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CDSCO Manufacturing License for Flexible video colonoscope, single-use

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Introduction

The Central Drugs Standard Control Organization (CDSCO) plays an integral role in the healthcare sector, acting as the national regulatory authority and watchdog for quality control of drugs, diagnostics, and medical devices in India. One of its pivotal roles includes issuing manufacturing licenses for medical devices, ensuring patient safety and upholding healthcare standards.

One such medical device that requires a CDSCO manufacturing license is the Flexible Video Colonoscope, a pivotal tool in gastroenterology. This article aims to provide a comprehensive guide on acquiring a CDSCO manufacturing license, focusing on this particular device. For more information on medical devices regulations, visit the CDSCO's online portal.

What is Flexible Video Colonoscope?

A flexible video colonoscope is a specialized medical device designed to inspect the entirety of the lower gastrointestinal tract. This device enables healthcare professionals to diagnose or treat conditions such as polyps, tumors, ulcers, or bleeding. Healthcare practitioners primarily use this in procedures such as colonoscopy to screen for early-stage colorectal cancer, among other gastrointestinal diseases.

The Role of CDSCO in Medical Device Regulation

Founded over 72 years ago, the CDSCO plays a vital role in safeguarding public health in India. It is responsible for regulating drugs, cosmetics, and medical devices, ensuring their safety, efficacy, and quality. The regulatory framework set by the CDSCO ensures that all medical devices produced in the country, including the Flexible Video Colonoscope, adhere to approved standards before they are released to the market.

How to Manufacture a Flexible Video Colonoscope

As a CLASS B medical device, a flexible video colonoscope requires specific sterilization procedures and methodologies. The device requires manufacturing in a controlled environment ensuring its efficacy and reliability. All Class B medical devices necessitate a manufacturing license issued by CDSCO or the respective state FDA, depending on the device's risk classification.

Fees for Manufacturing License for the Flexible Video Colonoscope

The issuance of a manufacturing license for a CLASS B medical device requires the payment of specific fees outlined by the CDSCO. For a Class B device like the Flexible Video Colonoscope, the cost includes an MD5 license fee of INR 5,000 and an additional INR 500 per product. This amounts to INR 5,500 as the total fees to be paid.

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

A manufacturing license is obligatory to guarantee consistent quality and safety for medical devices. It plays a critical role in the medical industry by reassuring both healthcare practitioners and patients about the device's efficacy and reliability. Regulatory compliance is imperative in health care, protecting consumers and patients from substandard or potentially harmful products.

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

  1. Prepare and compile all necessary documents (including the Device Master File, Quality Management Certificate, Device Details, Site details etc.).
  2. Submit the application with the requisite documentation.
  3. Follow up the application until approval.
  4. Overcome any challenges encountered, utilizing resources and seasoned expertise.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Flexible Video Colonoscope as per Medical Device Rules, 2017?

A. The Flexible video colonoscope falls under risk class B, as per Medical Device Rules, 2017.

Q2. What license is needed to manufacture a Flexible Video Colonoscope?

A. To manufacture a Flexible Video Colonoscope, an MD5 license is required.

Q3. What is the fee for an MD5 license for a Flexible Video Colonoscope?

A. The fee for an MD5 license for a Flexible Video Colonoscope is INR 5,500, inclusive of the INR 5,000 for the license and INR 500 per product.

Q4. Who will issue the manufacturing license for Flexible Video Colonoscope?

A. For class B devices like the Flexible Video Colonoscope, the state FDA will issue the license.

Q5. Is repackaging of the Flexible Video Colonoscope considered manufacturing?

A. Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of medical devices is also considered manufacturing and requires a license for MD5.

Conclusion

The process of obtaining a manufacturing license from CDSCO is extensive and complex, necessitating expert guidance. Reach out to the esteemed Pharmadocx Consultants who provide stellar services to navigate this process seamlessly. Directly call "+91-7404557227" or send an email to "[email protected]" for invaluable assistance. To know more about the MD5 license for Class B medical devices, glean insights from this detailed article.

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