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CDSCO Manufacturing License for Bulk oxygen concentration system

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is India's central regulatory body for pharmaceuticals and medical devices. As the central competent authority, CDSCO is chiefly responsible for laying down the standards for drugs, cosmetics, diagnostics, and devices in India. It's known for promoting public health by ensuring the quality, safety, and efficacy of the aforementioned products.

In the medical device industry, manufacturing licenses hold great importance. These licenses ensure that devices meet the strict regulations set by CDSCO. They act as proof that the device is safe to use and effective in its intended use. Without such licenses, manufacturing and marketing of medical devices in the medical field are prohibited.

One such device is the Bulk Oxygen Concentration System, an integral part of many healthcare institutions. This device plays a crucial role in providing necessary oxygen support to patients in need. For more information, you can check out CDSCO's portal at here

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What is Bulk oxygen concentration system?

A Bulk Oxygen Concentration System is a system designed to concentrate oxygen from ambient air and then deliver the concentrated O2, with purity of up to 99.5%, to the hospital medical gas supply system. This medical device is commonly used in hospitals, nursing homes, and other medical facilities to provide a steady supply of high-purity oxygen.

The Role of CDSCO in Medical Device Regulation

CDSCO has a significant role to play in medical device regulation in India. It is in charge of providing oversight and regulation for the medical device industry. The goal is to ensure that only safe, effective, and high-quality medical devices can reach the marketplace. CDSCO's regulatory framework for medical devices includes the classification of devices into four categories based on the level of risk - classes A, B, C, and D.

How to manufacture a Bulk oxygen concentration system?

Manufacturing a Bulk Oxygen Concentration System requires comprehensive planning and adherence to industry standards and regulations. Meeting the stringent requirements of CDSCO is a key factor in the manufacturing process.

Fees for manufacturing license for Bulk oxygen concentration system

For Class B devices like a Bulk oxygen concentration system, the appropriate license type is MD5. The fees for obtaining an MD5 license are Rs. 5,000 for the license and Rs. 500 per product.

Why is a Manufacturing License Necessary for Bulk oxygen concentration system?

Acquiring a manufacturing license is mandatory for the Bulk oxygen concentration system. The license acts as a guarantee that the manufacturing processes align with requisite quality standards. Medical devices are pivotal in health care and hence, their quality, safety and efficaciousness are of paramount importance. The license also protects consumers and patients from substandard and ineffective products.

Steps to Obtain a CDSCO Manufacturing License for Bulk oxygen concentration system

Obtaining a CDSCO Manufacturing License for Bulk Oxygen Concentration System involves several steps. These steps include submission of various documents such as Device Master File, Quality Management Certificate, Device Details, and Site details etc., and also involve the completion of the license procedure.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of the Bulk oxygen concentration system as per Medical Device Rules, 2017?

The Bulk oxygen concentration system falls under Class B as per the Medical Device Rules, 2017.

Q2. What license is needed to manufacture Bulk oxygen concentration system?

The MD5 license is needed to manufacture a Bulk oxygen concentration system.

Q3. What is the fee for the MD5 license for the Bulk oxygen concentration system?

The fee for the MD5 license for a Bulk Oxygen System is Rs. 5,000 for the license and Rs. 500 per product.

Q4. Who will issue the manufacturing license for Bulk oxygen concentration system?

For Class B devices like the Bulk Oxygen Concentration System, the State FDA will issue the license.

Q5. Is repackaging of Bulk oxygen concentration system considered manufacturing?

Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. By the same definition, medical devices are also drugs. Medical Device Rules have been made under the provisions of the Drugs Act hence repackaging of the Bulk Oxygen Concentration System is also considered manufacturing requiring a license on MD5.

Conclusion

For readers seeking further consultation or assistance regarding the licensing process, Pharmadocx Consultants is willing to assist. You can reach out at "Pharmadocx Consultants", call at "+91-7404557227" or email your enquiries to "[email protected]".

You can also read more about the MD5 license for class A and class B medical devices at Pharmadocx Consultants

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