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CDSCO Manufacturing License for Ejaculation electrical stimulation system
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Introduction
The Central Drugs Standard Control Organization (CDSCO) plays a vital function in India's medical industry, ensuring that medications and medical devices meet crucial standards of safety, efficacy and quality. It is responsible not only for approving new drugs and devices but also for monitoring the market for any contraventions of standards. CDSCO's role is essential for the smooth functioning of India’s healthcare industry, underpinning trust in the effectiveness and safety of medical treatments.
Manufacturing licenses play a significant role in the medical device industry as they serve to maintain rigorous standards in an industry where the stakes are particularly high. Ensuring patient safety and the overall quality of healthcare is crucial, and this cannot be done without proper regulation in place. One such eminent medical device is the Ejaculation electrical stimulation system, the manufacturing and use of which is overseen by CDSCO.
Navigate to CDSCO's portal by following the link here: CDSCO Portal
- What is Ejaculation electrical stimulation system?
- The Role of CDSCO in Medical Device Regulation
- How to manufacture Ejaculation electrical stimulation system
- Fees for manufacturing license for Ejaculation electrical stimulation system
- Why is a Manufacturing License Necessary for Ejaculation electrical stimulation system?
- Steps to Obtain a CDSCO Manufacturing License for Ejaculation electrical stimulation system
- Frequently Asked Questions (FAQs)
- Conclusion
What is Ejaculation electrical stimulation system?
This particular piece of medical equipment is a device used to apply electrical stimuli to the nerves that control ejaculation. It plays a critical role in treating conditions related to ejaculation dysfunction and has seen extensive use in the medical field.
Common procedures involving the Ejaculation electrical stimulation system include treatments for ejaculation-related conditions such as premature ejaculation, erectile dysfunction etc. The device measures activity in the ejaculation-activating nerves and delivers the required signals to stimulate or control the process.
The Role of CDSCO in Medical Device Regulation
As the national regulatory body for pharmaceuticals and medical devices in India, CDSCO ensures that the devices available in the market are safe and effective. It provides a comprehensive regulatory framework for medical devices, encompassing everything from licensing and quality control to market surveillance.
How to manufacture Ejaculation electrical stimulation system
In order to manufacture an Ejaculation electrical stimulation system, appropriate licenses as per the guidelines of CDSCO must be obtained.
Fees for manufacturing license for Ejaculation electrical stimulation system
The Ejaculation electrical stimulation system is a Class C medical device thus requires an MD9 license. The fee for an MD9 license is Rs. 50,000 and an additional fee of Rs. 1,000 per product.
Why is a Manufacturing License Necessary for Ejaculation electrical stimulation system?
Manufacturing licenses are compulsory under the CDSCO regulations. They play a critical role in maintaining quality and safety in the production of medical devices. Further, they uphold the importance of regulatory compliance in the healthcare sector and protect consumers and patients from substandard products.
Steps to Obtain a CDSCO Manufacturing License for Ejaculation electrical stimulation system
- Prepare the Device Master File, Quality Management Certificate, Device Details, Site details etc.
- Submit the application with required documentation.
- Await the evaluation process and possible requirements for modifications or further documentation.
- On approval, the license will be issued by the CDSCO HQ in New Delhi.
Frequently Asked Questions (FAQs)
Q: What is the risk class of Ejaculation electrical stimulation system as per Medical Device Rules, 2017? A: The Ejaculation electrical stimulation system is classified as a Class C device.
Q: What license in needed to manufacture Ejaculation electrical stimulation system? A: An MD9 license is required to manufacture an Ejaculation electrical stimulation system.
Q: What is the fee for an MD9 license for Ejaculation electrical stimulation system? A: The fee for an MD9 license is Rs. 50,000, with an additional charge of Rs. 1,000 per product.
Q: Who will issue the manufacturing license for Ejaculation electrical stimulation system? A: The MD9 license will be issued by the CDSCO HQ in New Delhi.
Q: Is repackaging of Ejaculation electrical stimulation system considered manufacturing? A: Yes, as per the 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 the Drug Act only and hence repackaging of Ejaculation electrical stimulation system is also considered manufacturing requiring an MD9 license.
Conclusion
For further guidance or assistance on the process or if you have any questions, feel free to reach out to Pharmadocx Consultants at pharmadocx.com, call us at "+91-7404557227", or email "[email protected]". An active link is also provided for more information on the MD9 License MD9 License. We are more than happy to consult and facilitate the licensing process.
