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CDSCO Manufacturing License for Implantable incontinence- control electrical stimulation system
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Introduction
The Central Drugs Standard Control Organization (CDSCO) is a prominent drug regulating authority in India, playing a vital role in safeguarding and promoting public health in the country. The CDSCO is primarily responsible for implementing the Drugs and Cosmetics Act, 1940 and Rules 1945, ensuring that medical devices destined for usage within India are safe, effective and of quality assurance.
In the medical devices industry, manufacturing licenses hold an essential aspect in maintaining industrial kindred and fastidious quality control. The manufacturers of Implantable incontinence- control electrical stimulation system, a remarkable medical device used for treating lower urinary tract disorders, are required to procure these licenses to ensure their product's quality and safety.
For more details, feel free to visit the CDSCO's portal here.
- What is Implantable Incontinence-Control Electrical Stimulation System?
- The Role of CDSCO in Medical Device Regulation
- How to Manufacture Implantable Incontinence-Control Electrical Stimulation System
- Fees for manufacturing license for Implantable Incontinence-Control Electrical Stimulation System
- Why is a Manufacturing License Necessary for Implantable Incontinence-Control Electrical Stimulation System?
- Steps to Obtain a CDSCO Manufacturing License for Implantable Incontinence-Control Electrical Stimulation System
- Frequently Asked Questions (FAQs)
- Conclusion
What is Implantable Incontinence-Control Electrical Stimulation System?
The Implantable incontinence-control electrical stimulation system is essentially an assembly of battery-powered medical devices. The primary purpose of this device is to treat chronic disorders of the pelvis and lower urinary or intestinal tract often associated with urinary and/or fecal incontinence, through the application of electrical stimuli. The device plays a crucial role in treating patients suffering from urinary continence, hence underscoring its importance in the healthcare industry.
The Role of CDSCO in Medical Device Regulation
Given its noble purpose of protecting public health, the CDSCO regulates the medical devices industry under the comprehensive regulatory framework, ensuring that the devices produced are safe, effective, and of high quality.
How to Manufacture Implantable Incontinence-Control Electrical Stimulation System
The manufacturing of this device falls under the Class C risk category, hence it is crucial for manufacturers to adhere to stringent standards and regulations. This is to guarantee the safety and efficiency of the device, ensuring its significantly beneficial use in healthcare.
Fees for manufacturing license for Implantable Incontinence-Control Electrical Stimulation System
Given the Class C risk category, the device manufacturers require an MD9 license. The fee for MD9 license amounts to Rs. 50,000 and an additional Rs. 1,000 per product. More about MD9 License
Why is a Manufacturing License Necessary for Implantable Incontinence-Control Electrical Stimulation System?
Procuring a manufacturing license is mandatory for manufacturing this medical device. It ensures quality and safety in medical device production, promotes regulatory compliance in the healthcare sector, and protects consumers and patients from substandard products.
Steps to Obtain a CDSCO Manufacturing License for Implantable Incontinence-Control Electrical Stimulation System
To obtain a license, manufacturers need to provide essential documentation including Device Master File, Quality Management Certificate, Device Details, Site details, and others. The application process involves submission to approval, assessing the manufacturer's capability to produce high-quality devices. The CDSCO Headquarters in New Delhi will issue the license after all requirements are met.
Frequently Asked Questions (FAQs)
What is risk class of Implantable Incontinence-Control Electrical Stimulation System as per Medical Device Rules, 2017? The device falls under the Class C risk category.
What license is needed to manufacture Implantable Incontinence-Control Electrical Stimulation System? An MD9 license is required to manufacture this device.
What is the fee for MD9 license for the Implantable Incontinence-Control Electrical Stimulation System? The fee for MD9 license is Rs. 50,000 and an additional Rs. 1,000 per product.
Who will issue the manufacturing license for the Implantable Incontinence-Control Electrical Stimulation System? The CDSCO Headquarters in New Delhi will issue the license.
Is repackaging of the Implantable Incontinence-Control Electrical Stimulation System considered manufacturing? Yes, according to the Drug and Cosmetics Act's definition, repackaging of medical devices is considered manufacturing, thus requiring MD9 license.
Conclusion
Manufacturing licenses are integral for ensuring the safety and effectiveness of medical devices. If you require any assistance regarding the licensing process, do not hesitate to reach out to Pharmadocx Consultants, call on +91-7404557227, or email at [email protected]. We are here to ensure your journey towards obtaining a manufacturing license for medical devices is smooth and hassle-free.
