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CDSCO Manufacturing License for Suction antichoke device
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Introduction
The Central Drugs Standard Control Organization (CDSCO) is a leading authority in India to regulate the medical and pharmaceutical industry. Its primary responsibility is to provide approval for medical devices, clinical trials, new drugs and cosmetics. Being under the Ministry of Health and Family Welfare, CDSCO is committed to ensuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices available in India.
Manufacturing licenses play a pivotal role in the medical device industry. They are essentially a green flag, permitting the manufacturing units to produce specific medical devices while following the guidelines. In this blog post, we discuss the Suction Antichoke Device, a critical medical device that plays a crucial role in emergencies involving patient airways.
You can learn more about the medical device licenses on CDSCO's portal.
- What is Suction Antichoke Device?
- The Role of CDSCO in Medical Device Regulation
- How to manufacture Suction Antichoke Device
- Fees for manufacturing license for Suction Antichoke Device
- Why is a Manufacturing License Necessary for a Suction Antichoke Device?
- Steps to Obtain a CDSCO Manufacturing License for a Suction Antichoke Device
- Frequently Asked Questions (FAQs)
- Conclusion
What is Suction Antichoke Device?
A Suction Antichoke Device is a life-saving device intended for urgent usage in cases where a foreign object obstructs a patient's airway, leading to potential asphyxiation. By applying suction, the device works by removing the obstructing element, facilitating normal breathing and potentially saving the patient's life. Its common uses include emergency care, accident scenes, and possibly in some cases of medical procedures.
The Role of CDSCO in Medical Device Regulation
The CDSCO, over the years, has established a comprehensive regulatory framework for medical devices that manufacturers need to navigate. Its mission remains the assurance of safety, efficacy, and quality of the wide range of medical devices being used across India. For medical devices like the Suction Antichoke Device, CDSCO plays a crucial role in monitoring, approval, and regulation through licenses like MD5 and MD9, handed out based on device classification.
How to manufacture Suction Antichoke Device
The manufacturing of any medical device involves sophisticated processes to ensure safety, efficacy, and compliance with regulatory standards. For the Suction Antichoke Device, high-quality medical-grade materials and precision-engineered machinery are required in a sterile environment.
Fees for manufacturing license for Suction Antichoke Device
For a Class C device such as the Suction Antichoke Device, the required license is MD9. The fees for applying for an MD9 license amount to Rs. 50,000, and an additional Rs. 1,000 is required per product. You can read more about the MD9 license in this article.
Why is a Manufacturing License Necessary for a Suction Antichoke Device?
It is mandatory to acquire a manufacturing license for producing any medical device, be it low risk or high risk. The licensing process ensures quality in the production of medical devices and emphasizes safety guidelines during manufacturing. Adherence to regulations ensures that substandard products are prevented from entering the market, ultimately protecting patients and consumers. It also maintains market integrity and trust among the consumers.
Steps to Obtain a CDSCO Manufacturing License for a Suction Antichoke Device
- Documentation: Important documents required include the Device Master File, Quality Management Certificate, Device Details, Site details, etc.
- Application: The application process starts with the submission of a duly filled and verified application form along with the necessary documents.
- Evaluation: Once submitted, the application and documents undergo thorough evaluation before approval.
- Approval: After successful verification and evaluation, the manufacturing license is issued.
Frequently Asked Questions (FAQs)
Q1. What is the risk class of Suction Antichoke Device as per Medical Device Rules, 2017?
The Suction Antichoke Device is classified as Class C.
Q2. What license is needed to manufacture Suction Antichoke Device?
The required license for manufacturing the Suction Antichoke Device is MD9.
Q3. What is the fee for the MD9 license for Suction Antichoke Device?
The fee for an MD9 license for the Suction Antichoke Device is Rs. 50,000 for the license and Rs. 1,000 per product.
Q4. Who will issue the manufacturing license for the Suction Antichoke Device?
For a Suction Antichoke Device (Class C), the CDSCO HQ in New Delhi will issue the license.
Q5. Is repackaging of Suction Antichoke Device considered manufacturing?
Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging is considered manufacturing. Hence, repackaging of Suction Antichoke Device also requires obtaining a license, specifically an MD9 license.
Conclusion
The manufacturing of medical devices is a critical part of healthcare. Ensuring the quality and safety of these devices is paramount. Obtaining a manufacturing license from the CDSCO can be a stringent process but rest assured, help is available.
Navigating the path to securing a manufacturing license can be challenging. That's where guided consultation is beneficial. Reach out to the experienced professionals at Pharmadocx Consultants for assistance. They can guide you through the process and ensure you have all the right documents in place. Feel free to call them at +91-7404557227 or send an email to [email protected] for queries or assistance on the entire process.