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CDSCO Manufacturing License for Nitric oxide delivery unit

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is the principal regulating body in India responsible for the safety, quality, and efficacy of drugs and medical devices. It works under the aegis of the Ministry of Health and Family Welfare, Government of India. One pivotal function of CDSCO is to provide licenses to different categories of medical devices' manufacturers, with the overarching goal of ensuring the safety, efficacy and quality of medical devices produced in the country.

The manufacturing of a medical device like the Nitric Oxide Delivery Unit, also bears this similar regulatory oversight. The Nitric Oxide Delivery Unit is a crucial medical invention with immense therapeutic significance, especially for those afflicted with severe respiratory disorders. For further insights into the CDSCO and its regulatory framework, you can explore their official portal.

What is Nitric Oxide Delivery Unit?

In the realm of medical devices, the Nitric Oxide Delivery Unit holds a key position. It is a specially designed device meant for delivering precise quantities of nitric oxide, also scientifically referred to as nitrogen monoxide, into the respiratory tract of patients - neonates, adult as well as pediatric. The primary rationale behind this is to help in the treatment of severe respiratory disorders.

The Role of CDSCO in Medical Device Regulation

Since its inception, CDSCO has been ardently involved in the regulation of medical devices in India. It formulates the operational regulatory framework, approves new medical devices, monitors the safety of the approved devices and evaluates their performance. All this is done with the objective of protecting and promoting public health.

How to manufacture Nitric Oxide Delivery Unit

Manufacturing of Nitric Oxide Delivery Unit requires adherence to high standards of quality and safety, which are stringently monitored by CDSCO.

Fees for manufacturing license for Nitric Oxide Delivery Unit

To manufacture the Nitric Oxide Delivery Unit, which falls under the class B category of medical devices, a license MD5 is required. The fee for obtaining this license is Rs. 5,000 and there is an additional cost of Rs. 500 per product.

Why is a Manufacturing License Necessary for Nitric Oxide Delivery Unit?

Medical devices like the Nitric Oxide Delivery Unit demand compulsory manufacturing licensing for several reasons. Primarily, to ensure high-quality standards and infallible safety in their production but also to ensure regulatory compliance within the healthcare sector. This also guards consumers and patients from exposure to substandard products.

Steps to Obtain a CDSCO Manufacturing License for Nitric Oxide Delivery Unit

Applying and obtaining a CDSCO manufacturing license involves few important stages, such as pre-requisites and documentation, application submission, and approval. Key required documents include Device Master File, Quality Management Certificate, Device Details, Site details, etc. The overall process though simple can involve challenges that can be skillfully navigated with experienced assistance.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Nitric Oxide Delivery Unit as per Medical Device Rules, 2017?

Risk Class for Nitric oxide delivery unit is Class B.

Q2. What license is needed to manufacture Nitric Oxide Delivery Unit?

To manufacture Nitric Oxide Delivery Unit, a MD5 license is needed.

Q3. What is the fee for MD5 license for Nitric Oxide Delivery Unit?

The fee for an MD5 license for Nitric Oxide Delivery Unit is Rs. 5,000 for the license and Rs. 500 per product.

Q4. Who will issue manufacturing license for Nitric Oxide Delivery Unit?

For Class B devices like Nitric Oxide Delivery Unit, the state FDA will issue the license.

Q5. Is repackaging of Nitric Oxide Delivery Unit 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 Nitric Oxide Delivery Unit is also considered manufacturing which requires an MD5 license.

Conclusion

Obtaining a manufacturing license requires knowledge of the underlying rules and nuances involved in the process which is where professional consultancy finds relevance. Teams like Pharmadocx Consultants are well-versed to guide you through the licencing process. Reach out to Pharmadocx Consultants either on call at +91-7404557227 or through email at "[email protected]" for a comprehensive consultation. For more information on MD5 manufacturing license, here is a helpful article.

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