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CDSCO Manufacturing License for Colorectal sizer

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Introduction

In the world of medical device manufacturing, a crucial role is played by the Central Drugs Standard Control Organization (CDSCO). Government recognition and administration of the medical device industry are of paramount importance globally. CDSCO is India's central regulatory body that oversees the safety, effectiveness, and quality of drugs, cosmetics, and medical devices. Manufacturing a medical device requires CDSCO certification, ensuring the product's quality matches the globally accepted standards. This article will discuss the manufacturing license details for Colorectal Sizer, an important medical device used in the field of gastroenterology. Visit the official CDSCO portal at CDSCOMDONLINE for more information.

What is a Colorectal Sizer?

A Colorectal sizer is a manual surgical tool designed to assist surgeons in the selection of a properly sized intraluminal stapler for bowel anastomosis following transection. It plays a critical role in colorectal procedures, providing the surgeon with a way to measure the lumen diameter of the colon and/or rectum.

The Role of CDSCO in Medical Device Regulation

Established under the Ministry of Health & Family Welfare, Government of India, CDSCO is the country's main regulatory body for drugs and medical devices. CDSCO's primary function is to ensure that the manufacturing and distribution of medical devices adhere to the required standards of safety and quality. In the case of medical devices like the Colorectal Sizer, the CDSCO provides necessary regulatory oversight to prevent the production and distribution of substandard products.

How to manufacture a Colorectal Sizer

The manufacturing process of a Colorectal Sizer requires compliance with CDSCO regulation and medical device guidelines. Given that the Colorectal Sizer is classified as a Class B medical device, there is a systematic approach for its production. The process entails careful product design, material selection, manufacturing process controls, and stringent quality control measures.

Fees for manufacturing license for Colorectal Sizer

The manufacturing license required for a Colorectal Sizer is MD5, in line with the device's Class B risk classification. The license is priced at Rs. 5,000, with an additional Rs. 500 charged per product.

Why is a Manufacturing License Necessary for Colorectal Sizer?

Obtaining a manufacturing license is essential for maintaining the quality and safety standards in the production of medical devices. Since the Colorectal Sizer is used in sensitive medical procedures, a license from a reputable regulatory body like CDSCO ensures its reliability and effectiveness. It is a signifier of regulatory compliance in the healthcare sector and serves to protect patients and consumers from substandard products.

Steps to Obtain a CDSCO Manufacturing License for Colorectal Sizer

Obtaining a CDSCO manufacturing license involves the submission of several documents such as the Device Master File, Quality Management Certificate, Device Details, Site details among others. The application process includes document submission, assessment by CDSCO, corrections if any, and ultimately, the approval of the manufacturing license. You can learn more from this article about MD-5 license.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Colorectal Sizer as per Medical Device Rules, 2017? A. The risk class of Colorectal Sizer as per Medical Device Rules, 2017 is Class B.

Q2. What license is needed to manufacture Colorectal Sizer? A. The license required to manufacture Colorectal Sizer is MD5.

Q3. What is the fee for MD5 license for Colorectal Sizer? A. The fee for an MD5 license for Colorectal Sizer is Rs. 5,000 for license and Rs. 500 per product.

Q4. Who will issue the manufacturing license for Colorectal Sizer? A. For the Colorectal Sizer, which is a Class B device, the state FDA will issue the license.

Q5. Is repackaging of Colorectal Sizer considered manufacturing? A. Yes, repackaging of medical devices is considered manufacturing according to the Drugs and Cosmetics Act's definition. Hence, repackaging of Colorectal Sizer is also considered manufacturing requiring an MD5 license.

Conclusion

Navigating the licensing process for medical devices can be intricate and time-consuming. If you need consultation or assistance in obtaining a CDSCO manufacturing license for the Colorectal Sizer or any other medical device, feel free to reach out to Pharmadocx Consultants at +91-7404557227 or email us at [email protected].

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