CDSCO License for Sacroiliac joint fixation

Comprehensive Guide to CDSCO Licensing for Sacroiliac Joint Fixation Devices (Class C Orthopaedic Implants)

With over 25 years of experience assisting 500+ medical device companies, we understand the complexities involved in obtaining CDSCO licenses for high-risk devices like sacroiliac joint fixation implants. These devices, classified as Class C under CDSCO regulations, play a critical role in protecting the lumbosacral region by stabilizing the sacroiliac joints. This guide offers detailed insights into the regulatory framework, licensing process, timelines, costs, and practical tips to help manufacturers and importers navigate CDSCO approvals efficiently.

CDSCO Regulatory Framework for Sacroiliac Joint Fixation Devices

The Central Drugs Standard Control Organization (CDSCO) governs the regulation of medical devices in India, classifying devices into four risk classes: A, B, C, and D. Sacroiliac joint fixation devices fall under Class C due to their implantable nature and higher risk profile. The governing notification for this device is 29/Misc/3/2017-DC (292), dated 06.06.2018, which officially recognizes it under Indian medical device regulations.

Since this is a Class C device, the license is issued by the CDSCO Central Licensing Authority, requiring adherence to stringent documentation, testing, and audit protocols.

Risk Classification and License Requirements for Class C Devices

• Risk Class: C (moderate to high risk)
• License Type: Manufacturing License MD9 (Application Form MD7)
• Authority: Central Licensing Authority, CDSCO
• Process Overview: Includes obtaining a Test License (Form MD13), product testing from government-approved labs, document submission, CDSCO audit, and resolution of queries.

For more on device classification, visit our detailed Medical Device Classification guide.

Manufacturing License Process (MD9) for Sacroiliac Joint Fixation Devices

1. Test License Application (Form MD13): The initial step involves applying for a test license to legally manufacture the device for testing purposes. This phase typically takes 1.5 to 2 months.

2. Product Testing: Samples must be tested in CDSCO-approved government laboratories. Refer to the current Testing Laboratories list to select an authorized lab.

3. Document Preparation: Comprehensive documentation including technical files, quality management systems, and compliance evidence must be assembled.

4. License Application (Form MD7): Submit the manufacturing license application through the CDSCO MD Online Portal.

5. CDSCO Audit: Post submission, the CDSCO authorities conduct an on-site audit of the manufacturing facility and quality systems.

6. Resolution of Queries: Address any observations or queries raised by the CDSCO or audit team promptly to avoid delays.

7. Grant of MD9 License: Upon satisfactory review and audit, the manufacturing license is granted on Form MD9.

For an in-depth walkthrough, our MD9 License Guide provides expert tips and document templates.

Manufacturing License Documents Required for MD9

For sacroiliac joint fixation devices, the following documents are mandatory:

• Company Constitution: Legal documents establishing the entity.
• Proof of Ownership/Lease of Premises: To confirm manufacturing site legitimacy.
• Technical Staff Qualifications: CVs and certificates of key personnel.
• Fire and Pollution NOCs: Compliance certificates from local authorities.
• Device Master File: Detailed device specifications, design, and manufacturing processes. Learn how to prepare it in our Device Master File Guide.
• Plant Master File: Documentation of manufacturing environment and controls. See our Plant Master File Guide.
• Essential Principles Checklist: Demonstrating compliance with Indian regulatory standards.
• Risk Management File: Evaluation and mitigation of device risks, crucial for implants. Our Risk Management resource offers practical insights.
• Test Reports: Validated reports from CDSCO-approved labs.
• Product Labels and Instructions for Use (IFU): Clear and compliant labeling.
• Quality Management System Documents: Typically ISO 13485:2016 certification and supporting SOPs.

Import License Process (MD15) for Sacroiliac Joint Fixation Devices

If importing sacroiliac joint fixation devices, an Import License (MD15) from CDSCO is required, issued by the Central Licensing Authority. The process spans approximately 5 to 6 months and includes:

• Preparing and submitting the application on the CDSCO MD Online Portal.
• Providing comprehensive documentation such as manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE certificate, Device and Plant Master Files, and wholesale license.
• Addressing queries raised by CDSCO during the review.

Detailed guidance is available in our Import License Guide.

Import License Documents Required

• Valid Manufacturing License of the foreign manufacturer
• Free Sale Certificate from the country of origin
• ISO 13485:2016 Certificate
• CE Certificate or equivalent regulatory approval
• Device Master File and Plant Master File
• Wholesale License (if applicable)
• Company Constitution and Importer’s authorization letter

Timeline and Processing Duration

The import license (MD15) process generally takes about 5 to 6 months.

Government Fees and Costs

• MD9 Manufacturing License Fees:

  • Application Fee: INR 50,000
  • Per Product Fee: INR 1,000

• Test License (MD13) Fee: Included in application fees

• Import License (MD15) Fees:

  • Class C Devices: USD 3,000 per site + USD 1,500 per product

These fees are payable online via the CDSCO MD Online Portal.

Common Challenges and Solutions

• Challenge: Delays due to incomplete or inconsistent documentation

  • Solution: Engage expert consultants early to review and prepare documents meticulously.

• Challenge: Extended timelines due to audit observations

  • Solution: Conduct internal mock audits and gap assessments prior to CDSCO inspections.

• Challenge: Product testing failures or delays

  • Solution: Select experienced CDSCO-approved labs listed here and ensure product samples meet specifications.

• Challenge: Navigating complex query resolutions

  • Solution: Maintain clear communication and provide prompt, evidence-backed responses.

Expert Consultation and Support

Our team has successfully guided over 500 companies through the CDSCO licensing maze, specializing in Class C orthopaedic implants such as sacroiliac joint fixation devices. We offer:

• End-to-end regulatory consulting
• Document preparation and review
• Audit readiness support
• Product testing coordination
• Post-approval regulatory compliance

Contact us for personalized assistance to avoid costly delays and ensure compliance.

Getting Started with Your CDSCO License Application

1. Identify the Regulatory Path: Confirm your device’s classification as Class C and determine if you require a manufacturing or import license.

2. Register on the CDSCO MD Online Portal: Begin by creating your account and familiarizing yourself with the interface at the CDSCO MD Online Portal.

3. Prepare and Submit Test License (Form MD13): If manufacturing, apply for the test license promptly to initiate product testing.

4. Gather Required Documents: Use this guide and our linked resources to compile all necessary files, including Device and Plant Master Files.

5. Engage a CDSCO-Approved Testing Laboratory: Coordinate sample testing early to avoid bottlenecks.

6. Schedule Internal Audits: Ensure compliance with quality and regulatory requirements before CDSCO inspections.

7. Submit Manufacturing License Application (Form MD7) or Import License Application (Form MD14): Follow up regularly on application status and promptly address any queries.

By taking these proactive steps, you can significantly streamline the licensing process for your sacroiliac joint fixation device and bring your innovative orthopaedic implant to the Indian market successfully.

For further tailored assistance, reach out to our expert consultants who have a proven track record in CDSCO licensing for orthopaedic implants.