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CDSCO Manufacturing License for Citric acid haemodialysis system cleaning cartridge

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Introduction

Welcome to the complex and highly regulated world of medical device manufacturing in India. The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory authority for pharmaceuticals and medical devices. Manufacturing licenses are an essential part of the medical device industry, forming a crucial cog in ensuring that only high-quality, safe, and effective devices reach patients.

Today, we will be discussing the manufacturing process and requirements for the "Citric Acid Haemodialysis System Cleaning Cartridge," a Class B medical device under CDSCO regulations. This article serves to enlighten you on the importance of the device and guide you on the path to obtaining a manufacturing license from CDSCO. Here is a link to CDSCO's portal for more official information - CDSCO Portal.

What is A Citric Acid Haemodialysis System Cleaning Cartridge?

The Citric Acid Haemodialysis System Cleaning Cartridge, as the term suggests, is a key component in cleaning and maintaining haemodialysis systems. It is designed for the in-line preparation of a citric acid solution, which is used to clean/disinfect the fluid pathways of the system and remove calcium and magnesium deposits in conjunction with a heat disinfection program.

The Role of CDSCO in Medical Device Regulation

Formed over 70 years ago, the CDSCO oversees the safety, efficacy, and quality of drugs and medical devices in India. It operates under the Ministry of Health & Family Welfare, acting as India's central authority for pharmaceuticals and medical devices. The CDSCO's regulatory framework for medical devices comprises various aspects such as classification, clinical trials, and licensing.

How to manufacture Citric Acid Haemodialysis System Cleaning Cartridge

Manufacturing the Citric Acid Haemodialysis System Cleaning Cartridge requires strict adherence to CDSCO's regulations.

Fees for manufacturing license for Citric Acid Haemodialysis System Cleaning Cartridge

Given that the Citric Acid Haemodialysis System Cleaning Cartridge is a Class B device, a MD5 license will be required. The fee for the MD5 license is Rs. 5,000, and there is an additional cost of Rs. 500 per product.

Why is a Manufacturing License Necessary for Citric Acid Haemodialysis System Cleaning Cartridge?

Manufacturing licenses are obligatory for the production of any medical device in India. These licences ensure the production of high-quality and safe medical devices, maintain regulatory compliance in the healthcare sector, and protect consumers and patients from inferior quality products.

Steps to Obtain a CDSCO Manufacturing License for Citric Acid Haemodialysis System Cleaning Cartridge

  1. Ensuring requisite documentation, including the Device Master File, Quality Management Certificate, Device Details, Site details, etc.
  2. Application submission to the respective authority.
  3. Await license approval.
  4. Navigating any challenges that arise during the application process.

NOTE: You can find further details regarding the MD5 License procedure here.

Frequently Asked Questions (FAQs)

  • Q1. What is the risk class of Citric Acid Haemodialysis System Cleaning Cartridge as per Medical Device Rules, 2017?

    The risk class of Citric Acid Haemodialysis System Cleaning Cartridge is Class B.

  • Q2. What license is needed to manufacture Citric Acid Haemodialysis System Cleaning Cartridge?

    To manufacture a Citric Acid Haemodialysis System Cleaning Cartridge, an MD5 license is required.

  • Q3. What is the fee for the MD5 license for Citric Acid Haemodialysis System Cleaning Cartridge?

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

  • Q4. Who will issue the manufacturing license for Citric Acid Haemodialysis System Cleaning Cartridge?

    For a Class B device like the Citric Acid Haemodialysis System Cleaning Cartridge, the state FDA will issue the license.

  • Q5. Is repackaging of Citric Acid Haemodialysis System Cleaning Cartridge considered manufacturing?

    Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing and the same applies to medical devices as well. By such definitions, repackaging of Citric Acid Haemodialysis System Cleaning Cartridge is indeed considered manufacturing, requiring an MD5 license.

Conclusion

Embarking on the journey of manufacturing any medical device can be challenging, but it is a rewarding experience. Navigating through the regulations and licensing processes is not always easy, and having expert guidance can be beneficial. For consultation or assistance regarding the licensing process, you can reach out to Pharmadocx Consultants or call on +91-7404557227 or email at [email protected]. They will be more than happy to guide you through the labyrinth of regulatory procedures!

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