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CDSCO Manufacturing License for Liquid chemical sterilants/high level disinfectants.

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Introduction

CDSCO (Central Drugs Standard Control Organization) is India's premier national regulatory body for Indian pharmaceuticals and medical devices. It ensures that drugs and medical devices manufactured and sold in India are safe, effective, and fulfil the intended benefits as claimed by their respective manufacturers. A significant part of CDSCO's responsibility involves issuing manufacturing licenses for medical devices such as the Liquid Chemical Sterilants/High Level Disinfectants.

Medical device manufacturing licenses play a pivotal role in the medical device industry. They are a testament to a product's safety, efficacy, and compliance with health and quality regulations. In particular, for a critical medical device like Liquid Chemical Sterilants/High Level Disinfectants, which plays a major role in ensuring the sterilization and disinfection of surgical and orthopaedic tools, acquiring a manufacturing license from CDSCO is essential. To learn more, you can access more information from CDSCO's portal here.

What is Liquid Chemical Sterilants/High Level Disinfectants?

This is a type of germicide specifically designed as the terminal step in processing critical and semicritical medical devices before they are used on patients. The high-level disinfectants play an integral role in the elimination of microbial presence, ensuring that the medical devices used during surgeries or treatment procedures are free from harmful micro-organisms.

Common uses of Liquid Chemical Sterilants/High Level Disinfectants include sterilizing surgical instruments and orthopaedic tools. They help maintain a sterile environment, reducing the risk of infection during medical procedures.

The Role of CDSCO in Medical Device Regulation

CDSCO's main objective revolves around maintaining and promoting public health in India. They achieve this by ensuring the safety, efficacy and quality of drugs, cosmetics and medical devices available to the Indian public.

An integral part of CDSCO's operations includes the regulation of medical devices — a comprehensive process that involves risk classification, product evaluation, and issuance of manufacturing licenses.

How to manufacture Liquid Chemical Sterilants/High Level Disinfectants

Manufacturing such a critical product involves stringent quality control measures and compliance with best practices. More so because it falls under Risk Class C as per the Medical Device Rules, 2017.

Fees for manufacturing license for Liquid Chemical Sterilants/High Level Disinfectants

For manufacturing of Risk class C medical devices, an MD9 license is required. The fee for MD9 is Rs. 50,000 for the license and Rs. 1,000 per product. More details about it can be found here.

Why is a Manufacturing License Necessary for Liquid Chemical Sterilants/High Level Disinfectants?

Mandatory by law, a manufacturing license guarantees that your product complies with safety and quality standards. It also ensures the consistent production quality, protects patients and consumers from substandard products, and promotes regulatory compliance in the healthcare sector.

Steps to Obtain a CDSCO Manufacturing License for Liquid Chemical Sterilants/High Level Disinfectants

The licensing process involves preparing the prerequisite documentation, which includes the Device Master File, Quality Management Certificate, Device Details, site details, etc. It proceeds to the application submission, review and eventual approval. The process might present common challenges, but these can be identified and overcome with appropriate strategies and resources.

Frequently Asked Questions (FAQs)

Q. What is the risk class of Liquid Chemical Sterilants/High Level Disinfectants as per Medical Device Rules, 2017?

A. The risk class of Liquid Chemical Sterilants/High Level Disinfectants as per Medical Device Rules, 2017, is Risk Class C.

Q. What license is needed to manufacture Liquid Chemical Sterilants/High Level Disinfectants?

A. To manufacture Liquid Chemical Sterilants/High Level Disinfectants, an MD9 license is required.

Q. What is the fees for MD9 license for Liquid Chemical Sterilants/High Level Disinfectants?

A. The fee for MD9 is Rs. 50,000 for the license and Rs. 1,000 per product.

Q. Who will issue the manufacturing license for Liquid Chemical Sterilants/High Level Disinfectants?

A. For Risk Class C devices such as Liquid Chemical Sterilants/High Level Disinfectants, the CDSCO HQ in New Delhi will issue the license.

Q. Is repackaging of Liquid Chemical Sterilants/High Level Disinfectants considered manufacturing?

A. Yes. The Drugs and Cosmetics Act's definition of manufacturing includes repackaging, making it necessary for repackaging of Liquid Chemical Sterilants/High Level Disinfectants to have an MD9 license.

Conclusion

If you need further clarification or consultation regarding the licensing process, feel free to reach out to Pharmadocx Consultants via their website, call them on 7404557227, or send an email to [email protected]. You can also read more about the MD9 license and MD5 license on their website. Your legal compliance and product safety are our prior concerns.

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