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CDSCO Manufacturing License for Single Needle Hemodialysis Catheter/ Blood lines

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Introduction

Central Drugs Standard Control Organization (CDSCO) is the prime pharmaceutical and medical device regulatory authority in India. It is primarily charged with the responsibility of standardizing and regulating the safety, efficacy and quality of individual and collective healthcare products. Manufacturing licenses, are a crucial part of the medical device industry. These licenses establish a minimum bar of quality assurance and legal compliance that manufacturers must meet to ensure patient safety.

We are going to discuss the Single Needle Hemodialysis Catheter, a critical device in the realm of Nephrology and Renal Care. The catheter is used for single-needle dialysis, a procedure where only one cannula or a single lumen catheter is used to access the blood.

To obtain a comprehensive and authentic database on manufacturing and import licenses for medical devices, refer to CDSCO's portal here.

What is Single Needle Hemodialysis Catheter?

A Single Needle Hemodialysis Catheter or Blood lines, in medical parlance, is a device designed for single-needle dialysis. This is performed when only one cannula or a one lumen catheter is employed to access blood. The device is most commonly used for patients requiring dialysis, more specifically during Hemodialysis - a procedure that purifies the blood of a person whose kidneys aren't working normally.

The Role of CDSCO in Medical Device Regulation

Established under the Drugs and Cosmetics Act, CDSCO has been the beacon of pharmaceutical and medical device regulation in India. The agency's regulatory framework for medical devices includes a risk-based scoring system which determines the category and licensing fees for each device.

How to Manufacture Single Needle Hemodialysis Catheter

Manufacturing the Single Needle Hemodialysis Catheter requires adherence to standard procedures, production protocols, and production quality assurance. More importantly, manufacturers must also obtain an appropriate Class B MD5 manufacturing license, as stipulated by CDSCO.

Fees for Manufacturing License for Single Needle Hemodialysis Catheter

For the manufacturing of Single Needle Hemodialysis Catheters under risk class B, the necessary license is MD5. The fees are Rs. 5,000 for the license and an additional Rs. 500 per product.

Why is a Manufacturing License Necessary for Single Needle Hemodialysis Catheter?

A manufacturing license is paramount to ensure quality and patient safety. Medical devices, such as the Single Needle Hemodialysis Catheter, play a vital role in healthcare, and therefore, ensuring their quality is non-negotiable. Regulatory compliance in the healthcare sector means manufacturers produce products that meet or exceed industry standards, further protecting consumers and patients from substandard products.

Steps to Obtain a CDSCO Manufacturing License for Single Needle Hemodialysis Catheter

Documents that require submission consist of the Device Master File, Quality Management Certificate, Device Details, Site details, among others. The four primary steps are: submitting the application form, paying requisite fees, awaiting approval from the regulatory body, and finally, obtaining the license. Challenges that may arise during this process can include paperwork errors and application rejection. It is essential always to ensure accuracy and completion when submitting the necessary documents.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Single Needle Hemodialysis Catheter as per Medical Device Rules, 2017?

Class B

Q2. What license is needed to manufacture Single Needle Hemodialysis Catheter?

MD5 License is required

Q3. What is the fee for an MD5 license for Single Needle Hemodialysis Catheter?

Rs. 5,000 for the license and Rs. 500 per product

Q4. Who will issue the manufacturing license for Single Needle Hemodialysis Catheter?

For Class A sterile and measuring & Class B devices - state FDA will issue license

Q5. Is repackaging of Single Needle Hemodialysis Catheter 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 Single Needle Hemodialysis Catheter is also considered manufacturing requiring an MD5 license.

Conclusion

It is never easy to navigate through regulatory licensing processes without expert guidance. For assistance in understanding and applying for the right CDSCO manufacturing license for devices like the Single Needle Hemodialysis Catheter, reach out to the expert consultation of Pharmadocx Consultants. You can reach them through their website "https://www.pharmadocx.com", or call on "+91-7404557227" or drop an email at "[email protected]".

For more detailed information on MD5 license required for manufacturing class A sterile, measuring & class B medical devices, feel free to read this article.

Navigating through licensing procedures is easier when you have experts on your side. Turn your focus on manufacturing top-quality medical devices and let us take over the licensing hurdles.

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