CDSCO License for Depth Gauge

Introduction to Depth Gauge and Its Regulatory Importance

The Depth Gauge is a Class A medical device designed to assist surgeons in accurately determining the appropriate length of retractor blades during orthopedic or general hospital procedures. Using a simple yet effective color-coded system, this instrument enhances surgical precision and patient outcomes. Given its pivotal role, regulatory compliance with the Central Drugs Standard Control Organization (CDSCO) in India is mandatory before the device can be manufactured or marketed.

Navigating the CDSCO licensing process can be complex, especially for first-time manufacturers or importers. With over 25 years of experience and having supported 500+ companies, we provide clear, actionable guidance on securing the necessary approvals for your Depth Gauge.

CDSCO Regulatory Framework for Depth Gauge (Class A Device)

The CDSCO governs medical devices under the Medical Device Rules, 2017, categorizing devices by risk class. Your Depth Gauge falls under Class A (low risk) and is notified under the notification 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022.

As a Class A device, the regulatory oversight is managed primarily by the State Licensing Authority. Manufacturers need to obtain an MD5 manufacturing license to legally produce this device in India.

Risk Classification and License Requirements for Depth Gauge

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

For detailed classification and risk management, manufacturers should consult the Medical Device Classification guide and implement robust Risk Management processes.

Manufacturing License Process for Depth Gauge (MD5)

The MD5 license process is a multi-step procedure involving:

1. Test License Application (Form MD13): Before the MD5 license, you must obtain a test license that permits sample production and testing. This takes approximately 1.5 to 2 months.

2. Product Testing: Conduct testing of the Depth Gauge at CDSCO-approved labs. Use the Testing Laboratories list to select a government-recognized facility.

3. Document Compilation: Prepare comprehensive technical documentation including Device Master File, Plant Master File, and Essential Principles Checklist.

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

5. Audit by Notified Body: The device manufacturing site undergoes an audit by a notified body. Check the list of notified bodies for authorized auditors.

6. Queries and Clarifications: Respond promptly to any queries raised by the department or notified body.

7. Grant of License: Upon satisfactory review, the MD5 license is issued.

Total processing time is typically 3 to 4 months, depending on audit scheduling and query resolution.

Manufacturing License Documents Required for Depth Gauge

To ensure a smooth application, prepare the following:

• Constitution of the company (e.g., Memorandum of Association, Articles of Association)
• Proof of ownership or lease of manufacturing premises
• Details and qualifications of technical staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF): Detailed design and technical data (Device Master File guide)
• Plant Master File (PMF): Manufacturing processes and quality systems (Plant Master File guide)
• Essential Principles Compliance Checklist
• Risk Management File
• Test Reports from CDSCO-approved labs
• Product labels and Instructions for Use (IFU)
• Quality Management System documentation (e.g., ISO 13485 certificates)

Ensuring these documents are detailed and compliant reduces back-and-forth during the audit.

Import License Process for Depth Gauge (MD15)

If you plan to import the Depth Gauge into India, an MD15 import license is required, issued by the Central Licensing Authority. Unlike manufacturing, no test license is needed.

Process:

1. Prepare all required documents (see next section).
2. Submit application on the CDSCO MD Online Portal.
3. Address any queries raised by the department.
4. License is granted within approximately 5 to 6 months.

Import License Documents Required for Depth Gauge

The import license application must include:

• Valid manufacturing license from the country of origin
• Free Sale Certificate
• ISO 13485:2016 certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License in India
• Constitution of the company

Note the higher scrutiny for imports, requiring extensive documentation.

Timeline and Processing Duration

Planning your regulatory submissions well in advance is critical for timely market entry.

Government Fees and Costs for Depth Gauge Licensing

• MD5 Manufacturing License:
  • Rs 5,000 per application
  • Rs 500 per product (Depth Gauge)

Given your single product, expect a total fee around Rs 5,500.

• Test License (MD13): No separate fees beyond administrative charges.

• Import License (MD15): Fees vary by class. For Class A devices, the equivalent fee is approximately $1,000 per site plus$50 per product.

Budgeting accurately for these fees avoids unexpected delays.

Common Challenges and Solutions

• Delayed Lab Testing: Choose CDSCO-approved labs early and book slots promptly.
• Incomplete Documentation: Use checklists and expert reviews to ensure completeness.
• Audit Scheduling Conflicts: Engage notified bodies early; maintain open communication.
• Query Resolution Delays: Assign dedicated personnel to respond quickly and comprehensively.

We recommend consulting experienced regulatory professionals to navigate these hurdles efficiently.

Expert Consultation and Support

With over 25 years of expertise and over 500 successful CDSCO license applications, we offer:

• End-to-end regulatory consulting
• Document preparation and review
• Coordination with notified bodies and testing labs
• Post-license compliance support

Our proven methodology minimizes processing time and maximizes approval success rates.

Getting Started with Your CDSCO License Application for Depth Gauge

To kickstart your CDSCO licensing journey:

1. Register your company on the CDSCO MD Online Portal.
2. Gather and prepare your technical documentation, including Device and Plant Master Files.
3. Apply for the Test License (MD13) to enable sample production and testing.
4. Schedule product testing at CDSCO-approved laboratories.
5. Plan and prepare for the notified body audit by reviewing the audit checklist.
6. Submit your MD5 license application (Form MD3) via the portal once test reports and audit preparations are complete.

Starting early and following these steps systematically will ensure your Depth Gauge reaches the Indian market without regulatory hindrance.

For personalized assistance and a detailed roadmap tailored to your manufacturing or import plans, contact us today.