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CDSCO Manufacturing License for Implantable pacemaker pulse generator

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Introduction

The Central Drugs Standard Control Organisation (CDSCO) is the national regulatory body for Indian pharmaceuticals and medical devices, and serves parallel to the European Medicines Agency of the European Union, the PMDA of Japan, the Food and Drug Administration of the United States and the Medicines and Healthcare products Regulatory Agency of the United Kingdom. Within the CDSCO, the Drug Controller General of India (DCGI) regulates pharmaceutical and medical devices, under the gamut of Ministry of Health & Family Welfare. CDSCO is focused on ensuring the safety, quality and efficacy of drugs, cosmetics and medical devices in India.

Manufacturing licenses play an important role in the medical device industry, ensuring that the products entering the market meet certain standards of quality and safety set by the governing bodies. This blog post will introduce you to the Implantable Pacemaker Pulse Generator, its medical significance, and provide an in-depth look into the licensing aspects associated with manufacturing this medical device. You can access CDSCO's official portal here.

What is an Implantable Pacemaker Pulse Generator?

An Implantable Pacemaker Pulse Generator (IPPG) is a device that has a power supply and electronic circuits designed to produce a periodic electrical pulse meant to stimulate the heart. This device is used as a substitute for the heart's intrinsic pacing system, correcting both continuous and intermittent cardiac rhythm disorders. Inside the human body, this device may use various modes including triggered, inhibited, and asynchronous.

The IPPG is commonly used to regulate heartbeat in patients suffering from arrhythmia, or irregular heartbeat. It can monitor the heart's electrical activities and deliver electrical stimulation when necessary to maintain regular rhythmic beating of the heart.

The Role of CDSCO in Medical Device Regulation

CDSCO has a long history of ensuring the safety, efficacy and quality of drugs, cosmetics and medical devices in India. The organization operates a comprehensive regulatory framework for medical devices, including classification, clinical trials, manufacturing, and sale.

The mission of CDSCO is to safeguard and enhance public health by ensuring the quality, safety and efficacy of drugs, cosmetics and medical devices. It is also responsible for the approval of new drugs and clinical trials, the laying down of the standards for drugs, control over the quality of imported drugs, coordination of the activities of state drug control organizations and providing expert advice with a view of bringing about the uniformity in the enforcement of the drugs and cosmetics act.

How to Manufacture an Implantable Pacemaker Pulse Generator

Fees for Manufacturing License for an Implantable Pacemaker Pulse Generator

In the case of manufacturing an Implantable Pacemaker Pulse Generator, which falls under the risk Class D, an MD9 license is required. The fees for MD9 license is Rs. 50,000 for the license and Rs. 1,000 per product.

Why is a Manufacturing License Necessary for an Implantable Pacemaker Pulse Generator?

Acquiring a manufacturing license is a mandatory requirement to manufacture medical devices in India. It ensures that the medical device production upholds quality and safety standards, thereby safeguarding consumers and patients from substandard products. For medical devices like the Implantable Pacemaker Pulse Generator, regulatory compliance holds utmost importance in the healthcare sector due to the critical nature of their functions.

Steps to Obtain a CDSCO Manufacturing License for an Implantable Pacemaker Pulse Generator

  1. Prepare all necessary documents including Device Master File, Quality Management Certificate, Device Details, Site details etc.
  2. Submit the application with all the required documents to the CDSCO.
  3. Await for approval. The process may require clarifications and additional information.
  4. Overcome any potential challenges. Seek licensed consultation if necessary.

You can learn more about this process here - Manufacturing License Process for Medical Devices

Frequently Asked Questions (FAQs)

Q. What is the risk class of an Implantable Pacemaker Pulse Generator as per Medical Device Rules, 2017?

A. The Implantable Pacemaker Pulse Generator falls under the risk Class D, the highest risk category.

Q. What license is needed to manufacture an Implantable Pacemaker Pulse Generator?

A. To manufacture an Implantable Pacemaker Pulse Generator, an MD9 license is required.

Q. What is the fee for an MD9 license for an Implantable Pacemaker Pulse Generator?

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

Q. Who issues the manufacturing license for an Implantable Pacemaker Pulse Generator?

A. The CDSCO HQ in New Delhi issues the manufacturing license for Class D medical devices like the Implantable Pacemaker Pulse Generator.

Q. Is repackaging of an Implantable Pacemaker Pulse Generator considered manufacturing?

A. 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. Medical Device Rules have been made under the provisions of Drug Act only and hence repackaging of an Implantable Pacemaker Pulse Generator is also considered manufacturing requiring a MD9 license.

Conclusion

Regulatory compliance and acquiring necessary manufacturing licenses can be a daunting task. It requires a comprehensive understanding of the medical device industry and the specific product details. For expert consultation or assistance regarding the CDSCO licensing process, feel free to reach out to Pharmadocx Consultants through their website, or contact them directly at "+91-7404557227" or "[email protected]".

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