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CDSCO Manufacturing License for Deep brain electrical stimulation system

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Introduction

The Central Drugs Standard Control Organization (CDSCO) plays an indispensable role in regulating and approving the manufacturing, distribution, and sale of medical devices in India. As the statutory body, and the National Regulatory Authority of India, CDSCO sets stringent standards to ensure that every medical device in the market is safe and effective.

In an industry where human lives are at stake, manufacturing licenses serve as a pivotal tool in ensuring that medical devices adhere to national and international standards of quality and safety. They act as a guarantee that the manufacturing process of a device follows the norms outlined by the regulatory authority.

In this article, we will be discussing the Deep brain electrical stimulation system, a Class D medical device of paramount significance in treating neurological disorders. To know more about CDSCO and their regulations, please visit their portal here.

What is Deep brain electrical stimulation system?

A Deep brain electrical stimulation system is a medical device designed to deliver controlled electrical impulses to specific areas in the deep structures of the brain. This system aims to aid in the management and treatment of severe movement disorders, psychiatric problems, and chronic intractable pain.

Certain conditions, such as Parkinson's disease, dystonia, obsessive-compulsive disorder, and epilepsy, can particularly benefit from the use of a Deep brain electrical stimulation system. The device can provide varying degrees of symptomatic relief to patients who don't respond well to medications.

The Role of CDSCO in Medical Device Regulation

Established under the Drugs and Cosmetics Act, CDSCO's mission is to protect and promote public health in India. It achieves this by ensuring the safety, efficacy, and quality of drugs and medical devices. In the sphere of medical devices, CDSCO is responsible for setting regulation standards, approving devices, and granting manufacturing licenses.

How to Manufacture Deep brain electrical stimulation system

Manufacturing a Deep brain electrical stimulation system requires a thorough understanding of the device's medical implications and strict adherence to the technical specifications laid down by health experts. It also requires compliance with CDSCO's regulatory framework and obtaining the necessary licenses.

Fees for Manufacturing License for Deep brain electrical stimulation system

To manufacture a Deep brain electrical stimulation system, a Class D device, an MD9 license is required. The fee for an MD9 license is Rs. 50,000, and a fee of Rs. 1,000 is charged for each product. For more information on acquiring an MD9 license, please click here.

Why is a Manufacturing License Necessary for Deep brain electrical stimulation system?

Acquiring a manufacturing license is mandatory under the law for the manufacture of medical devices. This requirement is there to uphold the quality and ensure the safety of the manufacturing process. A license reflects that a manufacturer is compliant with the regulations and protocols set forth by CDSCO.

It helps safeguard patients and consumers from substandard devices and encourages manufacturers to maintain high standards in their production process.

Steps to Obtain a CDSCO Manufacturing License for Deep brain electrical stimulation system

  1. Make sure you have all the necessary documents ready: Device Master File, Quality Management Certificate, Device Details, and Site details.
  2. Submit your application with all the required documents to the CDSCO.
  3. Wait for the application review and approval process.
  4. Overcome potential obstacles by seeking professional consultation.

Frequently Asked Questions (FAQs)

Q1: What is the risk class of the Deep brain electrical stimulation system as per Medical Device Rules, 2017?

Class D, which is the highest risk category.

Q2: What license is needed to manufacture a Deep brain electrical stimulation system?

An MD9 license is required according to its risk classification.

Q3: What is the fees for an MD9 license for a Deep brain electrical stimulation system?

The fee for an MD9 license is Rs. 50,000, plus Rs. 1,000 per product.

Q4: Who will issue the manufacturing license for a Deep brain electrical stimulation system?

For Class D devices, CDSCO HQ in New Delhi will issue the license.

Q5: Is repackaging of a Deep brain electrical stimulation system considered manufacturing?

Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of medical devices is also considered manufacturing. It would require an MD9 license.

Conclusion

The process to obtain a CDSCO manufacturing license for a Deep brain electrical stimulation system can be complex. However, you don't have to navigate the intricacies alone. If you need consultation or assistance regarding the licensing process, don't hesitate to reach out to Pharmadocx Consultants. You can visit their website here, call them at +91-7404557227, or send an email to [email protected]. They are experts in the field and can guide you through the entire process, ensuring a smooth and hassle-free experience.

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