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CDSCO Manufacturing License for Cryogenic surgical device.
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Introduction
The Central Drugs Standard Control Organization (CDSCO) is the leading national regulatory authority in India. Its primary responsibility is safeguarding public health by regulating the quality and safety of drugs, vaccines and medical devices. While determining their efficacy, CDSCO ensures that these products are up to health standards. In the medical device industry, manufacturing licenses are of utmost importance; such a license signifies a guarantee that the medical device is safe, efficient and complies with the necessary health regulations.
One of such devices is the Cryogenic surgical device; a device having significant medical importance in the field of neurology. It’s a device used to destroy nervous tissue or produce lesions in nervous tissue by the application of extreme cold to the selected site. You can find more detailed and specific information about these devices and their licenses on the CDSCO's portal.
- What is a Cryogenic Surgical Device?
- The Role of CDSCO in Medical Device Regulation
- How to Manufacture Cryogenic Surgical Devices
- Fees for Manufacturing License for Cryogenic Surgical Devices
- Why is a Manufacturing License Necessary for a Cryogenic Surgical Device?
- Steps to Obtain a CDSCO Manufacturing License for a Cryogenic Surgical Device
- Frequently Asked Questions (FAQs)
- Conclusion
What is a Cryogenic Surgical Device?
A Cryogenic surgical device is an instrument used to destroy or disable nervous tissues by applying extreme cold temperatures. This technique, also known as cryosurgery, is a common practice in neurology and often used to treat conditions such as Parkinson's disease or epilepsy. Moreover, cryosurgery is less invasive and has shorter recovery time compared to other surgical methods.
The Role of CDSCO in Medical Device Regulation
The Central Drugs Standard Control Organization (CDSCO), under the guidance of the Ministry of Health & Family Welfare, is the chief regulatory body in India. Its primary role is to ensure that medical devices, drugs, and vaccines manufactured and sold in India meet the required health and safety standards. CDSCO's regulatory framework for medical devices is designed in compliance with the best international practices and norms.
How to Manufacture Cryogenic Surgical Devices
Manufacturing a cryogenic surgical device requires a high level of technological expertise, compliance with medical standards, and adherence to the regulatory framework set by CDSCO. Class D medical devices like the Cryogenic surgical device need the MD9 manufacturing license in accordance with the Indian medical device regulatory system.
Fees for Manufacturing License for Cryogenic Surgical Devices
Obtaining the MD9 license for manufacturing a Cryogenic surgical device costs Rs. 50,000 for the license and an additional Rs. 1,000 per product.
Why is a Manufacturing License Necessary for a Cryogenic Surgical Device?
Procuring a manufacturing license is compulsory for anyone intending to manufacture a Cryogenic surgical device or any other medical device. Licensing ensures that manufacturing processes adhere to quality and safety regulations. Regulatory compliance signifies a commitment to public health and safety and protects consumers from inferior and potentially dangerous products.
Steps to Obtain a CDSCO Manufacturing License for a Cryogenic Surgical Device
Obtaining a manufacturing license involves several steps. Initially, you need a Device Master File, Quality Management Certificate, details about the device, and the site. Then you need to apply for the license, undergo a review from the CDSCO, inspections, and eventually, the approval. Some common challenges include understanding and complying with the stringent regulations, which have been well addressed in this MD9 article.
Frequently Asked Questions (FAQs)
Q1. What is the risk class of a Cryogenic surgical device as per Medical Device Rules, 2017?
A Cryogenic Surgical Device falls under Risk Class D.
Q2. What license is needed to manufacture a Cryogenic surgical device?
To manufacture a Cryogenic surgical device, an MD9 manufacturing license is required.
Q3. What are the fees for an MD9 license for a Cryogenic surgical device?
The fee for an MD9 license for manufacturing a Cryogenic surgical device is Rs. 50,000 for the license and Rs. 1,000 per individual product.
Q4. Who will issue the manufacturing license for a Cryogenic surgical device?
For class C and D devices, such as the Cryogenic surgical device, the license is issued by the CDSCO headquarters in New Delhi.
Q5. Is repackaging of a Cryogenic surgical device considered manufacturing?
Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing and by extension, medical devices are also drugs. Medical Device Rules have been made under the provisions of Drug Act only and hence repackaging of a Cryogenic surgical device is also considered manufacturing requiring a license on MD9.
Conclusion
For any further queries or consultation about the licensing process for manufacturing a Cryogenic Surgical Device, feel free to get in touch with the team at Pharmadocx Consultants. You can reach out via a call on +91-7404557227 or email us at [email protected] for support.
