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CDSCO Manufacturing License for Implanted diaphragmatic/ph renic nerve stimulator.

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is part and parcel of India’s medical landscape. It plays a critical role in ensuring quality control and safety in the production of medical equipment, protecting millions of patients from substandard products. One of the many responsibilities of the CDSCO is the issuance of manufacturing licenses for a wide array of medical devices - a crucial facet in safeguarding the industry's integrity.

Manufacturing licenses are not merely formalities but vital prerequisites in the medical device industry. They create a standard and enforce quality and safety regulations, thus protecting the consumers and patients from ineffective or harmful products. Every medical device, from low-risk to high-risk classifications, requires a manufacturing license before it can be produced and distributed. Today we will be focusing on the Implanted diaphragmatic/phrenic nerve stimulator - a device of high medical significance due to its fundamental role in sustaining the life of patients struggling with certain types of respiratory illnesses.

What is an Implanted Diaphragmatic/Phrenic Nerve Stimulator?

An Implanted Diaphragmatic/Phrenic Nerve Stimulator is a device designed to provide electrical stimulation to a patient's phrenic nerve. This in turn leads to the rhythmic contraction of the diaphragm, inducing breathing in patients who have hypoventilation caused by brain stem disease, high cervical spinal cord injury, or chronic lung disease. The stimulator consists of an implanted receiver equipped with electrodes and an external transmitter that sends stimulating pulses across the patient's skin to the implanted receiver.

The Role of CDSCO in Medical Device Regulation

The mission of CDSCO spans ensuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices available to the citizens of India. One of the manners in which it accomplishes this is through a robust regulatory framework for medical devices, firmly in place to keep a check on every product that enters the market.

How to manufacture an Implanted Diaphragmatic/Phrenic Nerve Stimulator

For the device to be created, it must pass through a series of regulatory checks, and a manufacturing license must be obtained.

Fees for manufacturing license for an Implanted Diaphragmatic/Phrenic Nerve Stimulator

As a Class D device, an MD9 license is required, which has a fee of Rs. 50,000 for the license and Rs. 1,000 per product.

Why is a Manufacturing License Necessary for an Implanted Diaphragmatic/Phrenic Nerve Stimulator?

Manufacturing licenses for medical devices aren't optional – they are mandatory. They ensure quality control, safety of manufacture, and regulatory enforcement in the healthcare sector. Apart from keeping unethical practices in check, they also play a critical role in protecting consumers and patients from health hazards posed by substandard products.

Steps to Obtain a CDSCO Manufacturing License for an Implained Diaphragmatic/Phrenic Nerve Stimulator

The prerequisites for obtaining a manufacturing license include having a Device Master File, a Quality Management Certificate, and detailed information about the device and the manufacturing site. The application process can be tedious, but with carefully prepared documentation and proper submission, the approval can be obtained in a streamlined timeframe.

Frequently Asked Questions (FAQs)

  • Q. What is the risk class of an Implanted Diaphragmatic/Phrenic Nerve Stimulator as per Medical Device Rules, 2017? A. The Implanted Diaphragmatic/Phrenic Nerve Stimulator falls under Risk Class D.

  • Q. What license is needed to manufacture an Implanted Diaphragmatic/Phrenic Nerve Stimulator? A. An MD9 license is required to manufacture an Implanted Diaphragmatic/Phrenic Nerve Stimulator.

  • Q. What is the fees for an MD9 license for an Implanted Diaphragmatic/Phrenic Nerve Stimulator? A. The fees for an MD9 license is Rs. 50,000 for the license plus Rs. 1,000 per product.

  • Q. Who will issue the manufacturing license for an Implanted Diaphragmatic/Phrenic Nerve Stimulator? A. The CDSCO HQ in New Delhi will issue the license for Class D devices like the Implanted Diaphragmatic/Phrenic Nerve Stimulator.

  • Q. Is repackaging of an Implanted Diaphragmatic/Phrenic Nerve Stimulator 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 Implanted Diaphragmatic/Phrenic Nerve Stimulator is also considered manufacturing requiring an MD9 license.

Conclusion

The path to obtaining a manufacturing license can be complex, but necessary for upholding the quality and safety of medical products in the market. If you need consultation or assistance regarding the licensing process, do not hesitate to reach out to Pharmadocx Consultants, call "+91-7404557227" or email at "[email protected]". We have the expertise to guide you through the process and ensure you meet all requirements. For more on MD9, read this article. Remember, maintaining regulatory compliance not only safeguards your business, but also the millions of patients who rely on medical devices for their health.

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