CDSCO License for Radiographic  head holder

Comprehensive Guide to CDSCO Licensing for Radiographic Head Holder (Class A Medical Device)

Introduction: Understanding Radiographic Head Holder and Regulatory Importance

A Radiographic Head Holder is a specialized medical device designed to securely position a patient's head during radiographic procedures, ensuring precision and safety in imaging. Classified under Interventional Radiology, this device falls within Class A—the lowest risk classification in India’s medical device regulatory framework. Despite its low-risk status, obtaining the correct CDSCO license is crucial for manufacturers and importers aiming to legally market this device in India. Compliance not only guarantees regulatory acceptance but also fosters trust among healthcare providers and patients.

With over 25 years of experience helping more than 500 companies navigate CDSCO licensing, we provide an expert roadmap tailored specifically for Radiographic Head Holder manufacturers and importers.

CDSCO Regulatory Framework for Radiographic Head Holder

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules (MDR) 2017. The Radiographic Head Holder is notified under notification number 29/Misc./03/2020-DC (146), dated 26.07.2021, categorizing it as a Class A device.

Class A devices are considered low risk and are regulated by the State Licensing Authority rather than the Central Licensing Authority. This distinction simplifies the licensing process but does not diminish the need for thorough compliance.

Risk Classification and License Requirements

As a Class A device, the Radiographic Head Holder requires a Manufacturing License MD5, obtained by submitting the application on Form MD3. The regulatory process involves:

• Obtaining a Test License (Form MD13) for product testing.
• Product testing at government-approved laboratories.
• Document preparation and submission.
• Audit by a notified body.
• Resolution of any queries raised.
• Final grant of the manufacturing license (Form MD5).

For detailed classification guidance, manufacturers can refer to the Medical Device Classification resource.

Manufacturing License Process (MD5) for Radiographic Head Holder

1. Apply for Test License (Form MD13): The initial step involves securing a test license that permits testing the Radiographic Head Holder. This process typically takes 1.5 to 2 months.

2. Product Testing: Testing must be conducted in CDSCO-approved laboratories. For the Radiographic Head Holder, tests focus on material safety, mechanical stability, and biocompatibility. Refer to the Testing Laboratories list to select an accredited lab.

3. Document Preparation: Assemble comprehensive documentation including the Device Master File, Plant Master File, Quality Management System (QMS) documents, and risk management files.

4. Application Submission for MD5 License: Submit Form MD3 for the manufacturing license on the CDSCO MD Online Portal.

5. Audit by Notified Body: A notified body from the official list will conduct an audit of the manufacturing facility and documentation.

6. Query Resolution: Address any observations raised by the licensing authority or notified body promptly.

7. Grant of License: Upon successful audit and query resolution, the MD5 license is granted.

For an in-depth walkthrough, consult our MD5 License Guide.

Manufacturing License Documents Required for Radiographic Head Holder

To streamline your application, ensure the following documents are prepared and verified:

• Company Constitution: Legal documents proving company registration.
• Proof of Premises Ownership or Lease: Valid documents confirming the manufacturing site.
• Technical Staff Qualification and Experience: Details of personnel responsible for manufacturing.
• Fire and Pollution NOCs: No Objection Certificates from respective authorities.
• Device Master File (DMF): Detailed specifications and design information (Device Master File Guide).
• Plant Master File (PMF): Manufacturing processes, equipment, and quality control details (Plant Master File Guide).
• Essential Principles Checklist: Compliance with safety and performance requirements.
• Risk Management File: Risk analysis and mitigation strategies (Risk Management Guide).
• Test Reports: Results from government-approved labs.
• Labels and Instructions for Use (IFU): Compliant labeling and user manuals.
• Quality Management System Documents: Evidence of ISO 13485 or equivalent QMS implementation.

Import License Process (MD15) for Radiographic Head Holder

Although primarily focused on manufacturing, importers must secure an MD15 license from the Central Licensing Authority. The process involves:

• Document preparation, including the manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, Device Master File, and Plant Master File.
• Application submission via Form MD14 on the CDSCO MD Online Portal.
• Resolution of queries.
• License grant (Form MD15).

The entire process typically requires 5 to 6 months. For detailed guidance, visit our Import License Guide.

Import License Documents Required

• Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate
• Device Master File
• Plant Master File
• Wholesale License
• Company Constitution

Timeline and Processing Duration

Total Estimated Time: Approximately 3 to 4 months for the MD5 manufacturing license.

Government Fees and Costs

• Application Fee: ₹5,000 per application
• Product Fee: ₹500 per product

Additional costs include testing fees at government-approved labs and audit fees charged by notified bodies. Planning a budget that accommodates these expenses helps avoid delays.

Common Challenges and Solutions

Challenge 1: Delays in Testing Many manufacturers experience delays while waiting for test results due to backlog at testing laboratories.

Solution: Engage with the testing lab early and choose less busy accredited labs from the Testing Laboratories list.

Challenge 2: Incomplete Documentation Incomplete or inaccurate documentation is a frequent cause of application rejection.

Solution: Use comprehensive checklists and templates, such as those found in our Device Master File and Plant Master File guides, to ensure completeness.

Challenge 3: Audit Non-compliance Failing audits due to inadequate QMS or facility non-conformities can prolong licensing.

Solution: Pre-audit your facility and processes with experienced consultants to identify gaps and implement corrective measures.

Expert Consultation and Support

Our team, with 25+ years in regulatory consultancy, offers hands-on support throughout your licensing journey—from test license applications to audit preparation and query resolution. We have successfully guided over 500 companies, including those manufacturing radiographic devices, ensuring smooth and timely approvals.

Getting Started with Your CDSCO License Application for Radiographic Head Holder

1. Verify Device Classification: Confirm your Radiographic Head Holder is Class A.
2. Prepare Documentation: Start compiling the required dossiers using our detailed guides.
3. Apply for Test License: Submit Form MD13 via the CDSCO MD Online Portal.
4. Schedule Testing: Coordinate with an approved testing lab promptly.
5. Engage a Notified Body: Identify and contact a notified body from the official list for your audit.
6. Submit Manufacturing License Application: Apply on Form MD3 after successful testing.
7. Prepare for Audit: Conduct internal audits and staff training to ensure compliance.
8. Respond Timely to Queries: Address any queries from CDSCO or notified bodies without delay.

By following this structured approach and leveraging expert support, manufacturers and importers can efficiently secure their CDSCO MD5 license for the Radiographic Head Holder and confidently enter the Indian market.

For personalized assistance and a detailed roadmap tailored to your business, contact our regulatory experts today.