CDSCO License for Radiation protection goggles

Comprehensive Guide to CDSCO Licensing for Radiation Protection Goggles (Class A)

Radiation protection goggles are essential personal protective equipment (PPE) designed to shield the eyes of healthcare operators and personnel from harmful primary and scattered radiation during medical and dental diagnostic and treatment procedures. Given their critical role in safety, these goggles fall under Class A, the lowest risk category for medical devices in India, but still require strict regulatory compliance. With over 25 years of experience and having supported 500+ companies in obtaining CDSCO licenses, we provide you a detailed pathway to secure your MD5 manufacturing license quickly and efficiently.

CDSCO Regulatory Framework for Radiation Protection Goggles

The Central Drugs Standard Control Organization (CDSCO) regulates all medical devices in India, including PPE like radiation protection goggles. According to the notification File No. 29/Misc./03/2020-DC (186) dated 13.9.2021, these goggles are classified as Class A devices, governed under the Medical Device Rules, 2017. Compliance ensures your product meets safety standards, enabling legal manufacture, sale, and distribution in India.

Risk Classification and License Requirements for Class A PPE

Class A devices, such as radiation protection goggles, are considered low-risk. They require an MD5 license, granted by the State Licensing Authority, to manufacture within India. The MD5 license application process involves multiple steps including obtaining a Test License (MD13), product testing from approved government labs, documentation, and a notified body audit.

For a detailed understanding of device classes and their implications, refer to our Medical Device Classification guide.

Manufacturing License Process (MD5) for Radiation Protection Goggles

The MD5 manufacturing license process typically spans 3 to 4 months and involves:

1. Test License (Form MD13): Obtain a test license to legally manufacture prototypes for testing. This step takes about 1.5 to 2 months.
2. Product Testing: Conduct product performance and safety testing at CDSCO-approved labs. Access the list of Testing Laboratories for your testing needs.
3. Documentation Preparation: Compile comprehensive documentation including Device Master File (DMF), Plant Master File (PMF), risk management, and quality management system documents.
4. Application Submission (Form MD3): Submit the MD5 license application via the CDSCO MD Online Portal.
5. Audit by Notified Body: Undergo a mandatory audit by an authorized notified body. Choose from the list of notified bodies for your audit.
6. Query Resolution: Address any queries raised by CDSCO or the notified body promptly.
7. License Grant (Form MD5): Upon successful audit and clearance, the State Licensing Authority issues the manufacturing license.

For a step-by-step walkthrough, our MD5 License Guide offers valuable insights.

Manufacturing License Documents Required

The following documents are essential for the MD5 license application for radiation protection goggles:

• Company Constitution/Registration Certificate
• Proof of Ownership or Lease of Manufacturing Premises
• Details of Technical Staff and their Qualifications
• Fire Safety NOC and Pollution Control NOC
• Device Master File (DMF) detailing design, specifications, and manufacturing process. Our Device Master File Guide can assist you.
• Plant Master File (PMF) outlining manufacturing facilities and quality controls. Learn how to compile one in our Plant Master File Guide.
• Essential Principles Checklist confirming compliance with safety and performance criteria
• Risk Management File documenting hazard analysis and mitigation strategies
• Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents such as ISO 13485 certification

Ensuring all documents are thorough and accurate substantially reduces delays.

Import License Process (MD15) for Radiation Protection Goggles

If you plan to import radiation protection goggles into India, the MD15 import license issued by the Central Licensing Authority is mandatory. The process takes approximately 5 to 6 months.

Key steps include:

• Preparing documents such as the manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE certificate, DMF, PMF, and Wholesale License.
• Applying on the CDSCO MD Online Portal using Form MD14.
• Responding to queries and providing clarifications.
• Receiving the import license (Form MD15).

Refer to our Import License Guide for detailed procedures and tips.

Import License Documents Required

• Valid Manufacturing License from Country of Origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate or Equivalent
• Device Master File
• Plant Master File
• Wholesale License
• Company Constitution and Authorization Letter

Timeline and Processing Duration

Plan your project timelines accordingly, considering possible audit and query resolution times.

Government Fees and Costs

• MD5 License: Rs. 5,000 per application + Rs. 500 per product
• MD13 Test License: Fees vary by state; typically included within MD5 process

These fees are minimal compared to the benefits of legal market access.

Common Challenges and Solutions

• Incomplete Documentation: Missing or inconsistent files cause delays. Solution: Use comprehensive checklists like our DMF and PMF guides.
• Delayed Testing: Lab backlogs can stall progress. Solution: Schedule testing early and select labs with shorter turnaround.
• Audit Non-Compliance: Facilities not meeting QMS or Good Manufacturing Practices (GMP) standards lead to repeated audits. Solution: Perform internal audits and pre-audit readiness checks.
• Query Management: Delayed responses to CDSCO queries extend timelines. Solution: Assign dedicated regulatory personnel to manage communications.

Expert Consultation and Support

With over two decades of experience, our regulatory consultancy has successfully navigated the CDSCO licensing landscape for over 500 manufacturers and importers. We offer tailored support including:

• Gap analysis and readiness assessment
• Document preparation and review
• Liaison with notified bodies and CDSCO
• Training on regulatory compliance and quality systems

Partnering with experts can save months of effort and optimize your market entry.

Getting Started with Your CDSCO License Application for Radiation Protection Goggles

1. Assess your device classification and regulatory pathway. Confirm Class A status and prepare for the MD5 license.
2. Initiate the Test License (MD13) application on the CDSCO MD Online Portal.
3. Engage a CDSCO-approved testing laboratory early for product evaluation.
4. Prepare robust documentation including Device Master File and Plant Master File using our detailed guides.
5. Schedule your notified body audit and ensure your manufacturing premises comply with all norms.
6. Submit the MD5 license application (Form MD3) through the CDSCO portal.
7. Respond swiftly to any queries and maintain open communication with regulatory authorities.

Starting early and following a structured approach significantly enhances your chances of smooth approval. Contact us to discuss your specific project needs and gain access to our proven regulatory strategies.

For more in-depth guidance, explore our MD5 License Guide and related resources.