CDSCO License for Heel stirrup

Comprehensive Guide to CDSCO Licensing for Heel Stirrup: Class A Medical Device

The Heel Stirrup, classified as a Class A medical device under the Obstetrical and Gynecological category, plays a critical role in surgical procedures by securely holding a patient’s foot. Given its medical application and classification, obtaining the appropriate CDSCO license is mandatory for legal manufacturing and marketing in India. With over 25 years of regulatory consulting experience and successful facilitation of licenses for 500+ medical device companies, we provide a detailed walkthrough to help manufacturers and importers navigate the CDSCO licensing process efficiently.

CDSCO Regulatory Framework for Heel Stirrup

The Central Drugs Standard Control Organization (CDSCO) governs the licensing of medical devices in India under the Medical Devices Rules, 2017. The Heel Stirrup falls under Class A (Low Risk) as per the Medical Device Classification, making the MD5 license applicable.

The regulatory framework mandates manufacturers to obtain a manufacturing license from the State Licensing Authority. Our team advises early engagement with CDSCO’s MD Online Portal for application submission and tracking.

Risk Classification and License Requirements for Heel Stirrup

• Device Name: Heel Stirrup
• Risk Class: A (Low Risk)
• Intended Use: To hold a patient’s foot securely during medical/surgical procedures
• Category: Obstetrical and Gynecological
• Regulatory Notification: File No. 29/Misc./03/2020-DC (181), dated 03.06.2022

As a Class A device, the Heel Stirrup requires an MD5 manufacturing license (Form MD3) granted by the State Licensing Authority. The process includes obtaining a Test License (Form MD13), product testing, document preparation, audit by a notified body, and final license issuance.

Manufacturing License Process (MD5) for Heel Stirrup

1. Test License Application (MD13): Begin by applying for a Test License through the CDSCO MD Online Portal. This is mandatory before product testing, with a processing timeline of approximately 1.5 to 2 months.

2. Product Testing: Conduct product testing at CDSCO-approved laboratories. Refer to the list of Testing Laboratories to select an authorized lab. Testing typically involves compliance with Essential Principles and safety standards.

3. Document Preparation: Compile all required technical documents, including Device Master File, Plant Master File, Risk Management File, and Quality Management System documentation.

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

5. Audit by Notified Body: Coordinate with a notified body for an on-site audit of your manufacturing facility. Check the list of notified bodies for authorized auditors experienced with Class A devices.

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

7. License Grant: Upon successful audit and query resolution, the MD5 manufacturing license (Form MD5) is granted.

For an in-depth walkthrough, you can refer to our MD5 License Guide.

Manufacturing License Documents Required for Heel Stirrup

Ensure the following documents are prepared meticulously to avoid delays:

• Company Constitution/Registration Certificates
• Proof of Ownership or Lease of Manufacturing Premises
• Qualification and Experience Documents of Technical Staff
• Fire NOC and Pollution Control NOC
• Device Master File (DMF) detailing product specifications and design (Device Master File Guide)
• Plant Master File describing the manufacturing facility (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with safety and performance requirements
• Risk Management File demonstrating hazard identification and mitigation (Risk Management)
• Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents, preferably ISO 13485:2016 certified

Import License Process (MD15) for Heel Stirrup

For importers of the Heel Stirrup, an MD15 import license from the Central Licensing Authority is necessary. The process takes approximately 5-6 months and involves:

• Preparing and submitting the application in Form MD14 via the CDSCO MD Online Portal
• Providing documents like the manufacturing license from the country of origin, Free Sale Certificate, ISO certification, CE certificate, Device and Plant Master Files, Wholesale License, and Company Constitution
• Resolving any departmental queries

The import license fees vary by risk class, and for Class A devices, the site fee is approximately $1000 with$50 per product.

For detailed guidance, consult our Import License Guide.

Timeline and Processing Duration for Heel Stirrup Licensing

• Test License (MD13): 1.5 to 2 months
• Product Testing: 3 to 6 weeks depending on lab workload
• Manufacturing License (MD5): 1 to 1.5 months post-audit and document submission

Total estimated timeline: Approximately 3 to 4 months from start to finish.

Government Fees and Costs

• Test License (MD13): Rs. 5000 approx.
• MD5 License Application Fee: Rs. 5000 per application
• Product Fee: Rs. 500 per product
• Audit Fees: Charged by notified bodies separately, typically ranging from Rs. 30,000 to Rs. 50,000 depending on the scope

Budgeting for notified body audit fees and potential re-submission or query handling delays is essential.

Common Challenges and Solutions

• Delayed Product Testing: Ensure early booking with CDSCO-approved labs and confirm test parameters to avoid re-testing.
• Incomplete Documentation: Utilize checklists and expert review to ensure all documents like Device Master File and Risk Management File are robust.
• Audit Non-Compliance: Prepare your manufacturing facility and QMS rigorously. Conduct internal audits before notified body visits.
• Query Resolution Delays: Respond promptly with clear, well-supported answers. Maintaining a direct liaison with CDSCO officials can expedite this.

Expert Consultation and Support

With over two decades of regulatory expertise and over 500 successful CDSCO licensing projects, our consultancy offers tailored support for Heel Stirrup manufacturers and importers. We assist with document preparation, audit readiness, liaison with notified bodies, and application submission to minimize delays and enhance approval chances.

Getting Started with Your CDSCO License Application for Heel Stirrup

1. Register on the CDSCO MD Online Portal: This is your gateway for all applications and tracking.
2. Assess your manufacturing setup: Gather all infrastructure-related documents and conduct a gap analysis.
3. Engage an approved testing laboratory early: Select from the CDSCO-approved Testing Laboratories to schedule product testing.
4. Prepare Device and Plant Master Files: These are critical for audit and must accurately reflect your operations.
5. Apply for Test License (MD13): Initiate the process to avoid downstream delays.
6. Schedule the audit with a notified body: Choose from the notified bodies list and book your audit slot.

Starting early and following a structured approach reduces risks of rejection and expedites market entry for your Heel Stirrup device.

For personalized assistance, reach out to our regulatory experts who guide you through each step from documentation to license issuance.