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CDSCO Manufacturing License for Ultraviolet (UV) radiation environmental disinfection device

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Introduction

The Central Drugs Standard Control Organization (CDSCO) plays a key role in the safeguarding of public health in India by assuring the quality, safety, and efficacy of drugs, cosmetics, and medical devices. Its responsibilities and oversight extend to the regulation of the import, manufacture, distribution, and sale of these products.

In the medical device industry, manufacturing licenses are integral to this oversight. They ensure that only quality devices enter the marketplace, thus safeguarding patient safety. One such device is the Ultraviolet (UV) radiation environmental disinfection device, a vital tool in healthcare settings.

Before proceeding further CDSCO's portal is a great resource to delve deeper into the workings of CDSCO and the various regulatory compliances in place.

What is Ultraviolet (UV) radiation environmental disinfection device?

An Ultraviolet (UV) radiation environmental disinfection device is a specialized medical device used for disinfection in healthcare settings. This device uses ultraviolet radiation to destroy or inactivate bacteria and other harmful microorganisms, creating a safer environment for patients.

This device is a common presence in many healthcare institutions, particularly hospitals and clinics, and forms a crucial part of their infection prevention strategies.

The Role of CDSCO in Medical Device Regulation

Established to protect and promote public health, CDSCO is the apex regulatory body in India for drugs, cosmetics, and medical devices. Its regulatory framework includes stringent quality control over the production, import, and export of these products - including medical devices.

How to manufacture Ultraviolet (UV) radiation environmental disinfection device

Manufacturing an Ultraviolet (UV) radiation environmental disinfection device requires technical expertise and regulatory compliance. As a Class B device, it comes under the purview of CDSCO's MD5 regulatory license.

Fees for manufacturing license for Ultraviolet (UV) radiation environmental disinfection device

The costs involved in obtaining an MD5 license include a flat fee of INR 5,000 for the license itself and an additional INR 500 per product. MD5 License Detail

Why is a Manufacturing License Necessary for Ultraviolet (UV) radiation environmental disinfection device?

Obtaining a manufacturing license is mandatory for producing medical devices such as the Ultraviolet (UV) radiation environmental disinfection device under CDSCO's regulations. This ensures product quality and safety, protecting consumers and patients from substandard products.

Steps to Obtain a CDSCO Manufacturing License for Ultraviolet (UV) radiation environmental disinfection device

  • Detailed documentation, including Device Master File, Quality Management Certificate, Device Details, and Site details
  • Submission of application for manufacturing license
  • Undergoing the approval process
  • Successfully overcoming common challenges in the process

Frequently Asked Questions (FAQs)

Q.. What is the risk class of Ultraviolet (UV) radiation environmental disinfection device as per Medical Device Rules, 2017?

  • The device falls under Risk Class B.

Q.. What license in needed to manufacture Ultraviolet (UV) radiation environmental disinfection device?

  • An MD5 license is required for manufacturing this device.

Q.. What is the fee for MD5 license for Ultraviolet (UV) radiation environmental disinfection device?

  • The fee for an MD5 license includes a base fee of INR 5,000 and an additional INR 500 per product.

Q.. Who will issue the manufacturing license for Ultraviolet (UV) radiation environmental disinfection device?

  • For Class A sterile and measuring & Class B devices, the state FDA will issue the license.

Q.. Is repackaging of Ultraviolet (UV) radiation environmental disinfection device considered manufacturing?

  • Yes, as per 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 Drug Act only and hence repackaging of Ultraviolet (UV) radiation environmental disinfection device is also considered manufacturing requiring an MD5 license.

Conclusion

Navigating the process of obtaining a manufacturing license for medical devices like the Ultraviolet (UV) radiation environmental disinfection device can be complex. At Pharmadocx Consultants, we are here to help. Reach out to us for consultation or assistance at "+91-7404557227," or email us at [email protected].

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