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CDSCO Manufacturing License for Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure
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Introduction
The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory authority for pharmaceuticals and medical devices. They implement policies and norms pertaining to the manufacturing, sale, and distribution of drugs and medical devices. It is fundamental for medical device manufacturers to adhere to the protocols laid down by CDSCO for maintaining quality and ensuring maximum safety for the end-users.
The Extracorporeal circuit and its accessories hold immense significance in the medical world catering to patients with acute respiratory or cardiopulmonary failure.
Visit CDSCO's portal for comprehensive details.
- What is an Extracorporeal circuit and its accessories for long-term respiratory/cardiopulmonary failure?
- The Role of CDSCO in Medical Device Regulation
- How to manufacture Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure?
- Fees for manufacturing license for Extracorporeal Circuit and accessories for long-term respiratory/cardiopulmonary failure
- Why is a Manufacturing License Necessary for an Extracorporeal Circuit and accessories for long-term respiratory/cardiopulmonary failure?
- Steps to Obtain a CDSCO Manufacturing License for Extracorporeal Circuit and accessories for long-term respiratory/cardiopulmonary failure
- Frequently Asked Questions (FAQs)
- Conclusion
What is an Extracorporeal circuit and its accessories for long-term respiratory/cardiopulmonary failure?
Extracorporeal circuit and its accessories like pump, oxygenator and heat exchanger, are designed cleverly to support patients for more than six hours suffering acute respiratory or cardiopulmonary failure. This device powerfully takes over the function of the lungs and occasionally the heart, providing the medical practitioners a valuable window for treating the underlying disease or disorder.
The Role of CDSCO in Medical Device Regulation
The CDSCO is dedicated to safeguarding public health by ensuring that the medical devices available to the public are effective and safe. Over the years, the CDSCO has played a crucial role in establishing a regulatory framework for medical devices, which constitutes defining the risk classes for the devices and setting guidelines for their manufacturing process.
How to manufacture Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure?
Given that Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure is a Class C device, a manufacturer must obtain MD9 manufacturing license per the CDSCO regulations. Manufacturing commences with the approval of the design and careful selection of materials.
Fees for manufacturing license for Extracorporeal Circuit and accessories for long-term respiratory/cardiopulmonary failure
The fees for an MD9 license is Rs. 50,000, with an additional Rs. 1,000 per product.
Why is a Manufacturing License Necessary for an Extracorporeal Circuit and accessories for long-term respiratory/cardiopulmonary failure?
A manufacturing license is obligatory to ensure that the medical devices produced adhere to the quality and safety norms set by the CDSCO. This leap towards regulatory compliance in the healthcare sector is essential to safeguard consumers from substandard products.
Steps to Obtain a CDSCO Manufacturing License for Extracorporeal Circuit and accessories for long-term respiratory/cardiopulmonary failure
Firstly, one must prepare a Device Master File, a Quality Management Certificate, and provide device and site details. Following this, the application process can be initiated, including submission, reviewing, auditing, and subsequent approval. You could potentially encounter challenges during the application process but have no fear, support is widely available.
Frequently Asked Questions (FAQs)
Q1. What is the risk class of Extracorporeal circuit and its accessories for long-term respiratory/cardiopulmonary failure as per Medical Device Rules, 2017?
Class C.
Q2. What license is needed to manufacture Extracorporeal circuit and its accessories for long-term respiratory/cardiopulmonary failure?
MD9 License is needed.
Q3. What is the fee for the MD9 license for an Extracorporeal circuit and its accessories for long-term respiratory/cardiopulmonary failure?
The fee for an MD9 license is Rs. 50,000, plus Rs. 1,000 for each product.
Q4. Who will issue the manufacturing license for an Extracorporeal circuit and its accessories for long-term respiratory/cardiopulmonary failure?
For Class C devices like this, the CDSCO HQ in New Delhi will issue the license.
Q5. Is repackaging of an Extracorporeal circuit and its accessories for long-term respiratory/cardiopulmonary failure considered manufacturing?
Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of the medical device is considered manufacturing requiring an MD9 license.
Conclusion
Acquiring a CDSCO Manufacturing License can be a convoluted process. If you require further assistance or consultation, don't hesitate to contact Pharmadocx Consultants or call +91-7404557227 or email to [email protected].
For further reading on obtaining an MD9 license, check-out this article. Don't brave the storm alone; Pharmadocx is here to help ensure the process is smooth.
