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CDSCO Manufacturing License for Neurological stereotactic surgery system
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- CDSCO Licenses Blog
Introduction
The Central Drugs Standard Control Organization (CDSCO) is India's forefront in healthcare and plays a pivotal role in safeguarding public health. Its responsibilities include laying down various standards for drugs and cosmetics, controlling quality, and overseeing the legislation about these. Manufacturing licenses are absolutely indispensable in the medical device industry and need to be adhered to strictly to ensure patient safety and product efficacy.
One such medical device that requires a manufacturing license in line with CDSCO's regulations is the Neurological stereotactic surgery system. This invaluable tool allows healthcare professionals to conduct image-guided neurosurgeries accurately. You can learn more about this and other licensing specifics at the CDSCO's portal.
- What is Neurological stereotactic surgery system?
- The Role of CDSCO in Medical Device Regulation
- How to Manufacture Neurological Stereotactic Surgery System
- Fees for Manufacturing License for Neurological Stereotactic Surgery System
- Why is Manufacturing License Necessary for Neurological Stereotactic Surgery System
- Steps to Obtain a CDSCO Manufacturing License for Neurological Stereotactic Surgery System
- Frequently Asked Questions (FAQs)
- Conclusion
What is Neurological stereotactic surgery system?
The Neurological stereotactic surgery system is a computer-assisted apparatus used to conduct critical brain surgeries. It leverages three-dimensional coordinates to pinpoint specific areas of the brain, making operations more precise and effective. This system is commonly used in neurosurgeries where treatment needs to be focused on a particular area without damaging the surrounding areas.
The Role of CDSCO in Medical Device Regulation
Since its inception, CDSCO has been entrusted with the crucial job of regulating medical devices and drugs in the country. This organization lays out a comprehensive framework for overseeing this process, which involves choreographing trials, approving drugs and medical devices, overseeing their quality and safety, among other tasks.
How to Manufacture Neurological Stereotactic Surgery System
Manufacturing the Neurological stereotactic surgery system involves following strict regulations by adhering to the guidelines laid by CDSCO. This includes obtaining necessary permissions and licenses and following the recommended procedures to guarantee the device's safety and functionality.
Fees for Manufacturing License for Neurological Stereotactic Surgery System
As it falls under the class C medical devices, the license required for manufacturing the Neurological stereotactic surgery system is MD9. The fee for this license is Rs. 50,000, and an additional Rs. 1,000 per product is charged. Learn more about the MD9 license here.
Why is Manufacturing License Necessary for Neurological Stereotactic Surgery System
A manufacturing license is not just a legality, rather it has a crucial role to play in the medical industry. It ensures uniformity in production, confirms the quality and safety of devices, and is a mark of compliance. Furthermore, it also protects the patients from potential harm of substandard products.
Steps to Obtain a CDSCO Manufacturing License for Neurological Stereotactic Surgery System
The process of acquiring a manufacturing license involves:
- Fulfilling all prerequisites and ensuring all required documentation, including Device Master File, Quality Management Certificate, Device Details, Site details, etc., is complete.
- Submitting the application
- Waiting for the approval process
- Overcoming common challenges with careful guidance and perseverance
Frequently Asked Questions (FAQs)
Q1: What is the risk class of Neurological stereotactic surgery system as per Medical Device Rules, 2017?
A: Neurological stereotactic surgery system is classified as a Class C medical device.
Q2: What license is needed to manufacture Neurological stereotactic surgery system?
A: A MD9 license is required to manufacture Neurological stereotactic surgery system.
Q3: What is the fee for MD9 license for Neurological stereotactic surgery system?
A: The fee for a MD9 license is Rs. 50,000 plus Rs. 1,000 per product.
Q4: Who will issue the manufacturing license for Neurological stereotactic surgery system?
A: For class C medical devices like Neurological stereotactic surgery system, the CDSCO HQ in New Delhi will issue the license.
Q5: Is repackaging of Neurological stereotactic surgery system considered manufacturing?
A: Yes, as per Drugs and Cosmetics Act's definition of manufacturing, which includes repackaging, thus repackaging of Neurological stereotactic surgery system is also considered as manufacturing. Medical Device Rules have been made under the provisions of Drug Act only and hence repackaging of Neurological stereotactic surgery system requires a license on MD9.
Conclusion
Navigating the world of medical device licensing can be complex and often overwhelming. For reliable guidance and consultation, you can reach out to the experienced team at Pharmadocx Consultants. Feel free to call us at +91-7404557227 or email us at [email protected] for more information. Be sure to check-up on the licensing needs regularly and understand the gravity of following the regulations laid by organizations like CDSCO!
