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CDSCO Manufacturing License for Enteral feeding tube clearing kit

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Introduction

Central Drugs Standard Control Organization (CDSCO) is the key regulatory body for the medical device industry in India. It plays a crucial role in ensuring the safety and efficacy of medical devices manufactured in the country. One of the areas under its purview is the issue of manufacturing licenses, which are pivotal for maintaining standard quality and control in the production of medical devices.

An intriguing example of a medical device is an Enteral feeding tube clearing kit. This device is a significant part of gastroenterology and plays a fundamental role in the management of the nutritional requirement of patients unable to take food orally. More details about this device, its intended usage, and licensing process can be found on CDSCO's portal.

What is an Enteral feeding tube clearing kit?

Enteral feeding tube clearing kit is a medical device utilized to maintain the luminal patency of an in situ enteral feeding tube. Its primary objective is to prevent or remove, through biochemical action, an enteral formula clog. This kit is extensively used in the medical field, primarily in gastroenterology, to ensure the smooth and uninterrupted flow of nutritional supplements to patients who are unable to consume food orally.

The Role of CDSCO in Medical Device Regulation

CDSCO, is driven by its mission to protect and promote public health. It has a comprehensive regulatory framework, the crux of which includes licensing, which is designed to ensure the quality of medical devices manufactured in India.

How to manufacture Enteral feeding tube clearing kits

Manufacturing an Enteral feeding tube clearing kit stands on three pillars - Quality, Safety, and Efficacy. These are strictly maintained and monitored as per the regulations and guidelines issued by CDSCO.

Fees for manufacturing license for Enteral feeding tube clearing kits

For Class B devices like the Enteral feeding tube clearing kit, the license required is MD5. The fees for MD5 license are Rs. 5,000, and an additional Rs. 500 per product.

Why is a Manufacturing License Necessary for Enteral feeding tube clearing kits?

Securing a manufacturing license is mandatory for manufacturing medical devices in India. This is not only critical to ensure the quality and safety of the products but also pivotal for maintaining regulatory compliance in the healthcare sector. Adhering to these norms ensures that substandard products do not reach the consumers, safeguarding the health and interests of the patients.

Steps to Obtain a CDSCO Manufacturing License for an Enteral feeding tube clearing kit

Obtaining a CDSCO manufacturing license involves the following steps:

  1. Collate all necessary documentation (Device Master File, Quality Management Certificate, Device Details, Site details, etc.)
  2. Submit the application
  3. Await approval from CDSCO
  4. Overcome any potential challenges with the help of expert consultants

For a more detailed guide on procuring a MD5 license, please refer to this article

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Enteral feeding tube clearing kit as per Medical Device Rules, 2017?

The Enteral feeding tube clearing kit falls under Risk Class B as per the Medical Device Rules, 2017.

Q2. What license is needed to manufacture Enteral feeding tube clearing kit?

You need the MD5 license to manufacture the Enteral feeding tube clearing kit.

Q3. What is the fee for MD5 license for Enteral feeding tube clearing kit?

The fees for the MD5 license are Rs. 5,000 and an additional Rs. 500 per product.

Q4. Who will issue the manufacturing license for Enteral feeding tube clearing kit?

The state FDA will issue the license for Class B devices like Enteral feeding tube clearing kit.

Q5. Is repackaging of Enteral feeding tube clearing kit 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 Enteral feeding tube clearing kit is also considered manufacturing requiring an MD5 license.

Conclusion

Securing a Manufacturing License for Enteral feeding tube clearing kit might seem daunting, but with expert assistance, you can traverse this road seamlessly. Reach out to the trusted and reliable consultants at Pharmadocx Consultants for all your licensing needs. You can also call at +91-7404557227 or send an email to [email protected] for any queries or assistance.

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