CDSCO Manufacturing License for Circulating-fluid thermal therapy system

Introduction

The Central Drugs Standard Control Organization (CDSCO) is the Central Drug Authority in India that has been charged with protecting and promoting public health. Its functions include ensuring the quality of drugs and medical devices, the approval of new drugs, conducting clinical trials, laying down standards for drugs, control of quality of imported drugs, coordination of the activities of State Drug Control Organizations and to provide expert advice to bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.

Manufacturing licenses play a pivotal role in the medical device industry. They serve as a regulatory guarantee that a medical device manufacturer adheres to stringent quality and safety standards put forth by regulatory bodies, such as the CDSCO. Today, we shed light on the Circulating-fluid thermal therapy system, a rehabilitation medical device with a significant role in treating musculoskeletal conditions resulting from injuries. Visit the CDSCO's portal to learn more about the different medical devices and the licenses required to manufacture them.

• What is a Circulating-fluid thermal therapy system?
• The Role of CDSCO in Medical Device Regulation
• How to manufacture a Circulating-fluid thermal therapy system
• Fees for manufacturing license for Circulating-fluid thermal therapy system
• Why is a Manufacturing License Necessary for Circulating-fluid thermal therapy system?
• Steps to Obtain a CDSCO Manufacturing License for Circulating-fluid thermal therapy system
• Frequently Asked Questions (FAQs)
• Conclusion

What is a Circulating-fluid thermal therapy system?

A Circulating-fluid thermal therapy system is a medical device designed to pump heated or cooled fluid such as water, through external packs applied to the body. The fluid aids in the localized treatment of adverse conditions resulting from musculoskeletal injuries. This may include conditions like inflammation, swelling, and pain. These devices play crucial roles in rehabilitation, post-surgery recovery, athletic physiotherapy and many other medically necessitated circumstances.

The Role of CDSCO in Medical Device Regulation

CDSCO has had a marked role in the regulation of medical devices in India. The organization is tasked with the mandate to safeguard and promote public health in India. This is done through the standardization and control of the quality of drugs and medical devices in the country. To ensure medical devices meet the required healthcare and patient safety standards, the CDSCO has a robust regulatory framework encompassing licensing, monitoring, and quality control practices.

How to manufacture a Circulating-fluid thermal therapy system

Coming to the production of this medical device, the manufacturing process requires adherence to the best practices and standards outlined by the CDSCO.

Fees for manufacturing license for Circulating-fluid thermal therapy system

As per the CDSCO guidelines, the Circulating-fluid thermal therapy system falls under risk Class B. Therefore, the required license is MD5. The fees for obtaining an MD5 license include the license application fee itself which is Rs. 5,000 and an additional Rs. 500 per product. For more details visit the following article.

Why is a Manufacturing License Necessary for Circulating-fluid thermal therapy system?

Obtaining a manufacturing license for any medical device, including the Circulating-fluid thermal therapy system, is a necessary legal obligation. Beyond legality though, licenses ensure the quality, safety, and compliance of the medical device production process.

The role of regulatory compliance in the healthcare sector cannot be overemphasized. It shapes the standards for products and ensures the welfare of consumers and patients. The licensing process is a rigorous one that assesses the adherence of manufacturers to these standards thereby keeping consumers and patients protected from substandard products.

Steps to Obtain a CDSCO Manufacturing License for Circulating-fluid thermal therapy system

Obtaining a CDSCO manufacturing license requires thorough preparation and understanding of the necessary pre-requisites and documentation requirements. You need to prepare documents like Device Master File, Quality Management Certificate, Device Details, Site details among others.

The application process flows from submission to approval, and it is important to be aware of potential challenges and ways to overcome them, such as correcting any identified deficiencies.

Frequently Asked Questions (FAQs)

1. Q: What is the risk class of a Circulating-fluid thermal therapy system as per Medical Device Rules, 2017?

   A: The Circulating-fluid thermal therapy system falls under risk class B.

2. Q: What license is needed to manufacture a Circulating-fluid thermal therapy system?

   A: To manufacture a Circulating-fluid thermal therapy system, an MD5 license is required.

3. Q: What is the fee for an MD5 license for a Circulating-fluid thermal therapy system?

   A: The cost of an MD5 license for a Circulating-fluid thermal therapy system is Rs.5,000 for the license and Rs.500 per product.

4. Q: Who will issue the manufacturing license for a Circulating-fluid thermal therapy system?

   A: The state FDA will issue the license for Class B devices like the Circulating-fluid thermal therapy system.

5. Q: Is repackaging of a Circulating-fluid thermal therapy system considered manufacturing?

   A: Yes, according to the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. Since the Medical Device Rules are made under the provisions of the Drug Act, repackaging of a Circulating-fluid thermal therapy system is also considered manufacturing which requires an MD5 license.

Conclusion

Navigating the CDSCO manufacturing license application can be complex. Therefore, consulting a professional can help you understand and overcome potential bottlenecks you might encounter during your application process. Pharmadocx Consultants is here to provide the necessary assistance in your journey for a CDSCO Medical Device License. You can reach out via call on "+91-7404557227" or by sending an email to "[email protected]".