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CDSCO Manufacturing License for Intramuscular diaphragm/phreni c nerve electrical stimulation system
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Introduction
The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. Its primary responsibilities include ensuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices imported, sold, or manufactured in India. CDSCO plays an essential role in the medical device industry by issuing manufacturing licenses, thereby guaranteeing quality and safety.
One such critical medical device is the Intramuscular Diaphragm/Phrenic Nerve Electrical Stimulation System. Considering its significant role in providing ventilatory support to patients with diaphragm dysfunction, a manufacturing license from CDSCO holds substantial importance.
CDSCO's portal #https://cdscomdonline.gov.in/NewMedDev/Homepage offers accessible information about medical device regulations and licensing procedures.
- What is Intramuscular Diaphragm/Phrenic Nerve Electrical Stimulation System?
- The Role of CDSCO in Medical Device Regulation
- How to Manufacture Intramuscular Diaphragm/Phrenic Nerve Electrical Stimulation System
- Fees for Manufacturing License for Intramuscular Diaphragm/Phrenic Nerve Electrical Stimulation System
- Why is a Manufacturing License Necessary for Intramuscular Diaphragm/Phrenic Nerve Electrical Stimulation System?
- Steps to Obtain a CDSCO Manufacturing License for Intramuscular Diaphragm/Phrenic Nerve Electrical Stimulation System
- Frequently Asked Questions (FAQs)
- Conclusion
What is Intramuscular Diaphragm/Phrenic Nerve Electrical Stimulation System?
This system is a medical device used to support patients with diaphragm dysfunction of neuromuscular origin. It works by electrically stimulating the phrenic nerve to contract the diaphragm rhythmically through intramuscular electrodes. Thus, it facilitates the patient to draw breath in a manner similar to natural breathing.
The Role of CDSCO in Medical Device Regulation
With a mission aimed at safeguarding and enhancing public health in the country, CDSCO plays an essential role in regulating medical devices. Its regulatory framework for medical devices carefully categorizes devices into four risk classes – A, B, C, and D, with D being the highest risk and requiring maximum scrutiny and regulation.
How to Manufacture Intramuscular Diaphragm/Phrenic Nerve Electrical Stimulation System
The manufacturing of this device strictly requires adhering to the regulations laid down by the CDSCO and the procurement of an MD9 license given its classification as class D.
Fees for Manufacturing License for Intramuscular Diaphragm/Phrenic Nerve Electrical Stimulation System
The fee for an MD9 license, as required for the production of a Class D device, is Rs. 50,000 for the license and Rs. 1,000 per product.
Why is a Manufacturing License Necessary for Intramuscular Diaphragm/Phrenic Nerve Electrical Stimulation System?
An manufacturing license is mandatory to assure the safety and quality of the device, as it directly affects the health and well-being of patients. Compliance with regulatory requirements is not only a legal necessity but also significant in protecting consumers from inferior products.
Steps to Obtain a CDSCO Manufacturing License for Intramuscular Diaphragm/Phrenic Nerve Electrical Stimulation System
Acquiring the manufacturing license involves certain pre-requisites including documentation such as Device Master File, Quality Management Certificate, Device Details, Site details, etc. The process includes submission to approval, with common challenges to overcome on the path.
Frequently Asked Questions (FAQs)
Q. What is the risk class of Intramuscular Diaphragm/Phrenic Nerve Electrical Stimulation System as per Medical Device Rules, 2017?
A. As per the Medical Device Rules, 2017, Intramuscular Diaphragm/Phrenic Nerve Electrical Stimulation System fall into the Class D risk category.
Q. What license is needed to manufacture Intramuscular Diaphragm/Phrenic Nerve Electrical Stimulation System?
A. To manufacture this device, an MD9 license is needed.
Q. What is the fees for MD9 license for Intramuscular Diaphragm/Phrenic Nerve Electrical Stimulation System?
A. The fee for MD9 license is Rs. 50,000 for the license and Rs. 1,000 per product.
Q. Who will issue manufacturing license for Intramuscular Diaphragm/Phrenic Nerve Electrical Stimulation System?
A. For class C & D devices, including this system, the CDSCO HQ in New Delhi will issue the license.
Q. Is repackaging of Intramuscular Diaphragm/Phrenic Nerve Electrical Stimulation System considered manufacturing?
A. Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. With medical devices also considered as drugs under this Act, repackaging of Intramuscular Diaphragm/Phrenic Nerve Electrical Stimulation System is also viewed as manufacturing needing an MD9 license.
Conclusion
For further information on the licensing procedures or assistance in navigating the regulatory hurdles, we encourage readers to reach out to Pharmadocx Consultants at #https://www.pharmadocx.com, call +91-7404557227 or email to [email protected]. For comprehensive details on MD9 licensing, please check this #article. Quality and regulatory compliance play a critical role in healthcare; partnering with experts could make your journey easier and more successful.
