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CDSCO Manufacturing License for Bladder-emptying vibratory stimulator
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Introduction
The Central Drugs Standard Control Organization (CDSCO) plays a vital role in safeguarding and promoting public health in India. It is the apex body for regulating pharmaceuticals and medical devices in the country. One of the critical responsibilities of CDSCO is the regulation, supervision, and approval of the manufacture of medical devices, ensuring they meet set standards for safety and effectiveness. In the field of medical technology, the manufacturing of devices like the Bladder-emptying vibratory stimulator has revolutionized health care practices. This medical device is of paramount importance in the sector of rehabilitation. Navigate the CDSCO's portal here for more information.
- What is a Bladder-emptying vibratory stimulator?
- The Role of CDSCO in Medical Device Regulation
- How to Manufacture a Bladder-emptying vibratory stimulator
- Fees for manufacturing license for Bladder-emptying vibratory stimulator
- Why is a Manufacturing License Necessary for a Bladder-emptying vibratory stimulator?
- Steps to Obtain a CDSCO Manufacturing License for a Bladder-emptying vibratory stimulator
- Frequently Asked Questions (FAQs)
- Conclusion
What is a Bladder-emptying vibratory stimulator?
A Bladder-emptying vibratory stimulator is a medically designed device that is intended to initiate urination and facilitate complete bladder emptying. It works by applying small mechanical vibrations to the lower abdomen, promoting urethral sphincter relaxation. This device has brought about a breakthrough in the medical field, particularly in the areas of urology and rehabilitation.
The Role of CDSCO in Medical Device Regulation
Established with a mission to safeguard and enhance public health in India, CDSCO has curated an effective regulatory framework for medical devices. With its commitment to ensuring high-quality standards for pharmaceuticals and medical devices, it has progressively shaped the sector's growth and innovation.
How to Manufacture a Bladder-emptying vibratory stimulator
With proper licensing, the manufacturing process of a Bladder-emptying vibratory stimulator is governed by set regulations to ensure quality and safety. The license required for manufacturing this class B device is MD5.
Fees for manufacturing license for Bladder-emptying vibratory stimulator
The fee for an MD5 license is Rs. 5,000, with an additional charge of Rs. 500 per product.
Why is a Manufacturing License Necessary for a Bladder-emptying vibratory stimulator?
Obtaining a manufacturing license is not just a formal requirement; it is a commitment to quality, safety, and reliability. By ensuring regulatory compliance, we safeguard patients from substandard products and uphold the integrity and trust in the products.
Steps to Obtain a CDSCO Manufacturing License for a Bladder-emptying vibratory stimulator
The licensing process involves the submission of Device Master File, Quality Management Certificate, Device Details, Site details, etc. Challenges may arise, but with appropriate guidance, they can be swiftly addressed and resolved.
Frequently Asked Questions (FAQs)
Q. What is the risk class of a Bladder-emptying vibratory stimulator as per the Medical Device Rules, 2017?
A. The Bladder-emptying vibratory stimulator has been categorized as a risk class B device.
Q. What license is needed to manufacture a Bladder-emptying vibratory stimulator?
A. An MD5 license is needed to manufacture a Bladder-emptying vibratory stimulator.
Q. What is the fee for an MD5 license for a Bladder-emptying vibratory stimulator?
A. The fee for an MD5 license is Rs. 5,000, excluding the product fee of Rs. 500 per product.
Q. Who will issue the manufacturing license for a Bladder-emptying vibratory stimulator?
A. For Class B devices like Bladder-emptying vibratory stimulator, the state FDA will issue the license.
Q. Is repackaging of a Bladder-emptying vibratory stimulator considered manufacturing?
A. Yes, repackaging of a Bladder-emptying vibratory stimulator is treated as manufacturing. Hence, it requires an MD5 license.
Conclusion
Navigating the licensing process can be challenging but essential for ensuring the safety and quality of medical devices. For expert consultation or assistance regarding the licensing process, you are encouraged to reach out to Pharmadocx Consultants or call +91-7404557227 or email at [email protected]. Also, delve deeper into the licensing process by understanding MD5 by reading here.
