CDSCO Manufacturing License for Enteral tube extension, non-sterile

Introduction

The Central Drugs Standard Control Organization (CDSCO) plays a vital role in regulating medical devices in India. The manufacturing licenses granted by CDSCO ensures the safety and quality of these devices and protect patients from substandard products. Today's discussion revolves around a Class B device - the Enteral tube extension, and the significance of its licensing in the medical field.

The manufacturing of Enteral tube extension, a non-sterile device intended for increasing the length of tubing during enteral feeding/medication administration or aspiration, requires a CDSCO license. For more details on CDSCO and its licensing process, head to CDSCO's portal here

• What is Enteral tube extension, non-sterile?
• The Role of CDSCO in Medical Device Regulation
• How to Manufacture Enteral Tube Extension, Non-Sterile
• Fees for Manufacturing License for Enteral Tube Extension, Non-Sterile
• Why is a Manufacturing License Necessary for Enteral Tube Extension, Non-Sterile?
• Steps to Obtain a CDSCO Manufacturing License for Enteral Tube Extension, Non-Sterile
• Frequently Asked Questions (FAQs)
• Conclusion

What is Enteral tube extension, non-sterile?

An Enteral tube extension is a thin, flexible tube designed for extracorporeal connection to an enteral feeding tube during enteral feeding, medication administration, or aspiration. Its main objective is to increase the distance between the patient and the oral/enteral device, making the process more manageable and less invasive for patients. This device, commonly found in gastroenterology, plays a crucial role in patient care, especially those needing long-term enteral feeding.

The Role of CDSCO in Medical Device Regulation

The CDSCO, under the Ministry of Health & Family Welfare, is the primary regulatory body for drugs and medical devices in India. Its mission is to safeguard and enhance public health by ensuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices. The regulation of medical devices, including the Enteral tube extension, falls under CDSCO's scrutiny, ensuring all manufacturers adhere to standards and licensing requirements to maintain patient safety.

How to Manufacture Enteral Tube Extension, Non-Sterile

The manufacturing process of an Enteral tube extension must abide by CDSCO's guidelines and require an MD5 license. These requirements and licenses ensure the products' quality and safety when used in a healthcare setting.

Fees for Manufacturing License for Enteral Tube Extension, Non-Sterile

The manufacturing license for a Class B device, such as the Enteral tube extension, is MD5. The fee structure for applying for an MD5 license is Rs. 5,000 for the license and an additional Rs. 500 per product.

Why is a Manufacturing License Necessary for Enteral Tube Extension, Non-Sterile?

Like other medical devices, the Enteral tube extension also requires a manufacturing license. It's mandatory for manufacturers to obtain this license to ensure quality and safety. This license also plays a crucial role in regulatory compliance and protecting consumers and patients from substandard products.

Steps to Obtain a CDSCO Manufacturing License for Enteral Tube Extension, Non-Sterile

Acquiring a manufacturing license requires careful preparation and submission of the following documents: Device Master File, Quality Management Certificate, Device Details, Site details, among others. Once these documents are submitted, the application process involves submission, review, and finally, approval. Though there may be challenges along the way but with proper guidance and adherence to regulations, manufacturers can smoothly navigate this process.

Please find more about the process in https://pharmadocx.com/md-5-licesne-class-a-b-medical-devices/

Frequently Asked Questions (FAQs)

1. What is the risk class of Enteral tube extension as per Medical Device Rules, 2017? The risk class of Enteral tube extension is Class B.
2. What license is needed to manufacture Enteral tube extension? The required license to manufacture Enteral tube extension is MD5.
3. What is the fee for the MD5 license for Enteral tube extension? The fee for the MD5 license for Enteral tube extension is Rs. 5,000 for the license and Rs. 500 per product.
4. Who will issue the manufacturing license for Enteral tube extension? The manufacturing license for Class B devices like Enteral tube extension are issued by the state FDA.
5. Is repackaging of Enteral tube extension 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. Therefore, repackaging of Enteral tube extension is also considered manufacturing requiring a license on MD5.

Conclusion

Understanding CDSCO regulations and acquiring the appropriate manufacturing license is crucial for medical device manufacturing. Seek expert consultation or assistance at Pharmadocx Consultants for the licensing process. Reach out at Pharmadocx Consultants, call on "+91-7404557227" or email to [email protected] for further guidance.