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CDSCO Manufacturing License for Scoliosis- treatment electrical stimulation system

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Introduction

Medical devices play a crucial role in diagnosing, preventing, and treating diverse health conditions. In India, the regulation and oversight of these essential tools fall under the jurisdiction of CDSCO (Central Drugs Standard Control Organization). CDSCO's primary responsibility is to ensure the safety, efficacy, and quality of medical devices and pharmaceuticals sold in the Indian market.

An integral aspect of CDSCO's function revolves around the authorization of Manufacturing Licenses for medical devices. These licenses validate the quality production of medical devices while adhering to the requisite standards and guidelines. In the vast landscape of medical devices, the electrical stimulation system for Scoliosis treatment holds substantial medical significance.

Let's get a deeper insight into this specific device, its relevance, and the process of securing a manufacturing license. For more information, you can visit CDSCO's portal here.

What is a Scoliosis- treatment, electrical stimulation system?

As the name suggests, a Scoliosis treatment electrical stimulation system is a medical device specifically engineered to manage spinal curvature, a condition commonly known as Scoliosis. This system applies electrical stimuli to the spinal musculature, creating a force that either stabilizes or limits the further progression of the lateral curvature.

Common procedures using this kind of system include electrical stimulation therapy that is widely propagated as an alternative to traditionally invasive treatments or surgeries.

The Role of CDSCO in Medical Device Regulation

Over time, the Central Drugs Standard Control Organization (CDSCO) has honed its mission to guarantee the safety, efficacy, and quality of medical devices in India. Under its regulatory framework for medical devices, the CDSCO classified devices into four risk classes: Class A, B, C, and D. The Scoliosis-treatment electrical stimulation system falls under the highest risk class, Class D, due to its critical use and application.

How to manufacture a Scoliosis- treatment electrical stimulation system

Manufacturing a Scoliosis treatment electrical stimulation system involves a stringent process in compliance with the guidelines set by CDSCO. Since this device falls under risk Class D, the manufacturing license required is MD9. You can find more information about this specific license here.

Fees for manufacturing license for a Scoliosis- treatment electrical stimulation system

For devices under the Class D risk category, which includes the Scoliosis-treatment electrical stimulation system, the fees charged for an MD9 license is Rs. 50,000. Additionally, there is also a cost of Rs. 1,000 per product.

Why is a Manufacturing License Necessary for a Scoliosis- treatment electrical stimulation system

When we talk about medical devices, especially those associated with critical health conditions, ensuring the utmost quality and safety is paramount. This is where the significance of regulatory compliance comes into play. Having a valid CDSCO manufacturing license verifies compliance with the set guidelines, thereby promoting a trust-factor for the consumers. Moreover, it also plays a critical role in protecting consumers and patients from substandard products.

Steps to Obtain a CDSCO Manufacturing License for a Scoliosis- treatment electrical stimulation system

The process of obtaining a license for manufacturing involves a series of steps, including:

  1. Compiling the necessary pre-requisites and documentation, which might include the Device Master File, Quality Management Certificate, Device Details, Site details, etc.
  2. Submitting the application.
  3. Undergoing scrutiny and evaluation.
  4. Finally, securing approval after satisfactory assessment.

This process, despite appearing straightforward, comes with its set of challenges. To navigate through these and simplify your licensing journey, professional consultation can be invaluable.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of a Scoliosis- treatment electrical stimulation system as per Medical Device Rules, 2017?
A. Class D.

Q2. What license is needed to manufacture a Scoliosis- treatment electrical stimulation system?
A. An MD9 license is required.

Q3. What is the fee for an MD9 license for a Scoliosis- treatment electrical stimulation system?
A. The fee for an MD9 license is Rs. 50,000, and there is an additional cost of Rs. 1,000 per product.

Q4. Who will issue the manufacturing license for a Scoliosis- treatment electrical stimulation system?
A. For devices classified under Class D, the manufacturing license is issued by the CDSCO HQ in New Delhi.

Q5. Is repackaging of a Scoliosis- treatment electrical stimulation system considered manufacturing?
A. Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs and consequently, medical devices, are considered manufacturing. Thus, a license on MD9 is required.

Conclusion

The process of obtaining a manufacturing license from CDSCO for medical devices like a Scoliosis-treatment electrical stimulation system might seem challenging. However, with the right consultation and guidance, this journey can be navigated smoothly. Reach out to Pharmadocx Consultants or call at +91-7404557227 or email us at [email protected] for expert assistance regarding the licensing process.

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