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CDSCO Manufacturing License for Cardiopulmonary bypass temperature controller
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- CDSCO Licenses Blog
Introduction
The Central Drugs Standard Control Organization (CDSCO) plays a crucial role in the Indian healthcare sector. Tasked with ensuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices in India, CDSCO is responsible for enforcing the standards laid out in the Drugs and Cosmetics Act 1940, the Drugs and Cosmetics Rules 1945, and other associated regulations. One critical aspect of CDSCO's mandate involves licensing the manufacture of medical devices. This article focuses on CDSCO's manufacturing license for Cardiopulmonary Bypass Temperature Controller, a class B risk device.
Manufacturing licenses assure that quality and safety guidelines are adhered to in the medical device industry. An essential device for cardiovascular procedures, the Cardiopulmonary Bypass Temperature Controller, has significant implications in patient care. Here's a link to CDSCO's portal CDSCO's portal
What is Cardiopulmonary Bypass Temperature Controller?
A cardiopulmonary bypass temperature controller is a medical device designed to control the temperature of the fluid entering and leaving a heat exchanger during cardiovascular procedures. It plays a fundamental role in stabilizing a patient's body temperature during complex surgical procedures.
The Role of CDSCO in Medical Device Regulation
The mission of CDSCO, since its inception, has been to safeguard and enhance public health by assuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices. Notably, it follows a robust regulatory framework governing medical devices that adhere to global quality standards.
How to manufacture Cardiopulmonary Bypass Temperature Controller
The manufacturing of this device follows a systematic and detail-oriented approach ensuring the quality and safety of the product.
Fees for manufacturing license for Cardiopulmonary Bypass Temperature
The fees for obtaining a Class B manufacturing license, also known as MD5, is Rs. 5,000 for the license and Rs. 500 per product.
Why is a Manufacturing License Necessary for Cardiopulmonary Bypass Temperature Controller?
Operational license is mandatory for manufacturing Cardiopulmonary Bypass Temperature Controller. This license ensures the quality and safety of production processes, protects patients from substandard devices and fosters compliance within the healthcare sector, thereby protecting consumers from substandard products.
Steps to Obtain a CDSCO Manufacturing License for Cardiopulmonary Bypass Temperature
The necessary steps for getting the license involve a detailed documentation including Device Master File, Quality Management Certificate, Device Details & Site details, and a systematic licensing process comprising the application submission, evaluation, inspection, and approval.
The process is not without its difficulties, but with the right guidance, obstacles can be successfully navigated to secure license approval.
Frequently Asked Questions (FAQs)
Q1. What is risk class of Cardiopulmonary Bypass Temperature Controller as per Medical Device Rules, 2017? The device falls under class B risk as per Medical Device Rules, 2017.
Q2. What license in needed to manufacture Cardiopulmonary Bypass Temperature Controller? Manufacturing Cardiopulmonary Bypass Temperature Controller requires MD5 license.
Q3. What is fees for MD5 license for Cardiopulmonary Bypass Temperature? The fees for MD5 license is Rs. 5,000.
Q4. Who will issue manufacturing license for Cardiopulmonary Bypass Temperature Controller? For Class B devices, like Cardiopulmonary Bypass Temperature Controller, the state FDA will issue the license.
Q5. Is repackaging of Cardiopulmonary Bypass Temperature Controller considered manufacturing? Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing and by further definitions, medical devices are also drugs. Medical Device Rules have been made under the provisions of Drug Act only and hence repackaging of Cardiopulmonary Bypass Temperature Controller is also considered manufacturing requiring a license.
For a detailed study on MD5 License, you can refer to this article
Conclusion
Navigating the process of getting a medical device licensed can be complicated and confusing, but it doesn't have to be. At Pharmadocx Consultants, we're here to help guide you through every step of the process. So why not reach out today and find out how we can assist you? You can visit our website, call us at +91-7404557227, or email us at [email protected] to learn more or get started.
