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CDSCO Manufacturing License for Paediatric-temperature nasogastric/orogastric tube

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Introduction

The Central Drugs Standard Control Organization (CDSCO) plays a paramount role in maintaining the health and wellbeing of citizens in India. The organization's primary duty is to ensure that drugs, cosmetics, and medical devices available in the market uphold the standards of quality and safety. The CDSCO's responsibilities do not stop at drugs and cosmetics, the organization's extensive oversight extends to medical devices too. Understanding the critical role medical devices play in health care, the CDSCO pays keen attention to the manufacturing, sales, and distribution of these devices.

One prominent device that falls under this regulatory oversight is the Paediatric-temperature nasogastric/orogastric tube. This medical device has significant importance in paediatric and neonatal care. The role of this device and the licensing required for its manufacturing is what we delve into in this blog post.

To get started, you can take a look at the CDSCO portal.

What is Paediatric-temperature nasogastric/orogastric tube?

A Paediatric-temperature nasogastric/orogastric tube is a specialised medical device designed for paediatric or neonatal enteral feeding. Its integrated temperature sensor continuously measures the oesophageal temperature. Its sterile, thin, flexible, hollow design makes it suitable for feeding and measuring the temperature in infants simultaneously.

The Role of CDSCO in Medical Device Regulation

The CDSCO was established with a mission to safeguard and enhance public health by ensuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices. One critical aspect of fulfilling this mission is the regulation of medical devices in the country. The CDSCO provides a comprehensive regulatory framework for medical devices to ensure manufacturing units meets standard specifications and quality guidelines for device production.

How to manufacture Paediatric-temperature nasogastric/orogastric tube

To produce a Paediatric-temperature nasogastric/orogastric tube, the medical device industry needs to follow standard specifications and guidelines as per CDSCO regulatory policy. Adherence to such rules ensures the safety and quality of the medical equipment, which is essential for the health of the patients.

Fees for manufacturing license for Paediatric-temperature nasogastric/orogastric tube

For Risk Class C devices like the Paediatric-temperature nasogastric/orogastric tube, an MD9 license is needed. The fees for MD9 license are Rs. 50,000 for the license and Rs.1,000 per product.

Why is a Manufacturing License Necessary for Paediatric-temperature nasogastric/orogastric tube?

It is crucial to acquire a manufacturing license for producing the Paediatric-temperature nasogastric/orogastric tube. The license is a clear indicator of the commitment to quality and safety in medical device production. Further, it ensures regulatory compliance in the healthcare sector, thereby protecting consumers and patients from substandard products.

Steps to Obtain a CDSCO Manufacturing License for Paediatric-temperature nasogastric/orogastric tube

  1. Gather the required documents such as the Device Master File, Quality Management Certificate, Device Details, Site details etc.
  2. Submit the application with needed documents.
  3. Go through the review process of the application.
  4. Finally, get the approval and the license.

Though the process may seem straightforward, it can come with certain challenges. But don’t worry! These can be overcome with the right guidance and expertise.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of the Paediatric-temperature nasogastric/orogastric tube as per Medical Device Rules, 2017?

Class C.

Q2. What license in needed to manufacture the Paediatric-temperature nasogastric/orogastric tube?

MD9 license.

Q3. What is fees for the MD9 license for Paediatric-temperature nasogastric/orogastric tube?

Fees for MD9 license are Rs. 50,000 for the license and Rs.1,000 per product.

Q4. Who will issue manufacturing license for Paediatric-temperature nasogastric/orogastric tube?

For class C medical devices like Paediatric-temperature nasogastric/orogastric tube, the CDSCO HQ in New Delhi will issue the license.

Q5. Is repackaging of Paediatric-temperature nasogastric/orogastric tube 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 the Drug Act only, hence repackaging of the Paediatric-temperature nasogastric/orogastric tube is also considered manufacturing requiring a license on MD9.

Conclusion

Obtaining a manufacturing license for certain medical devices such as the Paediatric-temperature nasogastric/orogastric tube might be a daunting task without proper guidance and understanding. We, at Pharmadocx Consultants, have the required expertise to guide you step by step through the application process, helping you understand and overcome common challenges in licensing.

In case you're in need of getting a manufacturing license for risk class C medical devices, requiring an MD9 license, click here for more information or reach out to us for consultation at Pharmadocx Consultants or call us at +91-7404557227 or drop us an email at [email protected].

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