CDSCO Manufacturing License for Enteral tube extension, sterile

Introduction

The Central Drugs Standard Control Organization (CDSCO) carries immense importance in the field of medical devices in India. Being the apex regulatory body for pharmaceuticals and medical devices, the CDSCO has a vital role to play in ensuring the safety and efficacy of these products on the market. All manufacturers, distributors, and importers of medical devices must acquire appropriate manufacturing licenses from CDSCO to assure the quality of their products and adhere to regulatory compliances.

Among various medical instruments, the Enteral tube extension holds significant medical value. It is a sterile, thin, flexible tube meant for extracorporeal connection to an enteral feeding tube (such as a nasogastric tube). Its primary role is to enhance the length of tubing from the patient to an oral/enteral device like a syringe during the administration of medication or enteral feeding or aspiration.

For more details, please visit CDSCO's portal here

• What is Enteral tube extension?
• The Role of CDSCO in Medical Device Regulation
• How to manufacture Enteral tube extension
• Fees for manufacturing license for Enteral tube extension
• Why is a Manufacturing License Necessary for Enteral tube extension?
• Steps to Obtain a CDSCO Manufacturing License for Enteral tube extension
• Frequently Asked Questions (FAQs)
• Conclusion

What is Enteral tube extension?

An Enteral tube extension is a medical device used prominently in gastroenterology. As a sterile, thin, and flexible piece of equipment, it serves to extend the length of an enteral feeding tube. This added length becomes extremely beneficial in situations of enteral feeding/medication administration or aspiration, where a lengthier extracorporeal connection is required. Enteral tube extensions play a crucial role in patient care and contribute significantly to successful medical procedures.

The Role of CDSCO in Medical Device Regulation

The CDSCO plays a comprehensive role in the regulation of medical devices in India. Founded with a mission to safeguard and improve the nation’s public health system, it oversees the safety, efficacy, and quality of pharmaceuticals, medical devices, and cosmetics across the country. CDSCO's regulatory framework encompasses strict rules and guidelines that manufacturers must adhere to, ensuring that all medical devices, including the Enteral tube extension, comply with stringent standards.

How to manufacture Enteral tube extension

Manufacturing medical devices like Enteral tube extensions requires adherence to rigorous guidelines specified by CDSCO. It involves a series of steps, including process planning, material procurement, adherence to quality standards, final assembly, and thorough inspection.

Fees for manufacturing license for Enteral tube extension

As the Enteral tube extension falls under risk class-B, an MD5 license is required for its manufacturing. The fees for an MD5 license are Rs. 5,000 for the license and an additional Rs. 500 per product.

Why is a Manufacturing License Necessary for Enteral tube extension?

Acquiring a manufacturing license for any medical device, including an Enteral tube extension, is mandatory. This requirement stems from the need to maintain quality and safety in medical device production. Regulatory compliance is crucial in the healthcare sector to avert any potential harm from substandard products to patients and customers.

Steps to Obtain a CDSCO Manufacturing License for Enteral tube extension

1. Start with gathering necessary documents like Device Master File, Quality Management Certificate, Device Details, Site details, etc.
2. Submit these documents as part of your application to CDSCO.
3. Wait for the review process, wherein your application will be scrutinized for its compliance.
4. Upon successful review, the license will be approved and issued.

For in-depth information about MD5 licensing requirements, follow this link

Frequently Asked Questions (FAQs)

Q1. What is risk class of Enteral tube extension as per Medical Device Rules, 2017?

• Enteral tube extension comes under risk class B as per the Medical Device Rules, 2017.

Q2. What license is needed to manufacture Enteral tube extension?

• An MD5 license is required to manufacture Enteral tube extension.

Q3. What is the fee for an MD5 license for Enteral tube extension?

• The fee for an MD5 license for an Enteral tube extension is Rs. 5,000 for the license and an additional Rs. 500 per product.

Q4. Who will issue a manufacturing license for Enteral tube extension?

• For Class A sterile and measuring & Class B devices including Enteral tube extension, the state FDA will issue the manufacturing license.

Q5. Is repackaging of Enteral tube extension considered manufacturing?

• Yes. As per Drugs and Cosmetics Act's definition of manufacturing, repackaging of medical devices is considered manufacturing. Hence, the repackaging of Enteral tube extension would also require an MD5 license.

Conclusion

Dealing with the licensing process can seem daunting, but with appropriate guidance and consultation, one can effortlessly navigate the process. Pharmadocx Consultants are always here to assist you in obtaining your CDSCO Manufacturing license for medical devices like Enteral tube extension. Reach out to us here, call us at +91-7404557227 or drop an email at [email protected], and we'd be more than happy to help you.