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CDSCO Manufacturing License for Brain-responsive electrical stimulation system
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Introduction
The Central Drugs Standard Control Organization (CDSCO) is the apex body in India responsible for the regulation of medical devices and pharmaceuticals. It has a significant role in protecting and advancing public health by ensuring the safety, efficacy and quality of the drugs, cosmetics and medical devices available to the population. The manufacturing licenses for medical devices, issued by CDSCO, is inarguably a significant aspect for any company willing to manufacture medical devices in India.
In the advancing medical industry, innovative devices are being manufactured that have the power to revolutionize health care. One such device is the brain-responsive electrical stimulation system, a vital tool with remarkable medical significance, especially for patients suffering from neurological disorders like epilepsy.
For more detailed information regarding the CDSCO and its various functions, visit the official portal here.
- What is a Brain-responsive electrical stimulation system?
- The Role of CDSCO in Medical Device Regulation
- How to manufacture a Brain-responsive electrical stimulation system
- Fees for manufacturing license for Brain-responsive electrical stimulation system
- Why is a Manufacturing License Necessary for Brain-responsive electrical stimulation system?
- Steps to Obtain a CDSCO Manufacturing License for Brain-responsive electrical stimulation system
- Frequently Asked Questions (FAQs)
- Conclusion
What is a Brain-responsive electrical stimulation system?
The brain-responsive electrical stimulation system is an advanced medical device explicitly designed to manage and control neurological disorders like epilepsy. It monitors brain activity continuously and provides electrical stimuli to seizure foci as required.
Used primarily in the treatment of epilepsy and other similar neurological disorders, this system can detect epileptic seizures and deliver electrical pulses to stop the seizures, significantly improving the patient's quality of life.
The Role of CDSCO in Medical Device Regulation
The Central Drugs Standard Control Organisation (CDSCO) is the national regulatory body for Indian pharmaceuticals and medical devices, implemented under the Drugs and Cosmetics Act of 1940. Its mission is to safeguard and enhance public health by ensuring the safety, efficacy and quality of drugs, cosmetics and medical devices. CDSCO is responsible for approving new drugs, conducting clinical trials, controlling the quality of imported drugs in the country and coordinating the activities of State Drug Control Organizations.
How to manufacture a Brain-responsive electrical stimulation system
The manufacturing process of a brain-responsive electrical stimulation system involves intricate and precise procedures, adhering strictly to the guidelines set by the CDSCO. This ensures the production of high-quality, safe, and effective devices that meet the required standards for treating patients with neurological disorders effectively.
Fees for manufacturing license for Brain-responsive electrical stimulation system
For manufacturing a Class D medical device such as the brain-responsive electrical stimulation system, an MD9 license is required. The fee for an MD9 license is Rs. 50,000 along with Rs. 1,000 per product.
Why is a Manufacturing License Necessary for Brain-responsive electrical stimulation system?
A manufacturing license is mandatory for the production of all medical devices. This not only guarantees standard quality and safety in the medical device production, but it also underpins the significance of regulatory compliance in the healthcare sector.
A licensed product gives consumers and patients trust that the device has undergone rigorous examination, ensuring safety and quality, protecting them from substandard, and potentially harmful, products.
Steps to Obtain a CDSCO Manufacturing License for Brain-responsive electrical stimulation system
The process of obtaining a manufacturing license from CDSCO includes providing necessary documents such as Device Master File, Quality Management Certificate, Device Details, and Site details. The application process runs from the initial submission of documents to their eventual approval, navigating through various challenges that may arise during the process.
Frequently Asked Questions (FAQs)
Q. What is the risk class of Brain-responsive electrical stimulation system as per Medical Device Rules, 2017?
A. The risk class of Brain-responsive electrical stimulation system as per Medical Device Rules, 2017, is Class D.
Q. What license is needed to manufacture Brain-responsive electrical stimulation system?
A. To manufacture Brain-responsive electrical stimulation system, an MD9 license is required.
Q. What is the fees for MD9 license for Brain-responsive electrical stimulation system?
A. The fees for the MD9 license for Brain-responsive electrical stimulation system is Rs. 50,000 for the license and Rs. 1,000 per product.
Q. Who will issue manufacturing license for Brain-responsive electrical stimulation system?
A. The manufacturing license for Brain-responsive electrical stimulation system will be issued by CDSCO HQ in New Delhi.
Q. Is repackaging of Brain-responsive electrical stimulation system 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 Brain-responsive electrical stimulation system is also considered manufacturing requiring an MD9 license.
Conclusion
It's crucial to understand and navigate the process of acquiring the necessary licenses for manufacturing medical devices in compliance with the regulations set by the CDSCO. Should you require consultation or assistance with the licensing process for a brain-responsive electrical stimulation system, feel free to reach out to Pharmadocx Consultants. You can visit their website https://www.pharmadocx.com, call them directly at +91-7404557227, or send an email to [email protected].
For a more comprehensive understanding of the MD9 license needed to manufacture the Brain-responsive electrical stimulation system in India, you can also read this article.