CDSCO Manufacturing License for Sterile Surgical file

Introduction

The Central Drugs Standard Control Organization (CDSCO) is a prominent agency in India that ensures the safety, efficacy, and quality of medicines and medical devices. Its key responsibilities include regulating the manufacture, sale, and distribution of drugs and medical devices, conducting surveys for establishing drug standards and testing imported and exported drugs and medical devices.

In the medical device industry, obtaining a manufacturing license is of utmost importance, as it signifies compliance with the CDSCO’s regulatory standards, ensuring public safety and health. This licensing ensures that only the highest quality medical devices reach the end consumers, thus protecting them from subpar and unsafe products.

Today, we’ll delve into understanding a pivotal device used in numerous medical procedures: the Sterile Surgical File. We'll explore its significance, the role of CDSCO in its regulation, and the requirements for manufacturing it in India.

For further information, you can always visit the CDSCO's official portal - CDSCO Online

• What is a Sterile Surgical File?
• The Role of CDSCO in Medical Device Regulation
• How to manufacture a Sterile Surgical File
• Fees for manufacturing license for a Sterile Surgical File
• Why is a Manufacturing License Necessary for a Sterile Surgical File?
• Steps to Obtain a CDSCO Manufacturing License for a Sterile Surgical File
• Frequently Asked Questions (FAQs)
• Conclusion

What is a Sterile Surgical File?

A Sterile Surgical File is a manually operated, hand-held surgical instrument designed for use during surgical procedures. It is typically equipped with a series of bumps or teeth on its surface and is used to smoothen out, grind off or sever tissues.

Commonly used in an Operation Theatre, a Sterile Surgical File is critical for reshaping or removing dense tissues, aligning bone fragments, and performing intricate surgical procedures.

The Role of CDSCO in Medical Device Regulation

The CDSCO, as the national regulatory body for medical devices, plays a pivotal role in ensuring public health and safety. Its mission is to protect and promote public health by ensuring the safety, efficacy, and quality of medical devices.

The CDSCO achieves this through a comprehensive regulatory framework, involving meticulous evaluation, licensing, and post-marketing surveillance of medical devices.

How to manufacture a Sterile Surgical File

Manufacture of a Sterile Surgical File, like any Class B medical device, requires thorough knowledge of the device, its intended use, the materials used, and strict adherence to manufacturing guidelines delineated by the CDSCO.

Fees for manufacturing license for a Sterile Surgical File

Given that a Sterile Surgical File is a Class B medical device, the license required is MD5. The fee for obtaining this license is Rs. 5,000 with an additional Rs. 500 per product.

Why is a Manufacturing License Necessary for a Sterile Surgical File?

Obtaining a manufacturing license is mandatory for several reasons. Firstly, it ensures quality and safety in medical device production, which is integral to maintaining public health. Furthermore, regulatory compliance significantly minimizes the proliferation of substandard products, providing consumers and patients with safe and effective medical devices.

Steps to Obtain a CDSCO Manufacturing License for a Sterile Surgical File

1. Submit necessary documentation (Device Master File, Quality Management Certificate, Device Details, Site details, etc.).
2. Fulfill relevant prerequisites outlined by the CDSCO.
3. Go through an application process: from submission to approval.
4. Overcome common challenges with expert advice and professional support.

More information on the MD5 manufacturing license can be found in this article - MD5 License

Frequently Asked Questions (FAQs)

Q.1 What is the risk class of a Sterile Surgical File as per Medical Device Rules, 2017?

A.1 The risk class of a Sterile Surgical File as per Medical Device Rules, 2017 is Class B.

Q.2 What license is needed to manufacture a Sterile Surgical File?

A.2 The license needed to manufacture a Sterile Surgical File is MD5.

Q.3 What is the fee for the MD5 license for a Sterile Surgical File?

A.3 The fee for the MD5 license for a Sterile Surgical File is Rs. 5,000, plus Rs. 500 per product.

Q.4 Who will issue the manufacturing license for a Sterile Surgical File?

A.4 For Class B devices like the Sterile Surgical File, the state FDA will issue the license.

Q.5 Is the repackaging of a Sterile Surgical File considered manufacturing?

A.5 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. Therefore, repackaging of a Sterile Surgical File is also considered manufacturing requiring an MD5 license.

Conclusion

Navigating the licensing process can be complex and overwhelming, especially when ensuring compliance with regulations and addressing potential hurdles. However, you are not alone in this journey.

Pharmadocx Consultants provides expert advice and professional support to help you effortlessly navigate this process. Feel free to reach out for consultation or assistance regarding the licensing process at Pharmadocx Consultants, or call us at "+91-7404557227". Alternatively, you can drop us an email at [email protected]

The objective of following the licensure protocol, right from licensing prerequisites to conquering common challenges, is to uphold superior standards of quality and reliability of life-saving medical devices. Thus, safeguarding public health and welfare.