CDSCO Manufacturing License for Long-term use enterostomy feeding tube

Introduction

The Central Drugs Standard Control Organization (CDSCO), the national regulatory body for Indian pharmaceuticals and medical devices, regulates the safety, efficacy, and quality of items listed under the Drugs and Cosmetics Act, 1940. It also regulates the standards of imported pharmaceuticals and medical devices for sale, import, and distribution across India.

Manufacturing licenses play a vital role in the medical device industry, ensuring the quality and safety of products used in medical treatments. These licenses stand as a guarantee of successful regulatory compliance and protect consumers from unfair trade practices and hazardous or substandard products.

Today, we focus on the 'Long-term use enterostomy feeding tube'. This medical equipment is crucial for patients requiring long-term enteral nutrition. It is inserted surgically in the stomach or small intestine.

For more details, please refer to the official CDSCO portal here

• What is a Long-term use Enterostomy Feeding Tube?
• The Role of CDSCO in Medical Device Regulation
• How to Manufacture Long-term use Enterostomy Feeding Tube
• Fees for Manufacturing License for Long-term use Enterostomy Feeding Tube
• Why is a Manufacturing License Necessary for Long-term use Enterostomy Feeding Tube?
• Steps to Obtain a CDSCO Manufacturing License for Long-term use Enterostomy Feeding Tube
• Frequently Asked Questions (FAQs)
• Conclusion

What is a Long-term use Enterostomy Feeding Tube?

A Long-term use enterostomy feeding tube is a medical device used for the administration of nutrition directly into the stomach or small intestine. The tube is surgically inserted through the abdominal wall into the stomach or small intestine and is intended for long-term use.

These tubes are commonly used in cases of serious illness where oral intake is not possible or sufficient. They provide essential nutrients and medication directly to the patient’s digestive system, bypassing the mouth and esophagus.

The Role of CDSCO in Medical Device Regulation

The CDSCO has been pivotal in ensuring the quality and safety of medical devices in India. Its primary mission is to protect and promote public health in India by enforcing the Drugs and Cosmetics Act and its relevant rules.

CDSCO's role extends to the regulation of the manufacture, sale, and distribution of medical devices across India. It provides guidelines and standards for manufacturing, clinical investigation, and in-country testing of medical devices, ensuring that these devices meet the highest standards of safety and efficacy.

How to Manufacture Long-term use Enterostomy Feeding Tube

The manufacture of a long-term use enterostomy feeding tube involves intricate procedures and strict regulations to ensure its safety and functionality. Producers must adhere to the manufacturing license requirements put forth by CDSCO.

Fees for Manufacturing License for Long-term use Enterostomy Feeding Tube

For a Class C device like the long-term use enterostomy feeding tube, the MD9 license is required. The fee for MD9 is Rs. 50,000 for the license and Rs. 1,000 per product.

Why is a Manufacturing License Necessary for Long-term use Enterostomy Feeding Tube?

It is mandatory to have a manufacturing license for medical devices in India. The key reasons include:

• Ensuring the quality and safety of the product, thereby reducing the risk to patients.
• Adhering to regulatory compliance which is essential in the healthcare sector.
• Protecting consumers from sub-standard products.

Steps to Obtain a CDSCO Manufacturing License for Long-term use Enterostomy Feeding Tube

The process of acquiring a CDSCO manufacturing license involves:

• Gathering and preparing all necessary documents including the Device Master File, Quality Management Certificate, detailed device specifications and site details.
• Submitting the completed application along with the necessary fees.
• Undergoing review and assessment by the competent authority.
• Upon successful review, the manufacturing license will be issued.

Frequently Asked Questions (FAQs)

1. What is the risk class of the Long-term use enterostomy feeding tube as per Medical Device Rules, 2017?
   The Long-term use enterostomy feeding tube falls under Risk Class C.

2. What license is needed to manufacture the Long-term use enterostomy feeding tube?
   The MD9 license is required for manufacturing the Long-term use enterostomy feeding tube.

3. What is the fee for the MD9 license for the Long-term use enterostomy feeding tube?
   The fee is Rs. 50,000 for the license and Rs. 1,000 per product.

4. Who will issue the manufacturing license for Long-term use enterostomy feeding tube?
   The manufacturing license for Risk Class C & D devices will be issued by CDSCO HQ in New Delhi.

5. Is repackaging of Long-term use enterostomy feeding tube considered manufacturing?
   Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. As medical devices are also classified under drugs, the repackaging of the Long-term use enterostomy feeding tube is also considered manufacturing, requiring an MD9 license.

Conclusion

We hope this guide provides valuable insights on understanding CDSCO's specific regulations and licensing for manufacturing medical devices, especially the Long-term use enterostomy feeding tube. It's critical to adhere to these regulations for ensuring quality, safety, and compliance.

For further assistance or consultation regarding the licensing process, we recommend reaching out to Pharmadocx Consultants or call [ +91-7404557227]. For email enquires, address to [email protected].

By providing the right support and knowledge, we aim to make the process of obtaining manufacturing licenses easier and hassle-free. For more details on the MD9 license, please refer to this comprehensive article here.