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CDSCO Manufacturing License for Absorbable peritoneum catheter cuff

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Introduction

Central Drugs Standard Control Organization (CDSCO) is India's main regulatory body for ensuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices. CDSCO plays an essential role in safeguarding public health by overseeing the quality of drugs and medical products in India. They are entrusted with the responsibility of approving new medical devices, laying down the standards, and regulating the market to ensure high-quality medical products. Manufacturing licenses issued by CDSCO are a foundational part of the medical device industry, helping ensure that the products that enter the marketplace are safe and effective.

In today's discussion, our focus lies on a very significant and special medical device - the Absorbable peritoneum catheter cuff. This medical device serves a critical role in the field of nephrology, specifically, renal care. For more in-depth information and access to various medical devices data, you can visit CDSCO's portal here.

What is an Absorbable peritoneum catheter cuff?

An Absorbable peritoneum catheter cuff is a medical device intended to maintain stable contact between the skin and the peritoneal dialysis catheter. It prevents bacterial invasion from the outlet and is embedded subcutaneously at the outlet of the peritoneal dialysis catheter. This device plays an integral role in peritoneal dialysis procedures, a treatment for patients with severe chronic kidney disease.

The Role of CDSCO in Medical Device Regulation

Since its establishment, CDSCO has been spearheading the regulatory framework in India for drugs, cosmetics, and medical devices. Its mission is to safeguard and enhance public health by ensuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices. CDSCO oversees the implementation of standards and guidelines for the production, quality control, and distribution of these products, including the Absorbable peritoneum catheter cuff.

How to manufacture an Absorbable peritoneum catheter cuff

Manufacturing the Absorbable peritoneum catheter cuff requires adherence to a rigorous set of guidelines and regulations, as laid out by CDSCO. Especially since it falls under Risk class D, the highest risk class, there is a high standard for quality control and safety measures.

Fees for manufacturing license for an Absorbable peritoneum catheter cuff

Given the device is under risk class D, the applicable license is MD9. The fees for MD9 are Rs. 50,000 for license and Rs. 1,000 per product. More details can be found here.

Why is a Manufacturing License Necessary for an Absorbable peritoneum catheter cuff?

Obtaining a manufacturing license is mandatory for all medical devices; the Absorbable peritoneum catheter cuff is no exception. The license is critical to ensure the device produced is the best possible quality to ensure safety in medical device production. Moreover, the manufacturing license also signifies regulatory compliance with the healthcare sector's laws and guidelines. A key part of regulatory compliance is to protect consumers and patients from substandard or inferior products.

Steps to Obtain a CDSCO Manufacturing License for an Absorbable peritoneum catheter cuff

  1. Prepare necessary pre-requisites and documentation required such as Device Master File, Quality Management Certificate, Device Details, Site details, etc.
  2. Submit your application to the relevant authorities.
  3. Await the review process, during which your documentation, compliance with standards and other requirements will be assessed.
  4. Once your application has been approved, meet the requisite duties and obtain your license.

Frequently Asked Questions (FAQs)

  • Q1. What is the risk class of an Absorbable peritoneum catheter cuff as per Medical Device Rules, 2017? The Absorbable peritoneum catheter cuff comes under risk class D as per Medical Device Rules, 2017.

  • Q2. What license is needed to manufacture an Absorbable peritoneum catheter cuff? Since this device falls under risk class D, a MD9 license is required for its manufacturing.

  • Q3. What is the fee for an MD9 license for an Absorbable peritoneum catheter cuff? The fees for an MD9 license are Rs. 50,000 for the license and Rs. 1,000 per product.

  • Q4. Who will issue the manufacturing license for an Absorbable peritoneum catheter cuff? For Class D devices such as this, the license will be issued by the CDSCO HQ in New Delhi.

  • Q5. Is repackaging of an Absorbable peritoneum catheter cuff considered manufacturing? Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. By further definitions, medical devices are also drugs. Therefore, repackaging of an Absorbable peritoneum catheter cuff is also considered manufacturing and requires an MD9 license.

Conclusion

Navigating the licensing process can be a daunting task. Don't hesitate to reach out for consultation or assistance regarding the licensing process to Pharmadocx Consultants. You can give us a call at +91-7404557227 or drop an email at [email protected]. Our team of experts is always ready to assist you with your needs. As your partners in the journey of medical device manufacturing, we are committed to empowering your success.

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