CDSCO Manufacturing License for Ingestible event marker.

Introduction

The Central Drugs Standard Control Organization (CDSCO) is India's principal regulatory body for pharmaceuticals and medical devices. Under the Ministry of Health and Family Welfare, Government of India, it's responsible for ensuring public health safety by monitoring and regulating the safety, quality, and efficacy of drugs, cosmetics, and medical devices manufactured and sold in the country. The manufacturing licenses issued by the CDSCO are one such mechanism that ensures that medical device manufacturers meet set standards and quality parameters to ensure patient safety and efficacy of the device.

In this context, understanding the CDSCO regulation for specific medical devices becomes crucial. One such medical device is the Ingestible Event Marker. The Ingestible Event Marker plays a significant role in the medical field and is critical for specific patient groups. To know more about the CDSCO regulations, you can visit their portal here.

What is an Ingestible Event Marker?
Role of CDSCO in Medical Devices Regulation
How to manufacture the Ingestible Event Marker
Fees for the manufacturing license for Ingestible Event Marker
Why is a Manufacturing License Necessary for the Ingestible Event Marker?
Steps to Obtain a CDSCO Manufacturing License for the Ingestible Event Marker
Frequently Asked Questions (FAQs)
Conclusion

What is an Ingestible Event Marker?

An Ingestible Event Marker (IEM) is a medical device used to record specific time-stamped, patient-logged events. The ingestible device communicates wirelessly with an external recorder upon ingestion. It logs the time and date of ingestion and provides the unique serial number of the ingestible device. This device is used predominantly in monitoring medication adherence in patients.

Role of CDSCO in Medical Devices Regulation

The history of CDSCO can be traced back to the objective of creating a comprehensive regulatory and monitoring body to ensure public health safety in India. With advancements in technology and the increasing complexity of medical devices, the CDSCO has adopted a comprehensive regulatory framework for medical devices.

How to manufacture the Ingestible Event Marker

The manufacturing process of the Ingestible Event Marker needs to follow certain technical specifications and quality control processes. The manufacturer needs to obtain an MD9 license, specific for Class C devices, to be legally allowed to manufacture this medical device in India.

Fees for the manufacturing license for Ingestible Event Marker

The fees for obtaining the MD9 license is Rs. 50,000 and an additional Rs. 1,000 per product. For more details on the MD9 license, refer to this article here.

Why is a Manufacturing License Necessary for the Ingestible Event Marker?

The production of medical devices, particularly one like the Ingestible Event Marker, needs to strictly comply with the specific standards and specifications defined by the regulatory body to uphold quality, safety, and efficacy. A license is mandatory to ensure these parameters are met, reducing the incidence of substandard products and protecting patients.

Steps to Obtain a CDSCO Manufacturing License for the Ingestible Event Marker

Submit necessary documents including the Device Master File, Quality Management Certificate, Device Details, Site details, among others.
Pay the specified fee for the license application.
Await approval from the CDSCO post their review process.
Overcome common challenges with the right consultation and guidance.

Frequently Asked Questions (FAQs)

Q: What is the risk class of Ingestible Event Marker as per Medical Device Rules, 2017? A: The Ingestible Event Marker is categorized as a Class C device as per the Medical Device Rules, 2017.
Q: What license is needed to manufacture the Ingestible Event Marker? A: An MD9 license is needed to manufacture the Ingestible Event Marker.
Q: What is the fee for the MD9 license for the Ingestible Event Marker? A: The fees for the MD9 license is Rs. 50,000 and an additional Rs. 1,000 per product.
Q: Who will issue the manufacturing license for the Ingestible Event Marker? A: The CDSCO HQ in New Delhi issues the manufacturing license for Class C devices such as Ingestible Event Marker.
Q: Is repackaging of the Ingestible Event Marker considered manufacturing? A: Yes, as per the Drugs and Cosmetics Act, repackaging is equivalent to manufacturing. Hence, repackaging of the Ingestible Event Marker also requires an MD9 license.

Conclusion

The regulation and licensing process might seem daunting, but with the right guidance and assistance, it can be navigated smoothly. If you need any help or have queries regarding the licensing process, you can reach out to Pharmadocx Consultants. They have experienced professionals who can assist you in navigating the regulatory framework and simplify the licensing process. Visit their website www.pharmadocx.com, call them at +91-7404557227, or drop an email to [email protected].