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CDSCO Manufacturing License for Gastro-urological probe
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- CDSCO Licenses Blog
Introduction
The Central Drugs Standard Control Organization (CDSCO) is an integral part of India's healthcare system, playing an essential role in the regulation and licensing of medical devices in the country. CDSCO ensures that all medical devices manufactured and distributed in the country meet rigorous safety and efficacy standards. One such medical device that requires a manufacturing license is the Gastro-urological probe, which plays a pivotal role in gastroenterology procedures. The manufacturing license for this device ensures it is safe and effective for patient use. You can find more information on the CDSCO portal here.
- What is a Gastro-urological probe?
- The Role of CDSCO in Medical Device Regulation
- How to manufacture a Gastro-urological probe
- Fees for a manufacturing license for a Gastro-urological probe
- Why is a Manufacturing License Necessary for a Gastro-urological probe?
- Steps to Obtain a CDSCO Manufacturing License for a Gastro-urological probe
- Frequently Asked Questions (FAQs)
- Conclusion
What is a Gastro-urological probe?
A Gastro-urological probe is a slender, rod-like manual surgical instrument. Typically fashioned from flexible metal and fitted with a blunt bulbous tip, this device is designed for exploring gastroenterological/urological (GU) structures during a GU procedure. Its primary purpose is to assist healthcare professionals in diagnosing and treating issues that may arise within the gastro-urological sphere.
The Role of CDSCO in Medical Device Regulation
The Central Drugs Standard Control Organization (CDSCO) was established with the mission to protect and promote public health in India. A key mechanism for achieving this mission is the regulatory oversight of medical devices, with the Gastro-urological probe being no exception. CDSCO's regulatory framework for medical devices follows a risk-based approach, from Class A (lowest risk) to Class D (highest risk).
How to manufacture a Gastro-urological probe
Manufacturing a Gastro-urological probe in India requires strict adherence to the guidelines and regulations laid out by CDSCO.
Fees for a manufacturing license for a Gastro-urological probe
The Gastro-urological probe falls under class B of the risk classification, and therefore requires an MD5 license for manufacturing. The fees for an MD5 license are Rs. 5,000 for the license and Rs. 500 per product. For more information on the MD5 license, visit this link.
Why is a Manufacturing License Necessary for a Gastro-urological probe?
Obtaining a manufacturing license for a Gastro-urological probe is mandatory under Indian law. It signifies compliance with stringent medical device regulations, ensuring the quality and safety of the device. It also protects consumers from substandard products.
Steps to Obtain a CDSCO Manufacturing License for a Gastro-urological probe
Obtaining a CDSCO manufacturing license requires several prerequisite documents, including a Device Master File, Quality Management Certificate, device information, and site details. The four-step licensing process includes submitting an application to CDSCO, assessment of your application, responding to any queries, and finally, the approval of the license.
Frequently Asked Questions (FAQs)
Q: What is the risk class of a Gastro-urological probe as per Medical Device Rules, 2017?
A: The Gastro-urological probe is classified as a Class B medical device.
Q: What license is needed to manufacture a Gastro-urological probe?
A: Manufacturing a Gastro-urological probe in India requires an MD5 license.
Q: What is the fee for an MD5 license for a Gastro-urological probe?
A: The fees for an MD5 license are Rs. 5,000 for the license and Rs. 500 per product.
Q: Who will issue the manufacturing license for a Gastro-urological probe?
A: For Class B devices such as the Gastro-urological probe, the state FDA will issue the license.
Q: Is the repackaging of a Gastro-urological probe considered manufacturing?
A: Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. Therefore, the repackaging of a Gastro-urological probe also requires a license on MD5.
Conclusion
As complex as it might seem, navigating the licensing process can be made much simpler with the assistance of a trusted consultant. At Pharmadocx Consultants, we provide expert consultation services to guide you through every step. For more information, reach out to us at Pharmadocx Consultants, call us at +91-7404557227, or email us at [email protected]. We'll be more than happy to assist you with your journey towards compliance.
