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CDSCO Manufacturing License for Ultraviolet (UV) radiation chamber disinfection device.

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for Indian pharmaceuticals and medical devices. As part of its duties, the CDSCO is responsible for the safety, efficacy, and quality of these medical products. Medical devices, such as the Ultraviolet (UV) Radiation Chamber Disinfection Device, are a crucial part of the healthcare industry, and manufacturing these devices requires specific licenses to ensure their quality and safety.

You can find more information about the CDSCO and its regulations on their official website here.

What is an Ultraviolet (UV) Radiation Chamber Disinfection Device?

Ultraviolet (UV) radiation chamber disinfection devices, commonly referred to as UV disinfection devices, are devices that use UV radiation to disinfect a variety of surfaces. These devices are typically designed with a closed chamber where the items to be disinfected are placed. UV light is then used to disinfect the surfaces of those items.

This type of device is most commonly used in hospitals and other medical settings due to its ability to provide effective and efficient disinfection.

The Role of CDSCO in Medical Device Regulation

The CDSCO plays a central role in the regulation of medical devices in India. The organization's mission is to protect and maintain public health by ensuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices. To achieve this mission, the CDSCO employs a rigorous regulatory framework that includes the issuance of manufacturing licenses.

How to Manufacture an Ultraviolet (UV) Radiation Chamber Disinfection Device

Before manufacturing a UV radiation chamber disinfection device, one must obtain a requisite license from CDSCO or state FDA, depending on the risk class of the device. In this case, the UV radiation chamber disinfection device falls under Class C, therefore, the license has to be obtained from the CDSCO headquarters in New Delhi.

Fees for Manufacturing License for the Ultraviolet (UV) Radiation Chamber Disinfection Device

The fee for an MD9 license for a Class C UV radiation chamber disinfection device is Rs. 50,000 for the license, plus an additional Rs. 1,000 per product.

Why is a Manufacturing License Necessary for an Ultraviolet (UV) Radiation Chamber Disinfection Device?

CDSCO mandates the requirement of a manufacturing license for every medical device produced for the purpose of assuring quality, safety, and efficacy. It plays a vital role in protecting consumers and patients from potential health risks associated with substandard devices. In addition, it ensures industry compliance with stringent healthcare regulations.

Steps to Obtain a CDSCO Manufacturing License for an Ultraviolet (UV) Radiation Chamber Disinfection Device

  1. Prepare the necessary documentation, including the Device Master File, Quality Management Certificate, device details, and site details.
  2. Submit these documents to CDSCO.
  3. Await the approval of your application.
  4. If any issues arise during this process, address and resolve them promptly.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of an Ultraviolet (UV) Radiation Chamber Disinfection Device as per Medical Device Rules, 2017?

  • The risk class of a UV radiation chamber disinfection device is Class C.

Q2. What license is needed to manufacture an Ultraviolet (UV) Radiation Chamber Disinfection Device?

  • To manufacture a UV radiation chamber disinfection device, an MD9 license is necessary.

Q3. What is the fee for an MD9 license for an Ultraviolet (UV) Radiation Chamber Disinfection Device?

  • The fee for an MD9 license for a UV radiation chamber disinfection device is Rs. 50,000, plus Rs. 1,000 per product.

Q4. Who will issue the manufacturing license for an Ultraviolet (UV) Radiation Chamber Disinfection Device?

  • The manufacturing license for a UV radiation chamber disinfection device will be issued by the CDSCO headquarters in New Delhi.

Q5. Is repackaging of an Ultraviolet (UV) Radiation Chamber Disinfection Device considered manufacturing?

  • Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing, and by extension, medical devices are also drugs. Consequently, repackaging of a UV radiation chamber disinfection device also requires an MD9 license.

Conclusion

Understanding the process and requirements for obtaining a manufacturing license for medical devices such as the UV radiation chamber disinfection device is vital in the current healthcare space. If you require further assistance in navigating the licensing procedures or have more questions to ensure regulatory compliance, reach out to us at Pharmadocx Consultants. You can also call us at +91-7404557227 or email us at [email protected].

For more specific information regarding the MD9 license for Class C devices (such as the UV radiation chamber disinfection device), you can also refer to this article on our website.

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