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CDSCO Manufacturing License for Implanted neuromuscular stimulator.

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Introduction

The Central Drugs Standard Control Organization (CDSCO) plays a pivotal role in the Indian healthcare sector. As the national regulatory authority for Indian pharmaceuticals and medical devices, CDSCO ensures that the medical products manufactured and sold in the country meet the necessary standards for safety, effectiveness, and quality. The organization’s responsibilities include the granting of manufacturing licenses, conducting inspections, and monitoring adverse events related to drugs and devices.

Given the critical role that medical devices play in healthcare, it is essential for manufacturers to obtain the appropriate licenses. Not only does this ensure compliance with the norms laid down by CDSCO but it also ensures that the devices produced are safe and effective for their intended use.

In this blog, we will be discussing the CDSCO manufacturing license for an Implanted neuromuscular stimulator, a device that significantly improves the life of those with paralyzed legs. You can find more information directly on CDSCO's portal here.

What is an Implanted neuromuscular stimulator?

An Implanted neuromuscular stimulator is a sophisticated medical device designed to improve the gait of patients with paralyzed legs. It operates by providing electrical stimulation to the peroneal or femoral nerve in the leg. This causes the leg muscles to contract, aiding in movement and stride.

This device comprises an implanted receiver equipped with electrodes that are positioned around a patient's nerve, and an external transmitter that sends stimulating pulses across the patient's skin to the implanted receiver. The transmitter is activated by a heel switch in the patient’s shoe.

The Role of CDSCO in Medical Device Regulation

CDSCO’s mission is to ensure the safety, quality, and performance of medical devices distributed in the domestic market. This is achieved through a robust regulatory framework that comprises standards for manufacturing practices, quality control procedures, post-market surveillance, and vigilance.

The organization has a rich history of protecting public health by regulating medical devices, including an Implanted neuromuscular stimulator. The standardized guidelines laid down by CDSCO facilitate the production of safe and effective medical devices and promote consumer confidence.

How to manufacture an Implanted neuromuscular stimulator

Manufacturing an Implanted neuromuscular stimulator is a sophisticated process that should comply with the guidelines and regulations set by CDSCO. Since the device falls under Class D risk category, the required manufacturing license is MD9.

Fees for manufacturing license for Implanted neuromuscular stimulator

As per the current fee structure, the license fee for MD9 is Rs. 50,000, and an additional fee of Rs. 1,000 per product is charged.

Why is a manufacturing license necessary for an Implanned neuromuscular stimulator?

  • Ensuring Quality and Safety: Licenses are mandatory to ensure that the manufacturing processes adhere to quality and safety protocols.
  • Regulatory Compliance: Compliance with regulations is vital to operate legally in the healthcare sector.
  • Consumer Protection: Manufacturing licenses protect consumers and patients from substandard or counterfeit products.

Steps to Obtain a CDSCO Manufacturing License for Implanned neuromuscular stimulator

  • Prepare the necessary documents, such as the Device Master File, Quality Management Certificate, Device Details, Site details, etc.
  • Submit the application to the CDSCO.
  • Wait for the application to be approved.
  • Navigate any challenges that may arise during this process.

For a detailed description of the license procedure for Class D devices, refer to this article.

Frequently Asked Questions (FAQs)

Q.1 What is the risk class of Implanted neuromuscular stimulator as per Medical Device Rules, 2017? The risk class of an Implanned neuromuscular stimulator is Class D.

Q.2 What license is needed to manufacture Implanned neuromuscular stimulator? The MD9 license is needed to manufacture Implanned neuromuscular stimulator.

Q.3 What is the fees for MD9 license for Implanned neuromuscular stimulator? The fee for an MD9 license is Rs. 50,000, with an additional fee of Rs. 1,000 per product.

Q.4 Who will issue manufacturing license for Implanned neuromuscular stimulator? The CDSCO HQ in New Delhi will issue the manufacturing license for Implanned neuromuscular stimulator.

Q.5 Is repackaging of Implanned neuromuscular stimulator considered manufacturing? Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing which includes medical devices as well. Therefore, the repackaging of Implanned neuromuscular stimulator is also considered manufacturing, requiring an MD9 license.

Conclusion

Manufacturing a medical device, such as an Implanned neuromuscular stimulator, and obtaining the appropriate licenses is complex and requires understanding of various regulations. For assistance or consultation regarding the licensing process, we recommend reaching out to Pharmadocx Consultants. They can be contacted through their website, by phone at "+91-7404557227", or via email at "[email protected]".

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