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CDSCO Manufacturing License for Foetal Doppler system

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is an indispensable part of India's healthcare and pharmaceutical sector. Lying at the heart of healthcare standardization, the CDSCO plays a crucial role in the Indian healthcare ecosystem. This reputable organization controls the safety, quality, and performance of drugs and medical devices with its stringent regulations and approvals.

In the medical devices industry, manufacturing licenses hold a great value. It is utmost important for a medical device to be manufactured under license from the CDSCO to confirm that the device complies with the national standards of quality, safety, and efficacy.

One such critical medical device is the Foetal Doppler system. This device has an important medical significance, helping to ensure the wellbeing of both the mother and the unborn child during pregnancy. You can find more information about the CDSCO and it's role in regulating such medical devices on their portal, available at CDSCO's Portal.

What is Foetal Doppler system?

A Foetal Doppler system is a non-invasive medical device specifically designed for the detection of foetal heartbeats using ultrasound/Doppler technology. This portable hand-held device is primarily used by healthcare professionals to monitor and verify foetal viability. It works by transmitting ultrasound waves into the abdomen of a pregnant woman, and these waves bounce back as audible heartbeats, when they hit against a moving object like a foetal heart.

The Role of CDSCO in Medical Device Regulation

Established under the Directorate General of Health Services, CDSCO is the apex national regulatory body in India for pharmaceuticals and medical devices. Its mission is to safeguard and enhance public health by ensuring the quality, safety, and efficacy of drugs, cosmetics, and medical devices.

For medical devices like the Foetal Doppler system, the CDSCO provides a regulatory framework which includes the issuance of manufacturing licenses, monitoring the import and manufacture of medical devices, and ensuring that standards for these products are met.

How to manufacture Foetal Doppler system

The manufacturing process of the Foetal Doppler system involves intricate electronics and precise calibrations. It requires a facility with specific machinery, controlled environment, and highly skilled labor. High standards of quality and safety need to be maintained throughout the process, from design and development to packaging and distribution.

Fees for manufacturing license for Foetal Doppler system

As the Foetal Doppler system falls under the Class C risk classification, MD9 license would be required for manufacturing. The fee for the MD9 license is Rs. 50,000, along with an additional fee of Rs. 1,000 for each product.

Why is a Manufacturing License Necessary for Foetal Doppler system?

Obtaining the necessary manufacturing license for a medical device like the Foetal Doppler system is not just a regulatory requisite but also a testament to the compliance with quality and safety standards set by the CDSCO.

In the medical device sector, regulatory compliance holds paramount importance. It aids in protecting patients and consumers from substandard or potentially harmful products. Furthermore, it ensures the continued trust of healthcare professionals in the medical devices that they rely on daily.

Steps to Obtain a CDSCO Manufacturing License for Foetal Doppler system

  1. Ensure that all the pre-requisite items such as Device Master File, Quality Management Certificate, Device details, Site details etc. are in order.
  2. Submit the application to the CDSCO.
  3. Await the review and approval of the application by CDSCO.
  4. Overcome any challenges that may come up during this process with the help of experienced consultants.

Frequently Asked Questions (FAQs)

Q1. What is risk class of Foetal Doppler system as per Medical Device Rules, 2017?

The Foetal Doppler system is classified as a Class C risk device as per the Medical Device Rules, 2017.

Q2. What license in needed to manufacture Foetal Doppler system?

To manufacture the Foetal Doppler system, an MD9 license is required.

Q3. What is fees for MD9 license for Foetal Doppler system?

The fee for an MD9 license for the Foetal Doppler system is Rs. 50,000 for the license and Rs. 1,000 per product.

Q4. Who will issue manufacturing license for Foetal Doppler system?

The CDSCO HQ in New Delhi will issue the manufacturing license for the Foetal Doppler system.

Q5. Is repackaging of Foetal Doppler system 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. Medical Device Rules have been made under the provisions of Drug Act only and hence repackaging of the Foetal Doppler system is also considered manufacturing requiring an MD9 license.

Conclusion

Understanding the complex process of obtaining a manufacturing license for medical devices is a daunting task. But, with the right guidance and expertise, it can be a smooth journey. We at Pharmadocx can offer you that required helping hand Pharmadocx Consultants.

Our team of experts can guide you through the process and assist with overcoming any hurdles. If you need any further consultation or assistance regarding the licensing process, feel free to reach us at "+91-7404557227" or mail us at [email protected].

For detailed information on MD9 license required for Class C & D devices , please read this detailed article here. After all, we understand that compliance is not a destination, but a journey that needs to be navigated with care.

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