- Published on
CDSCO Manufacturing License for Laser lithotripsy fibre/suction guide
- Authors
- Name
- CDSCO Licenses Blog
Introduction
The Central Drugs Standard Control Organization (CDSCO) is one of the key healthcare organizations in India, in charge of assessing the safety, quality, and efficiency of drugs and medical devices. Understanding and acquiring CDSCO manufacturing licenses is a vital step for medical device manufacturers to ensure their products category receive due regulatory authorization and are fit for market distribution.
In this context, we will be exploring the Laser lithotripsy fibre/suction guide, an essential medical device, important in nephrology and renal care. You can access the CDSCO's portal here.
<TOCInline toc={props.toc} exclude='Introduction' />
What is Laser lithium cytometry fibre/suction guide?
The Laser Lithotripsy Fibre/Suction Guide is classified as a surgical device intended for insertion of the laser fibre of a laser beam guide in a nephroscope. It is also used for the removal of debris (e.g., fluid, calculus fragments) when connected to a vacuum source and plays a pivotal role in aiding procedures related to nephrology and renal care.
The Role of CDSCO in Medical Device Regulation
CDSCO serves as the national regulatory authority for pharmaceuticals and medical devices, working tirelessly to ensure the safety, efficacy, and quality of these products. Their regulatory framework for medical devices classifies them into four risk classes - Class A, B, C, and D. The Laser Lithotripsy Fibre/Suction Guide falls under Class B.
How to manufacture Laser lithotripsy fibre/suction guide
Manufacturing the Laser lithotripsy fibre/suction guide involves following stringent regulatory guidelines and ensuring adherence to manufacturing best practices. Given its classification under Class B, the manufacturing process must comply with the regulatory requirements of CDSCO.
Fees for manufacturing license for Laser lithotripsy fibre/suction guide
Since the Laser lithotripsy fibre is classified as a Class B medical device, the license fee falls under MD5, which requires Rs. 5,000 for the license and Rs. 500 per product.
Why is a Manufacturing License Necessary for Laser lithotripsy fibre/suction guide
Acquiring a manufacturing license for Class B medical devices like the Laser lithotripsy fibre/suction guide is mandatory. Having a license ensures quality and safety in the process of medical device production and compliance with regulatory standards. It serves as a protective measure against the circulation of substandard products, safeguarding consumer health and trust.
Steps to Obtain a CDSCO Manufacturing License for Laser lithotripsy fibre/suction guide
Obtaining CDSCO's manufacturing license requires careful preparation and compliance. Needed prerequisites include Device Master File, Quality Management Certificate, Device Details, Site details, among others. The application process consists of submission to approval, with the potential for challenges that require strategic responses. Learn more about the process of the MD5 license here.
Frequently Asked Questions (FAQs)
Q. What is the risk class of Laser Lithotripsy Fibre/Suction Guide as per Medical Device Rules, 2017? A. The Laser Lithotripsy Fibre/Suction Guide is categorised under risk Class B.
Q. What license in needed to manufacture Laser Lithotripsy Fibre/Suction Guide? A. The device needs the MD5 license for its manufacture.
Q. What is the fee for the MD5 license for Laser lithotripsy fibre/suction guide? A. The fees for the MD5 license are Rs. 5,000 and an additional Rs. 500 per product.
Q. Who will issue a manufacturing license for Laser Lithotripsy Fibre/Suction Guide? A. For Class B devices like the Laser Lithotripsy Fibre/Suction Guide, the license will be issued by the state FDA.
Q. Is repackaging of Laser Lithotripsy Fibre/Suction Guide considered manufacturing? A. Yes, under the Drugs and Cosmetics Act's definition of manufacturing, repackaging of medical devices (including the Laser Lithotripsy Fibre/Suction Guide) is considered manufacturing, requiring an MD5 license.
Conclusion
The journey to obtaining your CDSCO manufacturing license might seem difficult, but scientific experts and consultants like Pharmadocx Consultants are here to lend a helping hand throughout the process. Get in touch via phone "+91-7404557227", or reach us by email at [email protected].
