CDSCO Manufacturing License for Thermal-regulation orogastric tube

Introduction

The Central Drugs Standard Control Organization (CDSCO) plays a critical role in the healthcare sector in India. It serves as the national regulatory body for Indian pharmaceuticals and medical devices. The CDSCO's functions include maintaining quality control, approving licenses for manufacturing, and regulatory compliance of all medical devices in India.

In the medical device industry, obtaining manufacturing licenses for producing healthcare equipment is of utmost importance. It ensures the production of high-quality, safe devices for medical procedures. One such essential medical device is the Thermal-regulation orogastric tube.

The Thermal-regulation orogastric tube carries significant medical value, enabling oral introduction into the gastrointestinal (GI) tract for enteral feeding, gastric decompression, and thermal regulation of the body. For all the regulatory information related to the manufacturing of this device, you can refer to CDSCO's portal here.

• What is Thermal-regulation Orogastric Tube?
• The Role of CDSCO in Medical Device Regulation
• How to manufacture Thermal-regulation Orogastric Tube
• Fees for manufacturing license for Thermal-regulation Orogastric Tube
• Why is a Manufacturing License Necessary for the Thermal-regulation Orogastric Tube?
• Steps to Obtain a CDSCO Manufacturing License for Thermal-regulation Orogastric Tube
• Frequently Asked Questions (FAQs)
• Conclusion

What is Thermal-regulation Orogastric Tube?

The Thermal-regulation orogastric tube is a non-sterile, multi-lumen, multi-purpose tube. It is designed for oral introduction into the gastrointestinal (GI) tract. The tube serves two purposes: enteral feeding/gastric decompression and thermal regulation of the body. It works by enabling thermal transfer across the oesophagus, modulating the core body temperature — both lowering and elevating it.

The Role of CDSCO in Medical Device Regulation

CDSCO has been dutifully performing its mission to protect and promote public health in India. It does so by regulating the quality of drugs and medical devices through a regulatory framework. This framework consists of guidelines and standards that ensure the safety and efficacy of these healthcare products.

How to manufacture Thermal-regulation Orogastric Tube

The manufacturing of a thermal-regulation orogastric tube involves a series of steps adhering to the stringent standards set by CDSCO. It requires a Class C license, i.e., MD9, because it is categorized under Risk Class C.

Fees for manufacturing license for Thermal-regulation Orogastric Tube

The fees for obtaining the MD9 license required for the production of the thermal-regulation orogastric tube is Rs. 50,000. Additionally, a fee of Rs. 1,000 per product is also levied.

Why is a Manufacturing License Necessary for the Thermal-regulation Orogastric Tube?

Obtaining a manufacturing license is mandatory for producing the thermal-regulation orogastric tube. This license ensures quality and safety in its production, upholding the reputation of the healthcare sector by following regulatory compliance. It also protects consumers and patients from substandard products.

Steps to Obtain a CDSCO Manufacturing License for Thermal-regulation Orogastric Tube

Acquiring a manufacturing license involves several steps like submitting the necessary documents such as the Device Master File, Quality Management Certificate, Device Details, and Site details. The application then moves from submission to approval. There may be several challenges during this process, but effective strategies can help overcome them.

Frequently Asked Questions (FAQs)

1. What is the risk class of Thermal-regulation Orogastric Tube as per Medical Device Rules, 2017?

   The Thermal-regulation orogastric tube comes under Risk Class C.

2. What license is needed to manufacture Thermal-regulation Orogastric Tube?

   The MD9 license is needed for manufacturing the Thermal-regulation orogastric tube.

3. What is fees for MD9 license for Thermal-regulation Orogastric Tube?

   The fee for an MD9 license is Rs. 50,000. Additionally, Rs. 1,000 per product is also charged.

4. Who will issue manufacturing license for Thermal-regulation Orogastric Tube?

   The CDSCO HQ in New Delhi will issue the MD9 license for manufacturing the Thermal-regulation orogastric tube.

5. Is repackaging the Thermal-regulation Orogastric Tube considered manufacturing?

   Yes, as per the Drugs and Cosmetics Act, repackaging of the Thermal-regulation orogastric tube is considered manufacturing and it requires the MD9 license.

Conclusion

Licensing in the healthcare sector can be a complex process, but experts at Pharmadocx Consultants are here to help. Reach out for a consultation or assistance with the licensing process. Visit Pharmadocx Consultants or directly call at +91-7404557227 or send us an email at [email protected]. You can learn more about the Class C MD9 license for manufacturing medical devices from this article. Remember, consistency in maintaining the highest standards in healthcare is our foremost priority. Rest assured, we offer the best in class services to support you in your journey of saving lives through quality healthcare!