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CDSCO Manufacturing License for Cerebrospinal fluid manometer,
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Introduction
The Central Drugs Standard Control Organization (CDSCO) is India's primary regulatory body for pharmaceuticals and medical devices. Their chief objective is to ensure the quality and safety of products for consumers through regulation and licensing. Within the medical device industry, obtaining a manufacturing license is indispensable for the production and circulation of devices.
Today, we delve into the specifics of the Cerebrospinal fluid manometer, a crucial medical device used often in the healthcare field. This exploration includes an understanding of the relevant CDSCO regulations and the process of acquiring a manufacturing license for the device. Please click here to visit the official CDSCO portal.
- What is a Cerebrospinal fluid manometer?
- The Role of CDSCO in Medical Device Regulation
- How to Manufacture a Cerebrospinal fluid manometer
- Fees for Manufacturing License for a Cerebrospinal fluid manometer
- Why is a Manufacturing License Necessary for a Cerebrospinal fluid manometer?
- Steps to Obtain a CDSCO Manufacturing License for a Cerebrospinal fluid manometer
- Frequently Asked Questions (FAQs)
- Conclusion
What is a Cerebrospinal fluid manometer?
A cerebrospinal fluid (CSF) manometer is a specialized medical device designed to measure cerebrospinal fluid or intracranial pressure via lumbar puncture. The device is integral to detect and diagnose severe neurological conditions, such as hydrocephalus and meningitis.
The Role of CDSCO in Medical Device Regulation
The CDSCO, being the apex regulatory authority, formulates and implements policies for medical device regulation. Their mission includes protecting the public health in India by assuring the safety, efficacy and quality of medical devices. The regulatory framework incorporates risk-based evaluation, taking risk class and intended use of devices into account.
How to Manufacture a Cerebrospinal fluid manometer
Getting licensed for manufacturing a Class C medical device such as a cerebrospinal fluid manometer requires compliance with the regulations of CDSCO. Like other Class C devices, this, too, requires an MD9 manufacturing license.
Fees for Manufacturing License for a Cerebrospinal fluid manometer
To acquire the MD9 license for a Class C medical device like the cerebrospinal fluid manometer, a fee of Rs. 50,000 for the license and an additional Rs. 1,000 per product is required.
Why is a Manufacturing License Necessary for a Cerebrospinal fluid manometer?
Obtaining the necessary licenses for manufacturing are obligatory, but their importance extends beyond legal compliance. They ensure quality, safety, and performance in medical device production, which consequently reduces health risks for patients. Moreover, the process also helps in eliminating substandard products circulating in the market, thereby protecting consumers.
Steps to Obtain a CDSCO Manufacturing License for a Cerebrospinal fluid manometer
Following are the basic steps to obtain a manufacturing license for a Class C device:
- Preparation of pre-requisites such as Device Master File, Quality Management Certificate, Device Details, Site details, etc.
- Submitting the necessary documentation.
- Review of application by CDSCO.
- Receipt of approval and issuance of license.
Despite the straightforward process, challenges may arise, and seeking professional assistance can be beneficial.
Frequently Asked Questions (FAQs)
Q1. What is risk class of a Cerebrospinal fluid manometer as per Medical Device Rules, 2017? A1. A cerebrospinal fluid manometer falls under the risk class 'C'.
Q2. What license is needed to manufacture a Cerebrospinal fluid manometer? A2. An MD9 license is required to manufacture a cerebrospinal fluid manometer.
Q3. What is fees for MD9 license for a Cerebrospinal fluid manometer? A3. The fee for an MD9 license for a cerebrospinal fluid manometer is Rs 50,000 for the license and Rs 1,000 per product.
Q4. Who will issue manufacturing license for a Cerebrospinal fluid manometer? A4. For Class C devices such as a cerebrospinal fluid manometer, the manufacturing license will be issued by the CDSCO HQ in New Delhi.
Q5. Is repackaging of a Cerebrospinal fluid manometer considered manufacturing? A5. Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. Therefore, repackaging of a cerebrospinal fluid manometer is also regarded as manufacturing, necessitating an MD9 license.
For more information on MD9 Manufacturing License, please refer this article - MD9 Manufacturing License
Conclusion
Navigating the CDSCO regulations and licensing procedures may seem daunting, but it doesn't have to be. The team at Pharmadocx Consultants can provide comprehensive guidance and assistance throughout the process. We invite you to reach out on +91-7404557227, or via email at [email protected], for consultation or queries.