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CDSCO Manufacturing License for Invasive- detection physiological monitor

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Introduction

Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for Indian pharmaceuticals and medical devices. Being an integral part of the Ministry of Health and Family Welfare, the CDSCO is primarily responsible for safeguarding and promoting public health by assuring the quality, safety and effectiveness of drugs, cosmetics and medical devices. It has the quality mandate of regulating the manufacture, import, distribution and sales of these critical health-care products in the country.

Manufacturing licenses play a pivotal role in the medical device industry to ensure an unwavering quality standard and safety in the production process. This blog post will focus on the Invasive- detection physiological monitor, a category of neurological medical devices that have significant implications in modern healthcare. For a comprehensive understanding of the CDSCO's regulatory norms and guidelines, please visit their official portal here.

What is Invasive-detection physiological monitor?

An invasive-detection physiological monitor is a specialized medical device designed to measure, display, and/or intermittently record various invasively-detected physiological parameters, such as intracranial pressure (ICP) and compartmental pressure. These monitors are of tremendous assistance in medical procedures, particularly in the field of neurology, where the precise measurement of these parameters is critical.

The Role of CDSCO in Medical Device Regulation

The CDSCO's principle role entails establishing medical device regulations and effectively governing their implementation in the country. It routinely operates to set the bar high for medical device quality standards and ensures that these standards are adhered to strictly. CDSCO does this by laying down a stringent regulatory framework for the manufacturers, importers, and distributors of medical devices.

How to manufacture Invasive- detection physiological monitor

Manufacturing an Invasive-detection physiological monitor involves rigorous processes that adhere to the CDSCO's regulations and norms strictly. It necessitates an adherence to not only the manufacturing protocols but also an absolute compliance with the license acquisition process.

Fees for manufacturing license for Invasive-detection physiological monitor

For the manufacture of Class C devices such as the Invasive-detection physiological monitor, an MD9 license is required. The fees associated with this license are Rs. 50,000 for the license itself, along with an additional Rs. 1,000 for each product.

Why is a Manufacturing License Necessary for Invasive-detection physiological monitor?

Acquiring a manufacturing license is a mandatory prerequisite for manufacturing any medical device, including the Invasive-detection physiological monitor. This is important to ensure quality, safety, and efficacy of the final product. Compliance with the CDSCO's regulations ensures that patients and consumers are protected from substandard or unsafe products, safeguarding public health interests at large.

Steps to Obtain a CDSCO Manufacturing License for Invasive-detection physiological monitor

  1. Submission of necessary documentation like the Device Master File, Quality Management Certificate, and details about the device and the manufacturing site.
  2. A thorough review of the application by the appropriate licensing authority.
  3. Anticipate potential challenges and devise solution strategies.
  4. Final license approval upon fulfillment of all mandatory conditions.

Frequently Asked Questions (FAQs)

  1. Q: What is risk class of Invasive-detection physiological monitor as per Medical Device Rules, 2017? A: The Invasive-detection physiological monitor falls under the risk class C.

  2. Q: What license is needed to manufacture Invasive-detection physiological monitor? A: The MD9 license is required to manufacture the Invasive-detection physiological monitor.

  3. Q: What is fees for MD9 license for Invasive-detection physiological monitor? A: The MD9 license fee for manufacturing the Invasive-detection physiological monitor is Rs. 50,000 and Rs. 1,000 per individual product.

  4. Q: Who will issue manufacturing license for Invasive-detection physiological monitor? A: The CDSCO headquarters in New Delhi will issue the manufacturing license for the Invasive-detection physiological monitor.

  5. Q: Is repackaging of Invasive-detection physiological monitor considered manufacturing? A: Yes, as per the definition of manufacturing under the Drugs and Cosmetics Act, repackaging is considered as manufacturing. Accordingly, the repackaging of the Invasive-detection physiological monitor would require the MD9 license.

Conclusion

Navigating the complex regulatory landscape can be daunting, and expert help can make a huge difference. It's encouraging to reach out to the experts at Pharmadocx Consultants when in need of consultation or assistance regarding the CDSCO licensing process. Alternatively, you could reach them at +91-7404557227 or email at [email protected]. For a detailed understanding of the MD9 licensing process, check out this article here.

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