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CDSCO Manufacturing License for Hydrogen Peroxide Gas Plasma Sterilization System

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory authority for drugs and medical devices. Its primary responsibility entails ensuring the safety, efficacy, and quality of drugs, cosmetics, diagnostics, and devices in the country. With a portfolio that spans the approval of new drugs, clinical trials, import licenses, to the inspection of manufacturing facilities, CDSCO regulates a vast and dynamic healthcare field.

In this landscape, the importance of manufacturing licenses for medical devices like the Hydrogen Peroxide Gas Plasma Sterilization System cannot be understated. The license ensures standardization in product quality, processes, and safety. Licenses are a measure of quality assurance that medical device manufacturers must comply with to protect patient safety.

The Hydrogen Peroxide Gas Plasma Sterilization System is a medical device of immense importance. Its role in ensuring sterile conditions for both metal and polymer based medical instruments plays a crucial part in preventing infection and promoting patient safety.

To learn more about the regulations and processes, visit the CDSCO's portal.

What is a Hydrogen Peroxide Gas Plasma Sterilization System?

In brief, a Hydrogen Peroxide Gas Plasma Sterilization System is a medical device used for sterilizing and disinfecting medical instruments. Through the deposition of plasma, it ensures that both metal and non-metal/polymer-based medical devices are free from any kind of microbial contamination.

The system finds its application often in the general hospital and orthopedic sectors where sterile instruments play a key role in surgery and patient care.

The Role of CDSCO in Medical Device Regulation

Established as India's prime authority in regulating drugs and devices, CDSCO's mission revolves around safeguarding public health by ensuring safe, effective, and quality medical products.

For medical devices, CDSCO adopts a risk-based approach through which it assigns different risk classes - A, B, C, and D to different devices. A regulatory framework is set in place to ensure medical devices manufactured or imported conform to specified requirements.

How to manufacture a Hydrogen Peroxide Gas Plasma Sterilization System

The manufacturing process is subject to stringent regulatory checks to assure quality and safety. Each step, from fabrication, packaging to storing, is conducted under regulated conditions to prevent potential contamination.

Fees for manufacturing license for Hydrogen Peroxide Gas Plasma Sterilization System

The fees for getting a manufacturing license for a Class C medical device is initially Rs. 50,000 for an MD9 license. Further, an additional fee of Rs. 1,000 per product is also required.

Why is a Manufacturing License Necessary for Hydrogen Peroxide Gas Plasma Sterilization System?

Acquiring a manufacturing license is not merely a formality. It is a mandatory requirement, primarily established to monitor and regulate the production processes, hence ensuring quality and safety. Compliance with the regulation also prevents the proliferation of sub-standard products that could pose health risks.

Steps to Obtain a CDSCO Manufacturing License for Hydrogen Peroxide Gas Plasma Sterilization System

Obtaining a CDSCO manufacturing license involves a few key processes. Only after providing a comprehensive Device Master File, a Quality Management Certificate, and detailed site specifications can an application be considered. The application process often unfolds in the following steps:

  1. Application Submission
  2. Assessment of the application
  3. Inspection of Manufacturing Sites
  4. Approval/Rejection

Despite being a straightforward process, it can present challenges. To know more about the MD9 license for Class C medical devices, visit this article.

Frequently Asked Questions (FAQs)

  1. What is the risk class of Hydrogen Peroxide Gas Plasma Sterilization System as per Medical Device Rules, 2017? The risk class for Hydrogen Peroxide Gas Plasma Sterilization System is Class C.

  2. What license is needed to manufacture Hydrogen Peroxide Gas Plasma Sterilization System? An MD9 license is required to manufacture Hydrogen Peroxide Gas Plasma Sterilization System.

  3. What is the fee for an MD9 license for Hydrogen Peroxide Gas Plasma Sterilization System? The fee for an MD9 license is Rs. 50,000, and there is an additional fee of Rs. 1,000 per product.

  4. Who will issue a manufacturing license for Hydrogen Peroxide Gas Plasma Sterilization System? The manufacturing license for Class C medical devices like the Hydrogen Peroxide Gas Plasma Sterilization System will be issued by the CDSCO HQ in New Delhi.

  5. Is repackaging of Hydrogen Peroxide Gas Plasma Sterilization System considered manufacturing? Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. By extension, medical devices are also drugs. Therefore, repackaging of Hydrogen Peroxide Gas Plasma Sterilization System requires an MD9 license.

Conclusion

Securing a CDSCO manufacturing license is an imperative but often challenging step for medical device manufacturers. The stringent norms, extensive documentation, and due diligence necessitate professional assistance.

Pharmadocx Consultants can provide this much-needed guidance and support. For consultation or assistance regarding the licensing process, reach out to Pharmadocx Consultants or call directly at +91-7404557227. Inquiries can also be emailed to [email protected].

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