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CDSCO Manufacturing License for Intracardiac oximeter

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is a paramount drug regulatory body in India. CDSCO's functions include procuring necessary regulations, approvals, and guidelines that assure the safety, efficacy, and quality of drugs, cosmetics, and medical devices in the country. Given the immensity of India's population and its expanding pharmaceutical and healthcare sectors, the role of CDSCO with its multifaceted responsibilities is extremely significant.

The manufacturing licenses issued by CDSCO ensure quality control and adherence to the regulations specified by the organization. Entities looking to manufacture medical devices require these licenses to ensure safety standards and legal compliance. CDSCO's manufacturing licenses are specific to the category and class of the medical device.

In this blog, we will focus on one specific medical device, the Intracardiac oximeter. The Intracardiac oximeter plays a crucial role in medical procedures requiring the measurement of oxygen concentration within the heart. To know more about the licensing details of this device and the regulations around it, do visit the CDSCO's portal.

What is an Intracardiac Oximeter?

An Intracardiac Oximeter is a photoelectric medical device. It uses a known wavelength of radiation, which is transmitted through the blood. The device then measures the concentration of oxygen or dye within the heart, based on the amount of reflected or scattered radiation. It is commonly used in anesthesia and other medical procedures that require monitoring oxygen levels in the blood.

The Role of CDSCO in Medical Device Regulation

CDSCO's history spans several decades, with its mission encompassing the seamless regulation of drugs and medical devices in India. The organization has rolled out various regulatory frameworks for diverse medical devices, An important focus area being device-specific manufacturing licenses.

How to manufacture an Intracardiac Oximeter

To manufacture an Intracardiac Oximeter in India, entities need to comply with the CDSCO's regulatory requirements and mandates. A manufacturing license, for one, is a legal necessity.

Fees for manufacturing license for an Intracardiac Oximeter

Intracardiac Oximeter is a Class B medical device. Therefore, in order to manufacture this device, the necessary license is MD5. The fee structure for an MD5 license is Rs. 5,000 for the license and Rs. 500 per product.

Why is a Manufacturing License Necessary for an Intracardiac Oximeter?

Obtaining a manufacturing license for an Intracardiac Oximeter is mandatory as it guarantees quality and safety in medical device production. Ensuring regulatory compliance is crucial in the healthcare sector and is pivotal in protecting consumers and patients from substandard products.

Steps to Obtain a CDSCO Manufacturing License for an Intracardiac Oximeter

The process of obtaining a CDSCO Manufacturing License for an Intracardiac Oximeter involves compliance with documentation requirements, including the submission of a Device Master File, Quality Management Certificate, Device Details, Site details, etc. The application process includes stages from submission to approval. Entities often face challenges during this procedure but reliable consultancy support can help overcome these obstacles.

Frequently Asked Questions (FAQs)

  1. Q: What is the risk class of an Intracardiac Oximeter as per Medical Device Rules, 2017? A: The Intracardiac Oximeter falls under Class B as per the Medical Device Rules, 2017.

  2. Q: What license is needed to manufacture an Intracardiac Oximeter? A: An MD5 license is required to manufacture the Intracardiac Oximeter.

  3. Q: What is the fee for an MD5 license for an Intracardiac Oximeter? A: The fee for an MD5 license is Rs. 5,000 for the license and Rs. 500 per product.

  4. Q: Who will issue the manufacturing license for an Intracardiac Oximeter? A: For Class B devices such as the Intracardiac Oximeter, the state FDA will issue the license.

  5. Q: Is repackaging of Intracardiac Oximeter considered manufacturing? A: Yes, as per the 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 the Drug Act only and hence repackaging of an Intracardiac Oximeter is also considered manufacturing requiring an MD5 license.

Conclusion

Understanding the intricacies of CDSCO medical device regulations and obtaining a manufacturing license can be a complex task. It's recommended to seek consultation or assistance regarding the licensing process to ensure seamless and successful compliance. Pharmadocx Consultants offer expert guidance in this regard. Connect with them at their website, call them at +91-7404557227 or email at [email protected].

Useful insights about MD5 license procedures can be explored further on this linked article.

Remain updated, remain informed, and ensure quality and safety compliance in healthcare through the reliable assistance of Pharmadocx Consultants.

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