CDSCO Manufacturing License for Shaver System

Introduction

CDSCO (Central Drugs Standard Control Organization) is at the helm of India's pharmaceutical and medical device regulation, diligently upholding standards and regulations to ensure the safety and efficacy of pharmaceuticals and medical devices available within the country. One of its main functions is to regulate the manufacture of these products through licenses, ensuring quality and compliance with internationally acknowledged standards.

In the sphere of medical devices, a manufacturing license plays a pivotal role. It acts as a clearance and a standard of quality, assuring that the product is trustworthy and safe for its intended use. One such useful medical device is the Shaver System.

The Shaver System is a surgical device intended for the resection of soft and osseous tissues during a surgical procedure. Burgeoning developments in surgical techniques and the need for accurate, safe instruments underscore the importance of manufacturing regulation for such devices. More information on the CDSCO and its roles can be found on their CDSCO's portal.

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

What is Shaver System?

The Shaver System is a surgical tool, designed for the cutting, abrading, and removing of hard or soft tissues during surgical procedures. It offers precision and control to surgeons across a variety of procedures, from arthroscopic to orthopedic surgeries.

The Role of CDSCO in Medical Device Regulation

The CDSCO has been entailed with the task of ensuring the safety and quality of medical devices within India. Through its regulatory framework, it oversees the manufacturing, import, sale, and distribution of medical devices, prescribing stringent standards for each cross-section of the medical device sector.

How to manufacture Shaver System

The manufacture of the Shaver System, categorized under Class B devices, requires compliance with specific quality guidelines and procedures. It necessitates a controlled, sterile environment and stringent manufacturing processes.

Fees for manufacturing license for Shaver System

The manufacturing license for Class B devices under which the Shaver System falls, is MD5. The fee for the MD5 license is Rs. 5,000 for the license and Rs. 500 per product.

Why is a Manufacturing License Necessary for Shaver System?

Obtaining a manufacturing license is mandatory according to the Drugs and Cosmetics Act. It substantiates the quality and safety of the medical device being produced and protects patients from substandard products. Furthermore, compliance with regulatory standards lends credibility and builds trust among consumers.

Steps to Obtain a CDSCO Manufacturing License for Shaver System

Prepare required documents, including Device Master File, Quality Management Certificate, Device Details, Site details etc.
Submit an application for the license.
Wait for the review process by the CDSCO.
Upon approval, proceed with the manufacturing process.
For a detailed procedure, refer to this article.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Shaver System as per Medical Device Rules, 2017? A. The Shaver System falls under Risk Class B.

Q2. What license is needed to manufacture Shaver System? A. To manufacture Shaver System, an MD5 license is required.

Q3. What is the fee for an MD5 license for Shaver System? A. The fee for an MD5 license is Rs. 5,000 for the license and Rs. 500 per product.

Q4. Who will issue the manufacturing license for Shaver System? A. For Class B devices like the Shaver System, the state FDA will issue the license.

Q5. Is the re-packaging of Shaver System considered manufacturing? A. Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, re-packaging of drugs is considered manufacturing. As the Shaver System falls under medical device regulations, its re-packaging would also require an MD5 license.

Conclusion

Navigating through the intricate pathways of medical device licensing can be daunting. However, Pharmadocx Consultants are here to assist you with the licensing process. Feel free to reach out for a consultation via their website or call at "+91-7404557227". You may also email your queries to "[email protected]". Together, we can ensure a smoother licensing journey for your medical devices and products.