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CDSCO Manufacturing License for Flexible fibreoptic enteroscope

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Introduction

Central Drugs Standard Control Organization, otherwise known as CDSCO, is an authoritative body in India that holds significant importance in the medical device industry. This national regulatory body oversees the approval of new drugs, clinical trials, and the production of medical devices. Manufacturing licenses for medical devices are a crucial aspect governed by CDSCO, emphasizing the safety and quality standards.

The medical device under our lens is the Flexible fibreoptic enteroscope. This device is a crucial tool in gastroenterology, intended for the visual examination and treatment of the small intestine. It offers insights into the duodenum, jejunum, and ileum. Understand more about the manufacturing of Flexible fibreoptic enteroscope and its licensing on CDSCO's portal (https://cdscomdonline.gov.in/NewMedDev/Homepage).

What is Flexible fibreoptic enteroscope?

This is essentially an endoscope with a flexible inserted portion. Its primary function serves the visual examination and treatment of the small intestine. It mirrors the significance of a vehicle delivering a window into the often explored regions of the duodenum, jejunum, and ileum. The common uses and procedures involving a Flexible fibreoptic enteroscope include diagnosis and treatment procedures related to the small intestine. These might involve diagnosis of gastrointestinal bleeding, neoplasia, chronic abdominal pain, and other small bowel diseases.

The Role of CDSCO in Medical Device Regulation

CDSCO, through years of operation, contributes significantly to public health in India. It carries forward the mission of safeguarding and enhancing public health by ensuring the quality, safety, and efficacy of drugs, cosmetics, and medical devices. The organization provides a robust regulatory framework for medical devices, which encompasses established norms for manufacturing, import, and clinical trials.

It categorizes medical devices based on risk associated under Class A (low risk), Class B (low moderate risk), Class C (moderate high risk), and Class D (high risk). For manufacturing a Class B medical device like the Flexible fibreoptic enteroscope, a manufacturer requires MD5 license.

How to Manufacture Flexible fibreoptic enteroscope

Fees for Manufacturing License for Flexible fibreoptic enteroscope

The manufacturing license fee for a medical device under Class B, like the Flexible fibreoptic enteroscope, is categorized primarily under the MD5 type. The fee for MD5 is Rs. 5,000 for the license and Rs. 500 per product.

Why is a Manufacturing License Necessary for Flexible fibreoptic enteroscope?

Securing a manufacturing license is mandatory for producing Flexible fibreoptic enteroscope. This license ensures the production of quality and regulatory-compliant medical devices while protecting patients and consumers from substandard products.

Steps to Obtain a CDSCO Manufacturing License for Flexible fibreoptic enteroscope

Acquiring a CDSCO manufacturing license for a Class B medical device like Flexible fibreoptic enteroscope involves submission of required documentation like Device Master File, Quality Management Certificate, Device Details, Site details etc. The application process involves submission to approval and can be accompanied by various challenges that can be overcome with the right knowledge and guidance.

Frequently Asked Questions (FAQs)

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

  • Flexible fibreoptic enteroscope falls under Class B as per Medical Device Rules, 2017.

Q2. What license in needed to manufacture Flexible fibreoptic enteroscope?

  • MD5 license is required to manufacture Flexible fibreoptic enteroscope.

Q3. What is the fee for MD5 license for Flexible fibreoptic enteroscope?

  • The fee is Rs. 5,000 for the MD5 license and Rs. 500 per product.

Q4. Who will issue the manufacturing license for Flexible fibreoptic enteroscope?

  • For Class B devices, the state FDA will issue the license.

Q5. Is repackaging of Flexible fibreoptic enteroscope considered manufacturing?

  • Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. Since medical devices also fall under the definition of drugs, hence repackaging of Flexible fibreoptic enteroscope would require a license.

Conclusion

Understanding the CDSCO licensing process can be comprehensive and obtaining a manufacturing license can be challenging. For further assistance regarding the licensing process reach out to Pharmadocx Consultants. Visit the website "https://www.pharmadocx.com", or call at "+91-7404557227", or drop an email at "[email protected]". For deeper insights into acquiring an MD5 license, click here: https://pharmadocx.com/md-5-licesne-class-a-b-medical-devices

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