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CDSCO Manufacturing License for Implanted cerebellar stimulator.

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Introduction

The Central Drugs Standard Control Organization (CDSCO) stands as a vital authority in India, spearheading the regulation of medical devices. It serves the noble purpose of ensuring that the medical devices produced and used within the country meet the necessary safety and quality standards. As part of their mandate, the CDSCO necessitates that manufacturing licenses are obtained for all medical device production. This regulation ensures that the production process adheres to the established guidelines, thus guaranteeing quality medical devices for the intended use.

Among such devices is the Implanted Cerebellar Stimulator, a crucial component in the medical sector, employed in the treatment of intractable epilepsy, spasticity, and some movement disorders. The importance of this device underscores the need for the provision of a CDSCO-approved manufacturing license. For more information on the licensing process, visit the CDSCO portal via this link.

What is an Implanted Cerebellar Stimulator?

An Implanted Cerebellar Stimulator is a medical device that is surgically positioned within a patient's cerebellar cortex. Its primary function is to electrically excite the cerebellum, leading to relief from conditions such as epilepsy, spasticity, and some movement disorders. The device includes an implanted receiver with electrodes and an external transmitter responsible for transmitting stimulating pulses to the implanted receiver.

The Role of CDSCO in Medical Device Regulation

Established to protect the public health, the CDSCO remains committed to its mission of regulating and controlling the quality standards of drugs, cosmetics, and medical devices within the nation. It has implemented a comprehensive regulatory framework, with different risk classes, that covers the design, manufacture, clinical evaluation, and post-market surveillance of medical devices like the Implanted Cerebellar Stimulator.

How to Manufacture an Implanted Cerebellar Stimulator

The manufacturing of an Implanted Cerebellar Stimulator involves a highly technical and meticulous fabrication process due to its sophisticated nature and the need for utmost precision in its operation.

Fees for Manufacturing License for an Implanted Cerebellar Stimulator

For a high-risk medical device such as an Implanted Cerebellar Stimulator that falls under the risk class D, the required license is MD9. The fees for an MD9 license is Rs. 50,000, with an additional Rs. 1,000 for each product.

Why is a Manufacturing License Necessary for an Implanted Cerebellar Stimulator?

Manufacturing licenses are mandatorily required for the production of the Implanted Cerebellar Stimulator. They ensure the quality, safety, and compliance of the device with the regulatory guidelines of the healthcare sector. Further, they protect patients and end-users from potentially hazardous or substandard medical devices by regulating their production process.

Steps to Obtain a CDSCO Manufacturing License for an Implanted Cerebellar Stimulator

  1. Prepare all necessary documents including Device Master File, Quality Management Certificate, Device Details, Site details, and many others.
  2. Submit the application alongside all essential documents.
  3. Await assessment and approval.
  4. Upon approval, proceed with the medical device manufacturing, adhering to the set guidelines.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of the Implanted Cerebellar Stimulator as per Medical Device Rules, 2017?
The Implanted Cerebellar Stimulator falls under risk class D.

Q2. What license is needed to manufacture the Implanted Cerebellar Stimulator?
The required license for manufacturing the Implanted Cerebellar Stimulator is MD9.

Q3. What are the fees for an MD9 license for an Implanted Cerebellar Stimulator?
The fees for an MD9 license for the Implanted Cerebellar Stimulator are Rs. 50,000 for the license and Rs. 1,000 per product.

Q4. Who will issue a manufacturing license for the Implanted Cerebellar Stimulator?
The manufacturing license for the Implanted Cerebellar Stimulator (a Class D medical device) will be issued by the CDSCO HQ in New Delhi.

Q5. Is repackaging of the Implanted Cerebellar Stimulator considered manufacturing?
Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. As medical devices such as the Implanted Cerebellar Stimulator are also drugs, repackaging also requires a license, specifically the MD9 license.

Conclusion

For expert assistance or consultation regarding the licensing process for an Implanted Cerebellar Stimulator, feel free to reach out to Pharmadocx Consultants via their website or make a direct call to "+91-7404557227". You may also send an email to "[email protected]". Pharmadocx Consultants stand ready to assist you.

For more information on the MD9 license requirement, please visit this link.

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