CDSCO Manufacturing License for Foetal cardiac monitor

Introduction

The Central Drugs Standard Control Organization (CDSCO) plays a vital role in the monitoring and control of medical devices in India. The organization is tasked with the primary responsibility of ensuring the safety, efficiency, and quality of medical devices used across the nation. One of its paramount responsibilities involves issuing licenses for the manufacturing of these medical devices.

In the medical device industry, manufacturing licenses are of supreme importance. They serve as a guarantee that the manufacturing process adheres to the stringent quality and safety standards put in place by regulatory bodies such as the CDSCO.

In this blog post, we will be discussing Foetal Cardiac Monitor, an essential medical device used in healthcare. The intended use of this device is to detect, measure, and display foetal heart activity during the perinatal period.

For more information, please visit CDSCO's portal page at here.

• What is Foetal Cardiac Monitor?
• The Role of CDSCO in Medical Device Regulation
• How to Manufacture Foetal Cardiac Monitor
• Fees for Manufacturing License for Foetal Cardiac Monitor
• Why is a Manufacturing License Necessary for Foetal Cardiac Monitor?
• Steps to Obtain a CDSCO Manufacturing License for Foetal Cardiac Monitor
• Frequently Asked Questions (FAQs)
• Conclusion

What is Foetal Cardiac Monitor?

A Foetal Cardiac Monitor is a mains electricity (AC-powered) device designed to provide a real-time assessment of the unborn baby’s heart rate. The device can monitor foetal heart activity throughout the pregnancy and notably during the perinatal period, which is immediately before and after birth.

The Foetal Cardiac Monitor is commonly used in hospitals or maternity care centres during antenatal check-ups or during labour to evaluate the baby's condition and detect any potential distress. Its usage is crucial in gynecology and obstetric procedures.

The Role of CDSCO in Medical Device Regulation

Fundamentally, the CDSCO is tasked with safeguarding public health in India by ensuring that all medical devices and drugs meet the required standards of safety, efficacy, and quality. Moreover, the CDSCO plays a critical role in the formulation of regulatory measures, amendments to Acts and Rules, and laying down guidelines for enforcement of statutory provisions.

In the realm of medical device regulation, CDSCO has set up a detailed and structured regulatory framework that every manufacturer must follow. This framework extends to the Foetal Cardiac Monitor as well.

How to Manufacture Foetal Cardiac Monitor

The manufacturing process of a Foetal Cardiac Monitor encompasses different stages. Manufacturers must comply with best practices in design, raw material procurement, production, quality testing, and packaging to ensure the safety and efficiency of the monitor.

Fees for Manufacturing License for Foetal Cardiac Monitor

Since the Foetal Cardiac Monitor falls under the Class C category, Class C license or MD9 is required to manufacture it. The fees for this license are Rs. 50,000, and an additional Rs. 1,000 is charged per product.

Why is a Manufacturing License Necessary for Foetal Cardiac Monitor?

Obtaining a manufacturing license is not just a procedural necessity but also a commitment to safety, quality, and responsibility towards patients. A license ensures that the medical device, in this case, a Foetal Cardiac Monitor, meets international and national regulations. Moreover, a license protects consumers and patients from substandard, harmful medical products.

Steps to Obtain a CDSCO Manufacturing License for Foetal Cardiac Monitor

1. Ensure all prerequisites like Device Master File, Quality Management Certificate, Device Details, Site details, etc., are met.

2. Prepare and submit a detailed application.

3. Cooperate during inspection and review.

4. Follow up until license approval.

Each of these steps can be unchartered territory, and professional help can make the journey smoother. For more details on the Class C license, follow this link

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Foetal Cardiac Monitor as per Medical Device Rules, 2017?

The risk class of Foetal Cardiac Monitor as per Medical Device Rules, 2017, is Class C.

Q2. What license is needed to manufacture Foetal Cardiac Monitor?

To manufacture a Foetal Cardiac Monitor, an MD9 license is required.

Q3. What is the fee for MD9 license for Foetal Cardiac Monitor?

The fee for the MD9 license for Foetal Cardiac Monitor is Rs. 50,000, and an additional fee of Rs. 1,000 charged per product.

Q4. Who will issue the manufacturing license for Foetal Cardiac Monitor?

For Class C devices like Foetal Cardiac Monitor, the license will be issued by CDSCO HQ in New Delhi.

Q5. Is repackaging of Foetal Cardiac Monitor considered manufacturing?

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. Thus, repackaging of Foetal Cardiac Monitor is considered manufacturing, requiring an MD9 license.

Conclusion

We hope this blog post offered valuable insights into the regulatory landscape surrounding the Foetal Cardiac Monitor, its manufacturing license, and associated fees. The process of obtaining a license could be complex, and professional guidance can be of immense help.

For consultation or assistance regarding the licensing process, don't hesitate to reach out to Pharmadocx Consultants, call on +91-7404557227 or write an email to [email protected].