraging our insights can save months of potential delays and ensure regulatory compliance.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your device as Class B per Medical Device Classification.

2. Register on CDSCO MD Online Portal: Create your account and familiarize yourself with the platform.

3. Engage a Testing Laboratory: Choose a government-approved lab early to schedule product testing.

4. Prepare Documentation: Start compiling your Device Master File, Plant Master File, risk management files, and QMS documents.

5. Apply for Test License (MD13): Submit your application to legally initiate device manufacturing and testing.

6. Plan for Audit: Coordinate with a notified body from the notified bodies list for audit scheduling.

7. Submit Manufacturing License Application (MD5): Once testing and audit are complete, file your application with complete documentation.

8. Monitor and Respond to Queries: Track your application status on the portal and respond promptly to any CDSCO or audit queries.

Starting early, maintaining meticulous records, and leveraging expert guidance are key to a successful licensing journey for your Battery-powered trephine system in India.