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CDSCO Manufacturing License for Endoscopic cutting stapler connector

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Introduction

The Central Drugs Standard Control Organization (CDSCO) plays a pivotal role in ensuring the safety and efficacy of medical devices in India. As the country's premier regulatory entity for drugs and medical devices, CDSCO emphasizes the importance of manufacturing licenses as a mark of quality, safety, and compliance. The central role of CDSCO in India's healthcare industry cannot be overlooked, especially when it comes to the manufacturing of medical devices like the Endoscopic Cutting Stapler Connector.

The Endoscopic Cutting Stapler Connector, a chief component in gastroenterology procedures, is designed to facilitate a secure connection between the stapler handpiece and the endpiece/loading unit. The significance of this medical device is vast, hence the necessity for its manufacturing to adhere to strict quality and safety measures.

For more information about CDSCO and its various frameworks, visit CDSCO's portal here.

What is Endoscopic Cutting Stapler Connector?

An Endoscopic Cutting Stapler Connector is a rod-like component integral to the function of an endoscopic cutting stapler. It acts as a bridge, enabling a secure connection between the stapler handpiece and the endpiece or loading unit. This connection is crucial in facilitating the smooth operation of stapling during endoscopic procedures.

Common procedures involving the use of an Endoscopic Cutting Stapler Connector often fall within the realm of gastroenterology. Thanks to its intuitive design, it aids in the seamless operation of endoscopic stapling, making it a vital tool in the modern medical toolkit.

The Role of CDSCO in Medical Device Regulation

Over the years, CDSCO has held the mantle of ensuring the highest quality of drugs and medical devices in India. The organization's framework for medical device regulation is comprehensive, covering everything from the manufacturing of medical devices to post-market surveillance.

The core mission of CDSCO is to safeguard public health in India by ensuring that medical devices and drugs, including the Endoscopic Cutting Stapler Connector, stack up to the highest quality of standards and safety measures.

How to manufacture Endoscopic Cutting Stapler Connector

Manufacturing of the Endoscopic Cutting Stapler Connector, a Class B device under the medical devices classification, requires adherence to stringent regulation measures. Manufacturing processes should align with Good Manufacturing Practices (GMP) to ensure the highest levels of safety and efficacy.

Fees for manufacturing license for Endoscopic Cutting Stapler Connector

The CDSCO stipulates a fee structure for acquiring manufacturing licenses for medical devices. As a Class B device, the license required for producing the Endoscopic Cutting Stapler Connector is the MD5. The fees associated with this license include an initial payment of Rs. 5,000 and a subsequent fee of Rs. 500 per product.

Why is a Manufacturing License Necessary for Endoscopic Cutting Stapler Connector?

Obtaining a manufacturing license is a mandatory part of producing the Endoscopic Cutting Stapler Connector. This measure ensures manufacturers adhere to quality and safety standards, offering peak performance of the device. Regulatory compliance in the healthcare sector is integral in protecting consumers and patients from substandard products, ensuring only quality, safe and effective products reach the market.

Steps to Obtain a CDSCO Manufacturing License for Endoscopic Cutting Stapler Connector

Procuring a manufacturing license from CDSCO involves a thorough process, requiring prerequisite documents like Device Master Files, Quality Management Certificate, Device Details, Site details, etc. The process includes;

  1. Submission of application
  2. Documentation review by CDSCO
  3. Facility inspection
  4. Final Approval

Following these steps can involve a few challenges. Engaging an experienced consultancy service like Pharmadocx can facilitate a smoother process.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Endoscopic Cutting Stapler Connector as per Medical Device Rules, 2017?

The Endoscopic Cutting Stapler Connector falls under Class B as per Medical Device Rules, 2017.

Q2. What license is needed to manufacture the Endoscopic Cutting Stapler Connector?

The manufacturing license needed is MD5.

Q3. What is the fee for the MD5 license for the Endoscopic Cutting Stapler Connector?

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

Q4. Who will issue the manufacturing license for the Endoscopic Cutting Stapler Connector?

For Class B devices like the Endoscopic Cutting Stapler Connector, the state FDA will issue the license.

Q5. Is repackaging of the Endoscopic Cutting Stapler Connector considered manufacturing?

Yes, as per the Drugs and Cosmetics Act's definition, repackaging is considered manufacturing and, therefore, requires an MD5 license.

Conclusion

Regulatory compliance is no easy task, and that's why experts like Pharmadocx Consultants are ready to help with comprehensive consultancy services. Need assistance navigating the licensing process? Call us on +91-7404557227, or drop us an email at [email protected]. Further, you might find our guide on MD5 license helpful for obtaining MD5 license for manufacturing class A & B medical devices in India.

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