CDSCO License for Radiologic quality assurance  instrument

Introduction to Radiologic Quality Assurance Instruments and Their Regulatory Importance

Radiologic quality assurance instruments play a crucial role in ensuring the safety and effectiveness of radiologic devices by measuring their physical characteristics accurately. As these devices fall under the medical device category of Interventional Radiology and are classified as Class A (low risk) under CDSCO guidelines, obtaining the appropriate license is essential for manufacturers and importers aiming to enter the Indian market. With over 25 years of experience and having supported more than 500 companies, we understand the nuances and critical regulatory requirements for seamless CDSCO licensing.

CDSCO Regulatory Framework for Radiologic Quality Assurance Instruments

The Central Drugs Standard Control Organization (CDSCO) governs the import, manufacturing, and sale of medical devices in India. Radiologic quality assurance instruments are regulated under the Medical Device Rules, 2017, which established a risk-based classification system and defined licensing procedures. The device in question is notified under Notification 29/Misc./03/2020-DC (146) dated 26.07.2021, which confirms its regulatory status and requirements.

Risk Classification and License Requirements for Class A Devices

This device is classified as Class A, indicating low risk. According to CDSCO, Class A devices require an MD5 manufacturing license granted by the State Licensing Authority. The licensing process involves obtaining a test license (Form MD13), product testing at government-approved laboratories, documentation preparation, audit by a notified body, and final license issuance. Importers will require an MD15 import license from the Central Licensing Authority.

Manufacturing License Process (MD5) for Radiologic Quality Assurance Instruments

The MD5 license process spans approximately 3-4 months and includes the following steps:

1. Apply for Test License (Form MD13): This initial step takes about 1.5-2 months. The test license allows you to conduct product testing.
2. Product Testing: Conducted at government-approved laboratories listed on the CDSCO Testing Laboratories portal.
3. Documentation Preparation: Compile all required documents including Device Master File, Plant Master File, and Risk Management File.
4. Application Submission (Form MD3): Submit the manufacturing license application through the CDSCO MD Online Portal.
5. Audit by Notified Body: An audit of your manufacturing facility by a notified body listed on the Notified Bodies List is mandatory.
6. Queries Resolution: Address any queries raised by the CDSCO or notified body promptly.
7. Grant of Manufacturing License (Form MD5): Upon successful completion, the license is granted.

Manufacturing License Documents Required for Class A Devices

For radiologic quality assurance instruments, the following documents are essential:

• Company Constitution (e.g., Incorporation Certificate)
• Proof of Ownership or Lease Agreement for manufacturing premises
• Qualification and Experience Certificates of Technical Staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (for design and specifications) — see our detailed Device Master File Guide
• Plant Master File (manufacturing processes) — refer to our Plant Master File Guide
• Essential Principles Checklist
• Risk Management File tailored for radiologic devices (Risk Management Guide)
• Test Reports from approved labs
• Labels and Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485 compliant preferred)

Import License Process (MD15) for Radiologic Quality Assurance Instruments

For importers, the MD15 license is mandatory and is granted by the Central Licensing Authority. The process generally takes 5-6 months and involves:

1. Documentation Preparation: Includes the manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate if applicable, Device and Plant Master Files, and Wholesale License.
2. Application Submission (Form MD14): Submit through the CDSCO MD Online Portal.
3. Queries Resolution: Promptly respond to any CDSCO queries.
4. Grant of Import License (Form MD15): License is issued following successful review.

Import License Documents Required

• Valid Manufacturing License from country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License
• Company Constitution and Address Proof

Timeline and Processing Duration

Starting early preparation of documentation can significantly streamline these timelines.

Government Fees and Costs

For Class A devices such as radiologic quality assurance instruments, the fees are:

• MD5 License: Rs 5,000 per application + Rs 500 per product
• MD13 Test License: Fees as per state authority (varies)
• MD15 Import License: $1,000 per site +$50 per product

Note that audit costs by notified bodies are separate and vary depending on the body and scope.

Common Challenges and Solutions

Challenge: Delays in product testing due to laboratory backlogs.

Solution: Engage with government-approved labs early and consider multiple labs to expedite testing.

Challenge: Preparing comprehensive Device and Plant Master Files that meet CDSCO standards.

Solution: Utilize expert guidance and our detailed Device Master File Guide and Plant Master File Guide.

Challenge: Audit non-compliance issues during notified body inspection.

Solution: Conduct internal mock audits and ensure a robust Quality Management System (QMS) is in place before the official audit.

Expert Consultation and Support

With over 25 years of experience and having supported 500+ companies, we provide end-to-end assistance for CDSCO licensing of radiologic quality assurance instruments. Our services include documentation preparation, audit readiness, test license application, and prompt resolution of regulatory queries.

Getting Started with Your CDSCO License Application

1. Assess your device classification: Confirm your device as Class A under CDSCO regulations.
2. Prepare your technical documentation: Begin compiling your Device Master File, Plant Master File, Risk Management File, and QMS documents.
3. Apply for Test License: Submit your MD13 application via the CDSCO MD Online Portal to initiate product testing.
4. Select testing laboratory: Choose from CDSCO’s list of approved Testing Laboratories.
5. Schedule notified body audit: Identify and book audit dates with a notified body from the Notified Bodies List.
6. Submit manufacturing license application (MD3): After successful testing, apply for the MD5 license.
7. Prepare for audit and queries: Ensure your manufacturing site and documentation are audit-ready.

By following these practical steps and leveraging our expert support, manufacturers and importers can efficiently navigate the CDSCO licensing process and bring their radiologic quality assurance instruments to the Indian market.

For more detailed guidance, feel free to explore our comprehensive MD5 License Guide and reach out for personalized consultation.