Published on

CDSCO Manufacturing License for Implantable peritoneal catheter holder

Authors
  • avatar
    Name
    CDSCO Licenses Blog
    Twitter

Introduction

The Central Drugs Standard Control Organization (CDSCO) is the principal national healthcare regulatory authority in India. It is an arm of the Ministry of Health and Family Welfare, Government of India, responsible for the regulation of pharmaceuticals, medical devices, and cosmetics to ensure the availability of safe and effective medical products to the public.

Quality manufacturing licenses are key to any medical device enterprise. These licenses ensure that production processes meet international standards which translate to high quality devices in the hands of medical practitioners, consequently improving healthcare outcomes.

The focus of this discussion is the Implantable Peritoneal Catheter Holder. This medical instrument plays a significant role in modern healthcare. For a better understanding of this subject, please visit the CDSCO's portal https://cdscomdonline.gov.in/NewMedDev/Homepage

What is Implantable Peritoneal Catheter Holder?

An implantable peritoneal catheter holder is a diminutive, sterile, surgically-installed device designed to hold a peritoneal or lumboperitoneal catheter in place by stitching it to the abdominal fascia at the catheter's entry or exit point. This device is vital in numerous medical processes such as dialysis for end-stage renal disease patients and intraperitoneal chemotherapy for effective treatment of numerous types of cancer.

The Role of CDSCO in Medical Device Regulation

The CDSCO has been regulating healthcare products in India for many years. Its mission is to safeguard public health in India by ensuring that the pharmaceuticals, medical devices, and cosmetics available to the public meet global standards of safety and efficiency. The agency achieves this by implementing robust regulatory strategies for medical devices, including an exhaustive evaluation procedure for approving new medical devices, consistent quality control and post-marketing surveillance.

How to Manufacture Implantable Peritoneal Catheter Holder

The manufacturing of the Implantable Peritoneal Catheter Holder must follow stringent health and safety norms as laid down by the CDSCO to ensure quality and reliability of the product.

Fees for Manufacturing License for Implantable Peritoneal Catheter Holder

For a Risk Class C device such as the Implantable Peritoneal Catheter Holder, an MD9 license is required. The fee for an MD9 license is Rs. 50,000 and Rs. 1,000 per product.

Why is a Manufacturing License Necessary for Implantable Peritoneal Catheter Holder?

A manufacturing license is paramount for any medical device, including the Implantable Peritoneal Catheter Holder, to maintain quality and safety in production. Regulatory compliance is a significant aspect of the healthcare sector, establishing the trust of consumers and patients by protecting them from substandard products.

Steps to Obtain a CDSCO Manufacturing License for Implantable Peritoneal Catheter Holder

Before obtaining a CDSCO manufacturing license, requisite documentation including Device Master File, Quality Management Certificate, Device Details, and Site details among others is essential. The application process involves submission of the pertinent documents to the CDSCO followed by an evaluation period, after which approval is granted, subject to successful compliance with the requisite procedures and guidelines.

Frequently Asked Questions (FAQs)

  • Q1. What is the risk class of an Implantable Peritoneal Catheter Holder as per Medical Device Rules, 2017?

    • The risk class of an Implantable Peritoneal Catheter Holder is Class C.

  • Q2. What license is needed to manufacture an Implantable Peritoneal Catheter Holder?

    • An MD9 license is required to manufacture an Implantable Peritoneal Catheter Holder.

  • Q3. What is the fee for an MD9 license for an Implantable Peritoneal Catheter Holder?

    • The fee for an MD9 license is Rs. 50,000 and Rs. 1,000 per product.

  • Q4. Who will issue the manufacturing license for Implantable Peritoneal Catheter Holder?

    • CDSCO HQ in New Delhi will issue the license.

  • Q5. Is the repackaging of an Implantable Peritoneal Catheter Holder considered manufacturing?

    • Yes, repackaging of an Implantable Peritoneal Catheter Holder is considered manufacturing and it requires an MD9 license.

For more details on the licensing procedure, kindly refer to the following article here.

Conclusion

Secure your CDSCO manufacturing license with our expert guidance at Pharmadocx Consultants. From identifying the required documents to deciphering regulatory norms, we're here to assist you in every step of your licensing journey. Visit our website at https://www.pharmadocx.com, or call us at +91-7404557227. You can also shoot us an email at [email protected] for any queries.

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