CDSCO License for Radiation protection apron

Radiation Protection Apron: Essential Regulatory Overview and CDSCO Licensing Importance

Radiation protection aprons are critical personal protective equipment designed to shield patients, operators, and healthcare personnel from harmful radiation during medical and dental procedures. For manufacturers and importers aiming to enter the Indian market, obtaining the correct CDSCO license is mandatory to ensure legal compliance and market access. With over 25 years of regulatory expertise, we have supported 500+ companies in navigating India's complex medical device approval landscape, specifically for Class A devices like radiation protection aprons.

CDSCO Regulatory Framework for Radiation Protection Aprons

In India, medical devices fall under the governance of the Central Drugs Standard Control Organization (CDSCO). Radiation protection aprons, classified as Class A devices due to their low risk, are regulated under the Medical Device Rules (MDR) 2017 notification dated 13.09.2021 (File No. 29/Misc./03/2020-DC (186)). This framework mandates manufacturers to acquire an MD5 manufacturing license from the State Licensing Authority before marketing.

Risk Classification and License Requirements for Class A Devices

Class A devices are considered low-risk and include personal protective equipment such as radiation protection aprons. For these devices, the CDSCO requires:

• Manufacturing License: MD5 License (Application Form MD3), granted by the State Licensing Authority.
• Test License: MD13 License (required before MD5), enabling product testing in government-approved labs.

This tiered licensing ensures the device meets safety and quality standards through rigorous testing and audits.

Manufacturing License Process for Radiation Protection Aprons (MD5 License)

The MD5 license process typically spans 3 to 4 months from start to finish and involves the following steps:

1. Obtain Test License (MD13): Submit Form MD13 for a test license, valid for 6 months, allowing you to conduct mandatory product tests.
2. Product Testing: Get your radiation aprons tested at a government-approved lab. You can find the list of approved testing laboratories on the CDSCO portal.
3. Document Preparation: Compile comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documents.
4. Application Submission: Apply for the MD5 license using Form MD3 through the CDSCO MD Online Portal.
5. Audit: A notified body conducts an audit of your manufacturing facility. Refer to the list of notified bodies for suitable auditors.
6. Resolution of Queries: Address any queries or deficiencies raised by the notified body or CDSCO.
7. Grant of License: Upon successful audit and document review, the MD5 license is granted.

Manufacturing License Documents Required for Radiation Protection Apron

To ensure a smooth approval process, prepare the following documents meticulously:

• Company Constitution or Incorporation Certificate
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire NOC and Pollution Control NOC
• Device Master File (DMF) detailing product specifications and safety data (see our Device Master File guide)
• Plant Master File (PMF) describing manufacturing processes and infrastructure (Plant Master File guide)
• Essential Principles Checklist confirming compliance with Indian MDR
• Risk Management File outlining hazard analysis and mitigation strategies (Risk Management overview)
• Test Reports from approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documents, preferably ISO 13485:2016 certified

Import License Process for Radiation Protection Aprons (MD15 License)

For importers of radiation protection aprons, an MD15 import license is mandatory. The process is centrally administered and usually takes 5 to 6 months. It involves:

• Preparation of required documents, including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certificate, and CE marking (if applicable).
• Submission of Form MD14 via the CDSCO MD Online Portal.
• Resolution of CDSCO queries.
• Issuance of MD15 import license.

Note that an MD13 test license is not required for import applications.

Import License Documents Required

The import license application demands thorough documentation such as:

• Valid Manufacturing License from the foreign manufacturer
• Free Sale Certificate indicating the product’s market approval abroad
• ISO 13485:2016 and CE Certificates
• Device Master File and Plant Master File
• Wholesale Drug License (if applicable)
• Company constitution and address proof

Timeline and Processing Duration

Timely submission of complete documents and prompt response to queries can significantly reduce delays.

Government Fees and Costs

For Radiation Protection Aprons (Class A), the fees are structured as follows:

• MD5 License: Rs 5,000 per application + Rs 500 per product
• MD13 Test License: Separate fee as per CDSCO guidelines

Import license fees vary by device class and number of products imported. For Class A devices, expect fees around $1000 per site plus$50 per product.

Common Challenges and Solutions

• Incomplete Documentation: Inadequate or inconsistent documents cause delays. We recommend early preparation with checklists and expert reviews.
• Testing Delays: Limited capacity at government-approved labs can extend timelines. Planning testing slots well in advance is critical.
• Audit Non-compliance: Facilities not meeting notified body standards often face rejection. Conduct internal audits to pre-empt issues.
• Query Resolution Delays: Slow responses to CDSCO queries prolong approvals. Designate a dedicated regulatory liaison for swift communication.

Expert Consultation and Support

With over two decades of experience and a track record of 500+ successful CDSCO licenses, we provide end-to-end support—from document preparation to audit assistance. Our experts help you navigate the nuances specific to radiation protection aprons, ensuring compliance with the latest MDR updates.

Getting Started with Your CDSCO License Application for Radiation Protection Aprons

1. Evaluate Your Product Classification: Confirm your device as Class A under the MDR using resources like our Medical Device Classification guide.
2. Prepare Documentation: Initiate the compilation of DMF, PMF, test reports, and QMS documents.
3. Apply for Test License (MD13): Submit your application via the CDSCO MD Online Portal to commence the testing phase.
4. Schedule Product Testing: Book slots at government-approved labs early to avoid bottlenecks.
5. Plan Facility Audit: Engage a notified body from the official CDSCO list to schedule your audit.
6. Submit MD5 License Application: Once testing and audit are complete, file Form MD3 online.
7. Respond Promptly to Queries: Assign a dedicated team member for fast resolution.

By following this structured approach and leveraging expert guidance, manufacturers and importers of radiation protection aprons can secure their CDSCO licenses efficiently and confidently enter the burgeoning Indian medical device market.