Published on

CDSCO Manufacturing License for Collagen-containing peritoneum absorbable catheter cuff

Authors
  • avatar
    Name
    CDSCO Licenses Blog
    Twitter

Introduction

The Central Drugs Standard Control Organization (CDSCO) is a vital part of India's healthcare system, responsible for ensuring the safety, efficacy, and quality of the drugs, cosmetics and medical devices available to the general public. It is the pinnacle regulatory authority in India, responsible for controlling the quality of pharmaceuticals and medical devices in the country. An essential aspect of this control is the granting of manufacturing licenses for medical devices, which helps maintain a high standard of quality and security for users of these devices in medical procedures.

One such device that plays a significant role in nephrology is the Collagen-containing peritoneum absorbable catheter cuff. This medical device holds critical importance in renal care procedures, extensively utilized in peritoneal dialysis procedures. For more information, visit CDSCO's portal here

What is Collagen-containing peritoneum absorbable catheter cuff?

A collagen-containing peritoneum absorbable catheter cuff is a cuff made of biodegradable porous material containing collagen. The primary purpose of this device is to be embedded subcutaneously at the outlet of a peritoneal dialysis catheter. It plays a crucial role in many procedures, particularly those involving peritoneal dialysis and nephrology.

The Role of CDSCO in Medical Device Regulation

The CDSCO plays a significant role in regulating medical devices in India. Its mission is to ensure the safety, quality, and effectiveness of medical devices available for use in the healthcare industry. CDSCO's regulatory framework for medical devices includes a stringent licensing process that involves a comprehensive overview of the device's efficacy, safety, and quality.

How to manufacture Collagen-containing peritoneum absorbable catheter cuff

The manufacturing process for this device involves the creation of a cuff using biodegradable material and collagen. This cuff is then designed to be easily embedded under the skin at the outlet of a peritoneal dialysis catheter. Making sure the device meets high-quality standards is critical, and the manufacturing process is closely monitored to maintain these standards.

Fees for manufacturing license for Collagen-containing peritoneum absorbable catheter cuff

The fees for a manufacturing license for a Class D device like Collagen-containing peritoneum absorbable catheter cuff is Rs. 50,000 for the license and Rs. 1,000 per product under the MD9 license category.

Why is a Manufacturing License Necessary for Collagen-containing peritoneum absorbable catheter cuff?

Obtaining a manufacturing license is mandatory for producing Collagen-containing peritoneum absorbable catheter cuffs. This ensures quality control over the production of medical devices. Regulatory compliance in healthcare is crucial for maintaining the safety and effectiveness of medical products. It also protects consumers and patients from substandard products and ensures they receive only high-quality, safe, and effective devices.

Steps to Obtain a CDSCO Manufacturing License for Collagen-containing peritoneum absorbable catheter cuff

The licensing process requires several prerequisites and documents such as Device Master File, Quality Management Certificate, Device Details, and Site details. The application process involves submission of required documents and awaits approval. Common challenges involve meeting stringent regulations and ensuring high-quality standards, which could be overcome by hiring a good consultancy service. For a detailed step-by-step procedure on obtaining an MD9 license visit this link

Frequently Asked Questions (FAQs)

  • Q1: What is risk class of Collagen-containing peritoneum absorbable catheter cuff as per Medical Device Rules, 2017? The risk class for Collagen-containing peritoneum absorbable catheter cuff is Class D.

  • Q2: What license is needed to manufacture Collagen-containing peritoneum absorbable catheter cuff? MD9 license is required to manufacture Collagen-containing peritoneum absorbable catheter cuff.

  • Q3: What is fees for MD9 license for Collagen-containing peritoneum absorbable catheter cuff? The fees for MD9 license is Rs. 50,000 for the license and Rs. 1,000 per product

  • Q4: Who will issue manufacturing license for Collagen-containing peritoneum absorbable catheter cuff? The CDSCO HQ in New Delhi will issue the license for Class D devices like Collagen-containing peritoneum absorbable catheter cuff.

  • Q5: Is repackaging of Collagen-containing peritoneum absorbable catheter cuff 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 Collagen-containing peritoneum absorbable catheter cuff is also considered manufacturing requiring an MD9 license.

Conclusion

Navigating the maze of manufacturing licenses and regulations can be daunting, but you don't have to do it alone. Reach out to Pharmadocx Consultants for consultation or assistance regarding the licensing process. If you prefer, you can simply call at +91-7404557227 or email [email protected] for more information. Your success in obtaining the necessary manufacturing license is just a phone call or email away!

cdsco import license in india banner
cdsco manufacturing license in india banner