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CDSCO Manufacturing License for Hollow-fibre haemodialysis dialyser

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is one of the leading regulatory bodies in the Indian medical industry. It plays a critical role in safeguarding public health by ensuring the quality, efficacy and safety of drugs and medical devices. The organization under the Ministry of Health & Family Welfare is responsible for approving licenses for the manufacture and sale of medical devices in India.

In the booming medical device industry, compliance with regulatory norms is paramount. With this in mind, all medical device manufacturers are required to obtain a CDSCO manufacturing license, according to the risk class of their medical device. These rules, as prescribed by the CDSCO, are a testament to the organization's commitment to patient safety, which is at the crux of medical care.

As the world continues to battle health crises, the significance of medical devices pertains to various fields, including nephrology and renal care. One such device in the field is the Hollow-fibre haemodialysis dialyser. A crucial medical device, its primary purpose is to filter impurities and excess fluid from a patient's blood using a haemodialysis machine.

For more information, visit CDSCO's portal here.

What is Hollow-fibre Haemodialysis Dialyser?

A Hollow-fibre Haemodialysis Dialyser is a type of medical filter used in the treatment of kidney ailments. As the name suggests, the device uses hollow fibres to filter impurities and remove surplus fluid from the patient's blood by way of a haemodialysis machine. This procedure is a typical part of treatments for patients suffering from end-stage renal disease or severe kidney dysfunction.

The Role of CDSCO in Medical Device Regulation

The CDSCO, over the years, has developed an encompassing and robust regulatory framework for medical devices in India. The organization works relentlessly to ensure the safety and efficacy of medical products in the market, thereby promoting public health. Its history is embedded with major strides in establishing regulations that protect both consumers and manufacturers alike.

How to manufacture Hollow-fibre Haemodialysis Dialyser

The manufacturing of class C medical devices, like the Hollow-fibre haemodialysis dialyser, requires stringent ethical practices, validated production processes and a deep understanding of renal care medicine and medical device manufacturing, to create a product that is safe, efficient and meets the required medical standards.

Fees for Manufacturing License for Hollow-fibre Haemodialysis Dialyser

Given that the Hollow-fibre haemodialysis dialyser is a class C medical device, as per the CDSCO risk classification, the applicable manufacturing license is MD9. The fee for an MD9 license is Rs. 50,000 and an additional Rs. 1,000 per product.

Why is a Manufacturing License Necessary for Hollow-fibre Haemodialysis Dialyser?

The manufacturing license for medical devices is compulsory and serves a greater purpose than just regulatory compliance. It ensures standardization, quality control and safety of medical devices, thereby protecting patients from substandard products. Adhering to the licensing guidelines is a mark of a manufacturer's commitment to safety and quality, significantly augmenting trust amongst consumers.

Steps to Obtain a CDSCO Manufacturing License for Hollow-fibre Haemodialysis Dialyser

Several steps are involved in obtaining a CDSCO manufacturing license. Firstly, the applicant must prepare all essential documents like a Device Master File, Quality Management Certificate, and site-specific information. Once the documents are in order, the application can be submitted for review. Upon submission, the application undergoes a rigorous review process before it is approved. Applicants must be patient and prepared for possible challenges along the way.

For more information, check out this detailed article here.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Hollow-fibre haemodialysis dialyser as per Medical Device Rules, 2017?

The risk class for Hollow-fibre haemodialysis dialyser as per the Medical Device Rules, 2017 is Class C.

Q2. What license is needed to manufacture Hollow-fibre haemodialysis dialyser?

The license needed to manufacture Hollow-fibre haemodialysis dialyser is MD9.

Q3. What is the fees for MD9 license for Hollow-fibre haemodialysis dialyser?

The fees for the MD9 license for Hollow-fibre haemodialysis dialyser is Rs. 50,000 for the license and Rs. 1,000 per product.

Q4. Who will issue manufacturing license for Hollow-fibre haemodialysis dialyser?

The manufacturing license for Hollow-fibre haemodialysis dialyser will be issued by CDSCO HQ in New Delhi.

Q5. Is repackaging of Hollow-fibre haemodialysis dialyser considered manufacturing?

Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing and by further definitions, medical devices are also drugs. Medical Device Rules have been made under the provisions of Drug Act only and hence repackaging of Hollow-fibre haemodialysis dialyser is also considered manufacturing requiring a license on MD9.

Conclusion

Navigating the complex field of medical device licensing can be challenging without the right guidance. For expert consultation or assistance regarding the licensing process, prospective manufacturers can reach out to Pharmadocx Consultants at "+91-7404557227" or email at "[email protected]". Transparent and professional, Pharmadocx aims to bridge the gap between manufacturers and the necessary compliance requirements. For more details, visit "www.pharmadocx.com".

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