CDSCO License for Tamp, Surgical

Comprehensive Guide to CDSCO Licensing for Surgical Tamp (Class A Medical Device)

Navigating the regulatory landscape for medical devices in India can be complex, especially for manufacturers and importers aiming to launch their products smoothly. With over 25 years of expertise and having assisted 500+ companies, we provide a detailed, practical roadmap for obtaining CDSCO licensing for the Surgical Tamp — a Class A medical device.

Introduction: Understanding Surgical Tamp and Its Regulatory Significance

A Surgical Tamp is a specialized instrument inserted into the disc space during spinal surgeries to pack bone grafts or substitutes. Importantly, it is not an implantable device but a surgical tool falling under the category of General Hospital or Orthopaedic Instruments. As per the CDSCO Notification 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022, this device is classified as Class A, the lowest risk category.

Despite its low-risk classification, strict regulatory compliance is crucial to ensure safety, quality, and market acceptance in India.

CDSCO Regulatory Framework for Class A Medical Devices like Surgical Tamp

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices through specific licensing frameworks. For Class A devices, the manufacturing license is governed by the State Licensing Authority under the MD5 license regime using Form MD3.

The process includes obtaining a test license (Form MD13), product testing at government-approved labs, document submission, audit by notified bodies, and final license grant.

Risk Classification and License Requirements for Surgical Tamp

• Risk Class: A (Low risk)
• Applicable License: MD5 Manufacturing License (Form MD3)
• Regulatory Authority: State Licensing Authority

Class A devices like the Surgical Tamp require fewer regulatory hurdles compared to higher-risk devices but still mandate compliance with essential principles, quality systems, and product testing.

Manufacturing License Process (MD5) for Surgical Tamp

1. Obtain Test License (Form MD13): Before manufacturing, apply for and secure a test license, which allows limited production to facilitate product testing.
2. Product Testing: Submit samples to CDSCO-approved testing laboratories to validate safety and performance. A list of testing laboratories is available on the CDSCO portal.
3. Document Preparation: Compile comprehensive documentation covering technical, quality, and compliance aspects.
4. Apply for MD5 License (Form MD3): Submit your application via the CDSCO MD Online Portal.
5. Audit by Notified Body: Engage a notified body listed here for an on-site audit of manufacturing premises and quality systems.
6. Query Resolution: Address any queries raised by the licensing authority or notified body promptly.
7. License Grant: Upon successful audit and compliance, the MD5 license is granted, enabling full-scale manufacturing.

Manufacturing License Documents Required for Surgical Tamp

For MD5 application, prepare the following key documents:

• Company Constitution (Incorporation Certificate, Partnership Deed, etc.)
• Proof of Ownership or Lease of Manufacturing Premises
• Qualification and Experience Certificates of Technical Staff
• Fire and Pollution NOCs
• Device Master File (DMF) detailing design, specifications, and manufacturing process (Device Master File Guide)
• Plant Master File (PMF) outlining manufacturing facilities and equipment (Plant Master File Guide)
• Essential Principles Compliance Checklist
• Risk Management File documenting hazard analysis and mitigation (Risk Management)
• Product Test Reports from approved labs
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents (preferably ISO 13485 compliant)

Import License Process (MD15) for Surgical Tamp

While the Surgical Tamp is primarily subject to manufacturing licensing, importers must secure an MD15 Import License if bringing devices into India.

Key steps include:

• Document preparation including manufacturing license, CE Certificate, ISO 13485:2016, Free Sale Certificate, Device and Plant Master Files
• Application submission on the CDSCO MD Online Portal
• Query resolution and final approval

Refer to our detailed Import License Guide for specifics.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Marking Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale License (if applicable)
• Company Constitution Documents

Timeline and Processing Duration

• Test License (Form MD13): Approximately 1.5 to 2 months
• Product Testing: 3 to 4 weeks, depending on laboratory workload
• MD5 License Application to Grant: 1.5 to 2 months post-audit

Total Estimated Time: Around 3 to 4 months from start to finish

Government Fees and Costs

• Test License Fee: Included in the overall process
• MD5 Manufacturing License Fee: Rs. 5,000 per application plus Rs. 500 per product
• Testing Charges: Variable depending on testing lab and tests required
• Notified Body Audit Fees: Typically additional, varies by auditor

Budgeting for these costs upfront ensures smoother cash flow and project planning.

Common Challenges and Practical Solutions

• Delayed Testing Results: Plan sample submission well in advance and choose accredited laboratories with shorter lead times.
• Incomplete Documentation: Use checklists and expert review to avoid rejection or queries.
• Audit Non-conformities: Conduct internal pre-audit assessments to prepare your site and QMS.
• Query Resolution Delays: Assign a dedicated regulatory liaison to respond promptly to CDSCO and notified body communications.

Expert Consultation and Support

Navigating CDSCO regulations requires nuanced understanding and meticulous preparation. Engaging consultants with proven experience can accelerate approvals and help avoid costly pitfalls. We offer end-to-end support from documentation, test license application, product testing coordination, audit preparation, to final license grant.

Getting Started with Your CDSCO License Application for Surgical Tamp

1. Assess Product Classification: Confirm your device is Class A as per CDSCO Notification dated 16.03.2022.
2. Gather Required Documents: Begin by compiling company, technical, and quality system documents.
3. Apply for Test License (Form MD13): Submit via the CDSCO MD Online Portal.
4. Plan Product Testing: Coordinate with approved labs early.
5. Prepare Device and Plant Master Files: Utilize our detailed guides to create compliant documentation.
6. Schedule Notified Body Audit: Contact notified bodies for audit planning.
7. Submit MD5 License Application: Once testing and documentation are complete.

Embarking on this structured approach aligns your Surgical Tamp manufacturing with CDSCO norms, facilitating a successful market entry. For personalized assistance or to discuss your specific case, contact our regulatory experts today.

For more detailed insights and regulatory updates, visit the CDSCO MD Online Portal and explore our comprehensive resources.