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CDSCO Manufacturing License for Flexible video colonoscope, reusable

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Introduction

Central Drugs Standard Control Organization (CDSCO) serves as the national regulatory authority for medical devices and pharmaceuticals in India. It ensures the quality, safety, and efficiency of the medical devices manufactured in the country. In the medical device industry, manufacturing licenses play a crucial role, assuring that the devices are validated to meet the set standards.

The medical device we're focusing on today is a Flexible Video Colonoscope, a critical instrument in the field of gastroenterology. It is designed for the visual examination and treatment of the entire colon, and falls under the risk class B. For information on regulatory compliance and licensing procedures, please refer to CDSCO's portal.

What is a Flexible Video Colonoscope?

A flexible video colonoscope refers to an endoscope with a flexible inserted portion intended for visual examination and treatment of the colon. This cutting-edge instrument is employed commonly for procedures, such as colonoscopy, which facilitates the screening, diagnosis, and treatment of colorectal conditions.

The Role of CDSCO in Medical Device Regulation

Established under the Drugs and Cosmetics Act, CDSCO's main purpose is to maintain the standard of drugs and medical devices in India. The body lays down the regulatory framework for medical devices, which is essential in ensuring the devices' safety and efficacy.

How to manufacture a Flexible Video Colonoscope

The manufacturing process of a flexible video colonoscope calls for stringent quality controls and alignment with CDSCO's rules and regulations. Ensuring that the device meets the standards outlined under the Medical Device Rules, 2017 is an integral part of the process.

Fees for manufacturing license for a Flexible Video Colonoscope

Given that a flexible video colonoscope falls under risk class B, the required license to manufacture it is MD5. The fees for MD5 is Rs. 5,000 for the license and Rs. 500 per product. For more details, please check this article - MD5 License

Why is a Manufacturing License Necessary for a Flexible Video Colonoscope?

The mandatory nature of obtaining a manufacturing license affirms that the medical devices manufactured align with the prescribed safety and quality standards. It enhances regulatory compliance in the healthcare sector, ensuring a benchmark for all medical devices. This implementation of high standard regulation aims to protect consumers from substandard products and efforts, thereby boosting the safety and effectiveness of medical treatments provided to patients.

Steps to Obtain a CDSCO Manufacturing License for a Flexible Video Colonoscope

To get this license, certain documents are required. The need for a Device Master File, Quality Management Certificate, device details, site details, etc., is essential. Applicants must follow the application process from submission to approval, actively addressing any challenges that come their way.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of a Flexible Video Colonoscope as per Medical Device Rules, 2017? The Flexible Video Colonoscope falls under risk class B.

Q2. What license is needed to manufacture a Flexible Video Colonoscope? The license required for manufacturing a Flexible Video Colonoscope is MD5.

Q3. What is the fee for an MD5 license for a Flexible Video Colonoscope? The fee for an MD5 license for the Flexible Video Colonoscope is Rs. 5,000 for the license and Rs. 500 per product.

Q4. Who will issue the manufacturing license for a Flexible Video Colonoscope?? For Class B devices like the Flexible Video Colonoscope, the State FDA will issue the license.

Q5. Is repackaging of a Flexible Video Colonoscope considered manufacturing? Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. By extension, medical devices are also treated as drugs and hence repackaging of the Flexible Video Colonoscope also mandates a license for MD5.

Conclusion

If you're looking for consultation or assistance in the licensing process for the Flexible Video Colonoscope or any other medical device, reach out to Pharmadocx Consultants. You can also call them at +91-7404557227 or email at [email protected]. They are equipped with the expertise and resources to guide you through the manufacturing license application process.

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