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CDSCO Manufacturing License for Echoencephalogr aph.

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is India’s central regulatory body that governs the safety, efficacy, and quality of drugs, cosmetics, diagnostics, biologicals, and medical devices. It plays pivotal roles like approval of new drugs and setting standards for manufacturing processes. A division of the CDSCO known as the Medical Device and Diagnostics Division is responsible for the regulation of the medical device industry in India.

One such device that requires regulatory compliance is the echoencephalograph. This neurological device is essential for measuring intracranial interfaces and blood flow velocity to and in the head, providing critical insight into the patient's neurological health.

For more details, visit the CDSCO's portal here.

What is an Echoencephalograph?

An echoencephalograph is an ultrasonic scanning device featuring A-scan, B-scan and doppler systems. It employs noninvasive transducers to measure intracranial interfaces and the blood flood velocity to and in the head. It is widely used in diagnosing neurological conditions.

The Role of CDSCO in Medical Device Regulation

CDSCO has a rich history of ensuring the safety and efficacy of various health products used in India. The body's key functions include setting standards for the manufacturing, import, conduct of clinical trials and laying down the procedure for the enforcement of these set standards. It particularly stresses on the regulation of medical devices, which are classified into four risk classes-A, B, C, and D.

How to Manufacture an Echoencephalograph

Details related to the manufacture of an echoencephalograph can be reviewed on the official CDSCO portal. The manufacturing process involves following strict guidelines and SWP (Standard Working Procedures) to ensure the device's safety, performance, and quality.

Fees for Manufacturing License for an Echoencephalograph

Given that an echoencephalograph falls under the Class C risk category, the manufacturing process would require an MD9 license. The fees for this license are Rs 50,000, with an added cost of Rs. 1,000 per device product. Visit this link for detailed information.

Why is a Manufacturing License Necessary for an Echoencephalograph?

Acquiring a manufacturing license before manufacturing an echoencephalograph is mandatory under the CDSCO regulations. This license is a testimony to the compliance with safety and quality standards, thus ensuring patient safety and quality healthcare. It prevents the manufacturing and market of substandard medical devices.

Steps to Obtain a CDSCO Manufacturing License for an Echoencephalograph

  1. Preparation of the required documentation such as Device Master File, Quality Management Certificate, Device Details, Site details etc.
  2. Submission of the application for medical device manufacturing license.
  3. Review of the application by regulatory body.
  4. Approval of application post stringent evaluation by regulatory body.

Frequently Asked Questions (FAQs)

Q1. What is risk class of an echoencephalograph as per Medical Device Rules, 2017?

  • Answer: An echoencephalograph belongs to the Class C risk category.

Q2. What license is needed to manufacture an echoencephalograph?

  • Answer: Manufacturing an echoencephalograph requires an MD9 license.

Q3. What is fees for MD9 license for an echoencephalograph?

  • Answer: The fee for an MD9 license for an echoencephalograph comes to Rs. 50,000, with an additional cost of Rs. 1,000 per device product.

Q4. Who will issue manufacturing license for an echoencephalograph?

  • Answer: The CDSCO HQ in New Delhi will issue the manufacturing license for an echoencephalograph.

Q5. Is repackaging of an echoencephalograph considered manufacturing?

  • Answer: Yes, under the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. This extends to medical devices as well, since they are classified as drugs. Therefore, repackaging of an echoencephalograph would require the appropriate MD9 manufacturing license.

Conclusion

This article provides a brief overview of the process involved in obtaining a CDSCO manufacturing license for an echoencephalograph. It is critical to adhere to regulatory standards to ensure high quali+

This process can often be challenging, /even formidable. In case you need consultation or assistance with the licensing process, do not hesitate to reach out to our experts at Pharmadocx Consultants.

Visit their website at Pharmadocx Consultants or call at +91-7404557227. Alternatively, you may also email them at [email protected].

Follow the legal pathway to successful medical device manufacturing with expert assistance!

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