Published on

CDSCO Manufacturing License for Electrically- powered trephine system

Authors
  • avatar
    Name
    CDSCO Licenses Blog
    Twitter

Introduction

Central Drugs Standard Control Organization (CDSCO) plays a pivotal role in Indian healthcare sector, being responsible for safeguarding and promoting public health by assuring the safety, efficacy and quality of drugs, cosmetics, and medical devices. In the world of medical devices, a critical aspect that determines the viability of the product is the manufacturing license, regulated by CDSCO.

One such medical device is the Electrically- powered trephine system, which holds significant medical relevance mainly in dermatological and plastic surgery. As a medical device manufacturer, understanding the complexities surrounding the licensing process for these systems is critical. You can get more information on the CDSCO's portal, at CDSCO Portal.

What is Electrically- powered Trephine System?

A trephine system is a rotary surgical device consisting of a motor and a cylindrical or trephine insertion portion. The blade is beveled on one side. Electrically- powered trephine systems are most commonly used in procedures that demand the removal of the intervertebral disc, other hard soft tissues, or soft tissues.

The Role of CDSCO in Medical Device Regulation

Incepting as a nodal agency for effective enforcement of the Drugs and Cosmetics Act, CDSCO’s principal objective revolves around developing the highest standards for drugs, cosmetics, and medical devices. The regulatory framework functions via a risk-based approach, where, based on the risk associated with the use of devices, the products are classified into four classes - A, B, C, and D.

How to Manufacture Electrically- Powered Trephine System

Manufacturing an Electrically- powered trephine system entails an intricate process involving designing, testing, and adhering to stringent quality standards.

Fees for Manufacturing License for Electrically- Powered Trephine System

As the device falls under Risk Class B, the requisite license will be MD5, which costs Rs. 5000 for the license and Rs. 500 per product.

Why is a Manufacturing License Necessary for Electrically- Powered Trephine System?

A manufacturing license serves multiple purposes beyond just legal compliance. It is a testament to a company's adherence to quality standards and ensures safe product output. Moreover, it shields consumers and patients from substandard and potentially harmful products.

Steps to Obtain a CDSCO Manufacturing License for Electrically- Powered Trephine System

Getting a manufacturing license requires the submission of essential documents such as a Device Master File, Quality Management Certificate, Device Details, Site details, etc. This is followed by a series of steps:

  • Application submission
  • Evaluation
  • Approval
  • License Issuance

Despite the seemingly straightforward process, one might encounter challenges which can easily be overcome by seeking expert guidance.

Frequently Asked Questions (FAQs)

Q1. What is risk class of Electrically- powered trephine system as per Medical Device Rules, 2017?

  • The Electrically- powered trephine system falls under Risk Class B as per Medical Device Rules, 2017.

Q2. What license in needed to manufacture Electrically- powered trephine system?

  • To manufacture Electrically- powered trephine system, one needs an MD5 license.

Q3. What is fees for MD5 license for Electrically- powered trephine system?

  • The fees for an MD5 license for manufacturing Electrically- powered trephine system is Rs. 5000 for the license and Rs. 500 per product.

Q4. Who will issue manufacturing license for Electrically- powered trephine system?

  • The state FDA will issue the manufacturing license for Electrically- powered trephine system.

Q5. Is repackaging of Electrically- powered trephine system 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. Hence, repackaging of Electrically- powered trephine system is also considered manufacturing requiring a license on MD5.

Conclusion

Embarking on the journey of obtaining a manufacturing license can often be overwhelming. Sink your worries with Pharmadocx Consultants. Connect with us at "+91-7404557227" or email us at "[email protected]" for a streamlined and stress-free experience. Also, do check out our informative piece on obtaining an MD5 license here.

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