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CDSCO Manufacturing License for Intravascular membrane oxygenator

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Introduction

Nestled deep within the Indian healthcare system is the Central Drugs Standard Control Organization (CDSCO), responsible for controlling and regulating vital aspects of the pharmaceutical industry. This includes our focus for this blog article, the medical devices. Manufacturing licenses are the cornerstone of the medical devices industry. They ensure quality, safety, and consistency - a vital triad in healthcare.

One such vital piece in this ever-evolving puzzle of medical innovation is the Intravascular Membrane Oxygenator. It plays a significant role in the management of patients with severe respiratory distress syndrome. For a comprehensive look at CDSCO regulations regarding the Intravascular Membrane Oxygenator, please refer to CDSCO's portal here.

What is an Intravascular Membrane Oxygenator?

An Intravascular Membrane Oxygenator, as the name suggests, is a device intended for intravascular diffusion of oxygen into and carbon dioxide from the blood, using a gas-permeable membrane. It is often employed as a temporary therapeutic intervention for adult patients with severe respiratory distress syndrome.

The Role of CDSCO in Medical Device Regulation

Since its inception, CDSCO has been a primary regulatory body; a steward in the field of drug and medical devices control in India. One of their tasks is to regulate the manufacturing of medical devices such as the Intravascular Membrane Oxygenator to ensure conformity with accepted standards.

How to manufacture an Intravascular Membrane Oxygenator

The manufacturing of an Intravascular Membrane Oxygenator must align with global standards of safety, functionality, and reliability. This process is regulated in part by CDSCO and requires the possession of specific licenses.

Fees for manufacturing license for Intravascular Membrane Oxygenator

Given that the Intravascular Membrane Oxygenator falls under Risk Class C, the required license is MD9. The fee involved is Rs. 50,000 for the license and Rs. 1,000 per Intravascular Membrane Oxygenator product.

Why is a Manufacturing License Necessary for Intravascular Membrane Oxygenator?

Obtaining a CDSCO manufacturing license is not only a legal requirement but also an essential part in ensuring product safety and quality. A license ensures strict adherence to the guidelines laid down for manufacturing, thereby reducing the risk of substandard products reaching the market. Adherence to these standards also propagates a sense of trust and protects consumers from harm.

Steps to Obtain a CDSCO Manufacturing License for Intravascular Membrane Oxygenator

  1. Documentation: A comprehensive list of documents including the Device Master File, Quality Management Certificate, Device Details, and Site Details are required.
  2. Submission: The correctly filled and verified application, along with required documents, must be submitted to the appropriate authority.
  3. Processing: The application, once submitted, will go through various stages of review and scrutiny.
  4. Approval: After establishing the credibility and legitimacy of the application, the manufacturing license will be issued.

For a comprehensive guide to MD9 licensing, check out this article here.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Intravascular Membrane Oxygenator as per Medical Device Rules, 2017?

The Intravascular Membrane Oxygenator comes under Risk Class C.

Q2. What license is needed to manufacture Intravascular Membrane Oxygenator?

The required license for manufacturing Intravascular Membrane Oxygenator is MD9.

Q3. What is the fee for an MD9 license for Intravascular Membrane Oxygenator?

The fee for an MD9 license is Rs. 50,000 and Rs. 1,000 per product.

Q4. Who will issue the manufacturing license for Intravascular Membrane Oxygenator?

CDSCO HQ in New Delhi will issue the license for Class C & D devices, which includes Intravascular Membrane Oxygenator.

Q5. Is repackaging of Intravascular Membrane Oxygenator considered manufacturing?

Yes. Repackaging of Intravascular Membrane Oxygenator is considered manufacturing, requiring a license under MD9.

Conclusion

The CDSCO manufacturing license is a critical step in bringing a medical device to market. This process, although detailed and seemingly daunting, is necessary to ensure the highest level of efficacy and safety. If you require assistance in navigating the ever-changing landscape of CDSCO licensing, consider reaching out to Pharmadocx Consultants. You can find us here or drop a call at +91-7404557227 or email at [email protected].

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