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CDSCO Manufacturing License for Vascular clip

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Introduction

The Central Drugs Standard Control Organization (CDSCO), is India's national regulatory authority committed to ensuring the safety, efficacy and quality of medical devices. Among its responsibilities, it oversees the licensing of medical device manufacturing in the Indian healthcare sector. These licensing regulations play a vital role in ensuring that all medical devices produced meet quality and safety standards, protecting consumers and patients.

One important medical device under the purview of CDSCO is the Vascular clip, a critical device in cardiovascular procedures. You can gather more information about such medical devices and CDSCO's regulative actions at CDSCO's portal.

What is a Vascular Clip?

A Vascular Clip is an implanted extravascular device often put to use in critical cardiovascular procedures. Its primary purpose lies in occluding or blocking the flow of blood by compression, particularly in small blood vessels except the intracranial ones. Vascular Clip's common usage includes a range of procedures, with a broader application within the cardiovascular medical field.

The Role of CDSCO in Medical Device Regulation

The prime mission of CDSCO is to safeguard and improve public health in India. It achieves this grand goal by ensuring the quality of drugs, cosmetics, and medical devices available to the Indian public. A significant part of this goal includes regulating and controlling the manufacture of medical devices in India through a rigorous licensing procedure.

How to Manufacture a Vascular Clip

The manufacturing process of a Vascular Clip involves intricate attention to detail and stringent quality parameters. However, understanding and adhering to CDSCO's regulations and license requirements is the primordial step to embark on the manufacturing of this critical medical device.

Fees for Manufacturing License for a Vascular Clip

Given that a Vascular Clip falls under Risk Class B of the medical devices defined by CDSCO, the necessary license required is MD5. The fee for this license is Rs. 5,000 and an additional sum of Rs. 500 per product.

Why is a Manufacturing License Necessary for a Vascular Clip?

Acquiring a manufacturing license for a Vascular Clip is a mandatory regulatory requirement and goes beyond mere legal obligation. It also plays a pivotal role in assuring the device's quality and safety. Further, a license reflects the manufacturer's commitment to adhere to a high standard of compliance in a vital sector such as healthcare. It helps protect consumers and patients from substandard products, facilitating optimum healthcare outcomes.

Steps to Obtain a CDSCO Manufacturing License for a Vascular Clip

  1. Ensuring the Device Master File, Quality Management Certificate, Device Details, Site details, etc. are prepared and readily available.
  2. Submit these documents along with an application on the CDSCO portal.
  3. The submitted application will undergo a thorough review by regulatory authorities.
  4. On satisfactory fulfilment of all requirements and passing the review, the license is granted.

Obtaining a CDSCO license can be an arduous process. Understanding common challenges and strategies to overcome them would be advantageous.

Frequently Asked Questions (FAQs)

  • Q1: What is the risk class of a Vascular Clip as per Medical Device Rules, 2017?

A: The Vascular Clip is classified as Risk Class B as per Medical Device Rules, 2017.

  • Q2: What license is needed to manufacture a Vascular Clip?

A: To manufacture a Vascular Clip, an MD5 license is required.

  • Q3: What is the fee for an MD5 license for a Vascular Clip?

A: The fee for an MD5 license is Rs. 5,000 for the license and an additional Rs. 500 per product.

  • Q4: Who will issue the manufacturing license for a Vascular Clip?

A: For Class B devices, like a Vascular Clip, the state FDA will issue the license.

  • Q5: Is repackaging of a Vascular Clip considered manufacturing?

A: Yes, repackaging of a Vascular Clip is considered manufacturing, as per the Drugs and Cosmetics Act. As this device falls under class B, repackaging would require an MD5 license.

Conclusion

The process of obtaining a CDSCO manufacturing license for a Vascular Clip may seem intimidating, but rest assured, help is just a click or call away. For consultation or assistance regarding the licensing process, please reach out to our team at Pharmadocx Consultants or call us at +91-7404557227. You can also drop us an email at [email protected].

For more detailed information about obtaining an MD5 license, you can read this article on our website – MD-5 License for Class A & B Medical Devices. We look forward to helping you navigate your way through the medical device licensing process, ensuring compliance and success.

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