CDSCO Manufacturing License for Oesophageal temperature monitor

Introduction

The importance of regulatory bodies cannot be overstated in the medical device industry, primarily the Central Drugs Standard Control Organization (CDSCO). The CDSCO ensures the safety, efficacy, and quality of medical devices supplied and manufactured in India. In this blog post, we'll introduce you to the CDSCO's role and the significance of manufacturing licenses using the Oesophageal temperature monitor as an example. This device plays an essential part in medical procedures, especially in surgical ablation of the left atrium. More information regarding CDSCO's regulation can be found on their portal here.

• What is Oesophageal Temperature Monitor?
• The Role of CDSCO in Medical Device Regulation
• How to Manufacture Oesophageal Temperature Monitor
• Fees for Manufacturing License for Oesophageal Temperature Monitor
• Why is a Manufacturing License Necessary Oesophageal Temperature Monitor
• Steps to Obtain a CDSCO Manufacturing License for Oesophageal Temperature Monitor
• Frequently Asked Questions (FAQs)
• Conclusion

What is Oesophageal Temperature Monitor?

The Oesophageal Temperature Monitor is an electronic device explicitly designed for monitoring oesophageal temperature during surgical procedures. It is primarily utilized during surgical ablation of the left atrium wall. The monitor measures the oesophageal temperature at several adjacent levels, with the temperature readings displayed simultaneously, aiding the surgeon to avoid application of excessive heat, potentially forming an atrial-oesophageal fistula.

The Role of CDSCO in Medical Device Regulation

The Central Drugs Standard Control Organization (CDSCO) has a longstanding history of ensuring the safety and efficacy of drugs and medical devices manufactured and supplied in India. They have a regulatory framework specifically designed for medical devices, ensuring adherence to quality standards and customer safety.

How to Manufacture Oesophageal Temperature Monitor

To manufacture the Oesophageal Temperature Monitor, a license is a mandatory requirement. As per the risk classification provided by CDSCO, the Oesophageal Temperature Monitor falls within Class B, requiring an MD5 manufacturing license.

Fees for Manufacturing License for Oesophageal Temperature Monitor

The MD5 manufacturing license fee for this device is Rs. 5,000, with an additional Rs. 500 per product. For more information regarding the MD5 license, visit pharmadocx.

Why is a Manufacturing License Necessary Oesophageal Temperature Monitor

Having a manufacturing license ensures quality and safety in the production of the Oesophageal Temperature Monitor. It aids in maintaining regulatory compliance and plays an essential role in protecting consumers and patients from substandard products.

Steps to Obtain a CDSCO Manufacturing License for Oesophageal Temperature Monitor

Procuring a license requires certain pre-requisites. These include a Device Master File, Quality Management Certificate, Device Details, Site details, etc. The application process is quite straightforward and involves submission of required documents, subsequent reviews, and ultimately, approval. One may face some challenges during the licensing process, but with the right information and assistance, these challenges can be tackled efficiently.

Frequently Asked Questions (FAQs)

1. What is the risk class of the Oesophageal Temperature Monitor as per Medical Device Rules, 2017?

   The Oesophageal Temperature Monitor falls under Class B as per the Medical Device Rules, 2017.

2. What license is needed to manufacture the Oesophageal Temperature Monitor?

   An MD5 license is needed to manufacture the Oesophageal Temperature Monitor.

3. What is the fee for an MD5 license for the Oesophageal Temperature Monitor?

   The fee for an MD5 license for this device is Rs. 5,000, with a Rs. 500 fee per product.

4. Who will issue the manufacturing license for Oesophageal Temperature Monitor?

   For Class B devices like the Oesophageal Temperature Monitor, the state FDA will issue the license.

5. Is repackaging of Oesophageal Temperature Monitor considered manufacturing?

   Yes, according to the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing, and by extensions, medical devices are also drugs. Therefore, repackaging of the Oesophageal Temperature Monitor is considered manufacturing, requiring an MD5 license.

Conclusion

For more detailed information about licensing or for assistance with the process, kindly reach out to the experts at Pharmadocx Consultants, give us a call at +91-7404557227, or send an email to [email protected]. They are well equipped with knowledge and experience in successfully obtaining medical device licenses and are eager to help.