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CDSCO Manufacturing License for Intravascular administration set, automated air removal system.

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is India's primary pharmaceutical regulatory body. Charged with protecting public health by ensuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices, CDSCO's functions and responsibilities are wide-ranging and critical to the nation's healthcare sector.

One such critical role CDSCO plays in the medical device industry is the issuance of manufacturing licenses. These licenses ensure that medical devices such as the Intravascular Administration Set are produced according to stringent quality and safety standards. Only then can patients and healthcare professionals use them, confident in their efficacy.

The Intravascular Administration Set, an automated air removal system, is an invaluable tool in a variety of medical applications, lending to its medical significance in today's healthcare industry.

For more information, visit CDSCO's portal here

What is Intravascular Administration Set, Automated Air Removal System?

An Intravascular Administration Set is a medical device intended to detect and automatically remove air from an intravascular administration set with minimal to no interruption in the flow of the intravascular fluid. It is primarily utilized in healthcare facilities such as General Hospitals or Orthopaedic wards. The ability to remove air bubbles from an intravascular line ensures the safety of patients undergoing any treatment that requires the use of such a line.

The Role of CDSCO in Medical Device Regulation

The Central Drugs Standard Control Organization (CDSCO) has upheld the vision of protecting public health in India since its inception. Regulations for medical devices fall under the aegis of the CDSCO's responsibilities to ensure safety, efficacy, and quality in medical device production and use.

How to manufacture Intravascular Administration Set?

The manufacturing of Intravascular Administration Set involves production processes and quality control measures that adhere to CDSCO regulations. Given that this is a Class B medical device, the appropriate manufacturing license required is MD5. It ensures adherence to the specific standards set out by the CDSCO for this category of medical devices.

Fees for manufacturing license for Intravascular Administration Set

The fees for obtaining an MD5 license, which is required for manufacturing Intravascular Administration Sets, is Rs. 5,000 for the license and an additional Rs. 500 per product.

Why is a Manufacturing License Necessary for Intravascular Administration Set?

Obtaining a manufacturing license for medical devices such as the Intravascular Administration Set is mandatory by law. It ensures the quality and safety of medical device production. The license signifies regulatory compliance critical to the credibility of the healthcare sector and the protection of patients from substandard products.

Steps to Obtain a CDSCO Manufacturing License for Intravascular Administration Set

To obtain a CDSCO manufacturing license, there are necessary prerequisites and documentation requirements, such as a Device Master File, Quality Management Certificate, Device Details, Site details, etc. The process involves submission, review, and eventual approval of the application. There could be challenges in the process, but they can be overcome with diligent adherence to prescribed guidelines. For more details on how to obtain an MD5 license, you can visit this article

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Intravascular Administration Set, Automated Air Removal System as per Medical Device Rules, 2017?

A. The risk class of Intravascular Administration Set, Automated Air Removal System is Class B.

Q2. What license is needed to manufacture Intravascular Administration Set, Automated Air Removal System?

A. To manufacture Intravascular Administration Set, Automated Air Removal System, you need an MD5 license.

Q3. What is fees for MD5 license for Intravascular Administration Set, Automated Air Removal System?

A. The fees for MD5 license is Rs. 5,000 for the license and Rs. 500 per product.

Q4. Who will issue the manufacturing license for Intravascular Administration Set, Automated Air Removal System?

A. For Class B devices like Intravascular Administration Set, Automated Air Removal System, the state FDA will issue the license.

Q5. Is repackaging of Intravascular Administration Set, Automated Air Removal System, considered manufacturing?

A. 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 Intravascular Administration Set, Automated Air Removal System, is also considered manufacturing requiring a license on MD5.

Conclusion

The process of obtaining a CDSCO Medical Device License can be a complex one, but with the right guidance, it becomes much easier. If you need assistance navigating the regulatory landscape of medical device licensing in India, get in touch with us at Pharmadocx Consultants. Our team of seasoned professionals can guide you through every step of the process. Visit us at Pharmadocx, give us a call at "+91-7404557227", or email us at "[email protected]".

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