Published on

CDSCO Manufacturing License for Laparoscopic grasping forceps, sterile

Authors
  • avatar
    Name
    CDSCO Licenses Blog
    Twitter

Introduction

The Central Drugs Standard Control Organization (CDSCO) is one of the most important organizations in India's medical industry. It sets the standards and guidelines that control the safety, efficacy, and quality of drugs, cosmetics, diagnostics, and medical devices in India. In the medical device industry, obtaining manufacturing licenses is imperative for legal manufacturing and selling products.

In this blog post, we will be discussing the CDSCO manufacturing license for Laparoscopic Grasping Forceps. The significance of this tool in medical procedures is immense as they are designed for grasping and manipulating tissues during laparoscopic surgical procedures. For further information related to medical devices, you can visit CDSCO's portal

What is Laparoscopic Grasping Forceps?

Laparoscopic Grasping Forceps is a rigid surgical instrument that is used for grasping and manipulating tissues during laparoscopic surgical procedures. It is typically used in gastroenterology, aiding surgeons perform complex procedures with ease and precision.

Role of CDSCO in Medical Device Regulation

CDSCO's mission is focused on safeguarding and promoting public health. CDSCO is responsible for setting up the framework for medical devices, ensuring that they are safe and efficient for use.

How to Manufacture Laparoscopic Grasping Forceps

For manufacturing Laparoscopic Grasping Forceps, manufacturers need to adhere to the guidelines and standards set by CDSCO and other relevant bodies. High standards of quality, safety, and efficacy are non-negotiable in the manufacturing process.

Fees for Manufacturing License for Laparoscopic Grasping Forceps

As Laparoscopic Grasping Forceps fall under risk Class B, an MD-5 license is required for manufacturing. The fee for an MD-5 license is Rs 5,000 for the license and Rs. 500 per product. For more detailed information, you can refer to this article - MD-5 License

Why is a Manufacturing License Necessary for Laparoscopic Grasping Forceps

A manufacturing license is paramount for following reasons:

  • To legally manufacture and sell a medical device.
  • Ensuring the production of quality medical devices in standardised conditions.
  • To ensure regulatory compliance in the healthcare sector.
  • Protecting consumers and patients from substandard and unsafe products.

Steps to Obtain a CDSCO Manufacturing License for Laparoscopic Grasping Forceps

The steps to obtain a manufacturing license are as follows:

  • First and foremost, fulfil all prerequisites and documentation including Device Master File, Quality Management Certificate, Device Details, Site details etc.
  • Follow the application process from submission to approval as outlined by CDSCO.
  • Tackle common challenges that might come up in the process with careful planning and foresight.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Laparoscopic Grasping Forceps as per Medical Device Rules, 2017?

A1. The risk class for Laparoscopic Grasping Forceps as per Medical Device Rules, 2017 is Class B.

Q2. What license is needed to manufacture Laparoscopic Grasping Forceps?

A2. To manufacture Laparoscopic Grasping Forceps, an MD5 license is needed.

Q3. What is the fees for MD5 license for Laparoscopic Grasping Forceps?

A3. The fee for an MD-5 license for Laparoscopic Grasping Forceps is Rs. 5000 for the license and Rs. 500 per product.

Q4. Who will issue the manufacturing license for Laparoscopic Grasping Forceps?

A4. For Class B devices, which include Laparoscopic Grasping Forceps, the state FDA will issue the license.

Q5. Is repackaging of Laparoscopic Grasping Forceps considered manufacturing?

A5. Yes, as per the 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 Laparoscopic Grasping Forceps is also considered manufacturing requiring an MD5 license.

Conclusion

To ensure that your application for a manufacturing license for Laparoscopic Grasping Forceps is successful, it is essential to have all the necessary documentation ready and be prepared for the challenges that might come up in the process.
Pharmadocx Consultants can provide you with expert assistance to navigate through the process. You can reach out to them for consultation or assistance at "Pharmadocx'' or call on "+91-7404557227" or email them at ''[email protected]''.

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