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CDSCO Manufacturing License for Ultraviolet lamp for dermatologic disorders.

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Introduction

The Central Drugs Standard Control Organization (CDSCO) acts as a pivotal institution in the Indian healthcare sector, responsible for safeguarding public health and ensuring the quality of medical devices reaching the market. As the national regulatory body for pharmaceuticals and medical devices, CDSCO oversees all aspects of manufacturing and marketing approval, setting standards, and ensuring compliance with regulatory requirements.

Every medical device manufactured in India must be overseen by CDSCO and attain a manufacturing license. This includes the Ultraviolet lamp for dermatologic disorders, a crucial device with significant medical implications. To seek more information or to apply for the manufacturing license, visit the CDSCO portal.

What is an Ultraviolet lamp for dermatologic disorders?

The Ultraviolet lamp for dermatologic disorders, referring to a device that provides ultraviolet radiation (UV light) targeted towards the body, is used to photo activate a drug meant for treating dermatologic disorders. These UV lamps are essential components in procedures involving phototherapy, aiding in the treatment of skin conditions such as psoriasis, vitiligo, and acne. When a photosensitizing drug is applied, the UV light from these lamps helps activate the medicine, promoting skin healing.

The Role of CDSCO in Medical Device Regulation

CDSCO plays a critical role in the regulation of medical devices in India. It upholds the mission of safeguarding public health by ensuring the safety, quality, and therapeutic effectiveness of medical devices, alongside drugs, cosmetics, and diagnostics. CDSCO has established a comprehensive regulatory framework to control and monitor the lifecycle of medical devices, from manufacturing to distribution and usage, ensuring a robust check on their safety and efficacy.

How to manufacture an Ultraviolet lamp for dermatologic disorders

Fees for manufacturing license for Ultraviolet lamp for dermatologic disorders

As an Ultraviolet lamp for dermatologic disorders falls under the Class B risk category, manufacturers are required to acquire an MD5 license. The fee for obtaining this license is Rs. 5,000, along with an additional fee of Rs. 500 per product. For further details, refer to this article.

Why is a Manufacturing License Necessary for an Ultraviolet lamp for dermatologic disorders?

Acquiring a manufacturing license is mandatory for producing these devices, as it provides an assurance of their quality and safety. This licensing plays a crucial role in the healthcare sector, allowing regulatory bodies to ensure only products meeting the requisite standards reach the market. Additionally, it ensures the protection of patients and consumers from substandard or potentially harmful products.

Steps to Obtain a CDSCO Manufacturing License for an Ultraviolet lamp for dermatologic disorders

  1. Preparation of necessary documentation: This includes the Device Master File, Quality Management Certificate, specific details about the device, and site details.
  2. Submission of the application to the appropriate authority.
  3. Await response and approval.
  4. Overcoming potential challenges that may arise during the process.

Frequently Asked Questions (FAQs)

Q1. What is risk class of Ultraviolet lamp for dermatologic disorders as per Medical Device Rules, 2017?

The Ultraviolet lamp for dermatologic disorders falls under risk class B.

Q2. What license is needed to manufacture Ultraviolet lamp for dermatologic disorders?

An MD5 license is needed to manufacture Ultraviolet lamp for dermatologic disorders.

Q3. What is fees for MD5 license for Ultraviolet lamp for dermatologic disorders?

The fees for MD5 license is Rs. 5,000, with an additional Rs. 500 per product.

Q4. Who will issue manufacturing license for Ultraviolet lamp for dermatologic disorders?

The license for Class B devices like the Ultraviolet lamp for dermatologic disorders is issued by the state FDA.

Q4. Is repackaging of Ultraviolet lamp for dermatologic disorders considered manufacturing?

Yes, as per the Drugs and Cosmetics Act's definition, repackaging of drugs and medical devices is considered manufacturing. This means that repackaging of Ultraviolet lamp for dermatologic disorders will require an MD5 license.

Conclusion

The process of obtaining a manufacturing license from CDSCO involves several steps and thorough documentation. It can be a daunting challenge for those unfamiliar with the process. This is where Pharmadocx Consultants can help. Reach out to our team for assistance or consultation regarding the CDSCO licensing process. Visit our website Pharmadocx Consultants, call us at +91-7404557227, or send us an email at [email protected]. We are more than willing to guide you through this process.

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