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CDSCO Manufacturing License for Anaesthetic gas absorption/desorption device
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Introduction
The Central Drugs Standard Control Organization (CDSCO) is the apex scientific body responsible for the regulation of medical devices, drugs, and cosmetics in India. With the constantly increasing advent of technology, 'healthcare' has become a multidimensional phrase encompassing a broad spectrum of scientific advancements, where medical devices form an integral part. To ensure the safety and efficacy of these devices, a stringent regulatory system is a necessity. This is where CDSCO comes into play, by distinctively defining the standard norms for manufacturing licenses, regulating the quality, safety, and performance of medical devices used in India.
One such essential device is the Anaesthetic Gas Absorption/Desorption device. A critical tool in the world of anaesthesia, this device aids the process of surgeries by absorbing and desorbing exhaled volatile anaesthetic agents. To learn more about this device and the strict regulations set by CDSCO for its manufacture, visit CDSCO's portal.
- What is Anaesthetic Gas Absorption/Desorption device?
- The Role of CDSCO in Medical Device Regulation
- How to Manufacture Anaesthetic Gas Absorption/Desorption device
- Fees for Manufacturing License for Anaesthetic Gas Absorption/Desorption device
- Why is a Manufacturing License Necessary for Anaesthetic Gas Absorption/Desorption device?
- Steps to Obtain a CDSCO Manufacturing License for Anaesthetic Gas Absorption/Desorption device
- Frequently Asked Questions (FAQs)
- Conclusion
What is Anaesthetic Gas Absorption/Desorption device?
The Anaesthetic gas absorption/desorption device is a critical component in the operation theatres. It is integrated within the common line of a breathing circuit and its primary function is to absorb and desorb exhaled volatile anaesthetic agents. This not only aids to effectively make the patient unconscious during an operative procedure without causing discomfort but also promotes anaesthesia management in an eco-friendly manner.
The Role of CDSCO in Medical Device Regulation
The purpose and operation of CDSCO are deep-rooted in ensuring the safety and efficacy of medical devices. The body has been proactive in harmonizing the global standards of medical devices safety, performance, efficacy, and patient accessibility. For this, CDSCO extensively follows a risk-based and scientific approach to frame its regulatory procedures for medical devices.
How to Manufacture Anaesthetic Gas Absorption/Desorption device
Fees for Manufacturing License for Anaesthetic Gas Absorption/Desorption device
The fee for obtaining the manufacturing license for Anaesthetic Gas Absorption/ Desorption device, which falls under 'Class B' risk category, involves a base license fee of Rs. 5,000 and an additional Rs. 500 per product under the MD5 license.
Why is a Manufacturing License Necessary for Anaesthetic Gas Absorption/Desorption device?
A manufacturing license is not just a legal compliance but a mandate to ensure quality and safety. The emphasis on compliance in the healthcare sector ensures the liabilities of medical device manufacturers, protecting patients and consumers from substandard products and ensuring a reduction in the risk of failures and accidents.
Steps to Obtain a CDSCO Manufacturing License for Anaesthetic Gas Absorption/Desorption device
- Preparation of essential documentation including Device Master File, Quality Management Certificate, Device Details, Site Details, etc.
- Submission of a well-prepared application with accurate details.
- Patience during the review and assessment phase.
- Celebration of approval and starting the manufacturing process!
Frequently Asked Questions (FAQs)
Q1: What is the risk class of Anaesthetic Gas Absorption/Desorption device as per Medical Device Rules, 2017? The Anaesthetic Gas Absorption/Desorption device falls under risk class 'B'.
Q2: What license is needed to manufacture Anaesthetic Gas Absorption/Desorption device? The manufacturing of Anaesthetic Gas Absorption/Desorption device, a 'Class B' device, requires an MD5 license.
Q3: What is the fee for MD5 license for Anaesthetic Gas Absorption/Desorption device? The fee structure for the MD5 license involves a base fee of Rs. 5,000 and an additional Rs.500 per product.
Q4: Who will issue the manufacturing license for Anaesthetic Gas Absorption/Desorption device? The state FDA (Food and Drug Administration) will issue the manufacturing license for Class B devices such as the Anaesthetic Gas Absorption/Desorption device.
Q5: Is repackaging of Anaesthetic Gas Absorption/Desorption device 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. Hence repackaging of Anaesthetic Gas Absorption/Desorption device is also considered manufacturing requiring an MD5 license.
Conclusion
The process of obtaining a manufacturing license for medical devices can indeed seem challenging. Though complex, it is essential to ensure that quality and safety protocols are met effectively. For assistance regarding the licensing process, professional guidance, and consultation, feel free to reach out to us at Pharmadocx Consultants. You can also call us directly on +91-7404557227 or drop us an email at [email protected]. Click here to learn more about the MD5 license and the related process.
