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CDSCO Manufacturing License for Pulsed signal therapy system
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- CDSCO Licenses Blog
Introduction
The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for pharmaceuticals and medical devices in India. It functions under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India. Primarily, the organization is responsible for approval of new drugs, clinical trials, laying down the standards for drugs, control over the quality of imported drugs and coordination of the activities of the State Drug Control Organization. It also deals with all matters relating to the secure and quality distribution and use of pharmaceuticals and medical devices.
Manufacturing licenses are extremely critical to maintain the standards and adhering to the guidelines in the medical device industry. Without these licenses, having quality medical devices for health care will be jeopardized. This blog shall focus on one particular medical device that is a pulsed signal therapy system. It is a key component in the health care systems, particularly in the field of Rehabilitation Medicine. You can find further details regarding this licensing process on the official portal CDSCO's portal.
- What is the Pulsed Signal Therapy System?
- The Role of CDSCO in Medical Device Regulation
- How to Manufacture the Pulsed Signal Therapy System
- Fees for the Manufacturing License for the Pulsed Signal Therapy System
- Why is a Manufacturing License Necessary for the Pulsed Signal Therapy System?
- Steps to Obtain a CDSCO Manufacturing License for the Pulsed Signal Therapy System
- Frequently Asked Questions (FAQs)
- Conclusion
What is the Pulsed Signal Therapy System?
A Pulsed Signal Therapy System is essentially a medical device that generates an electromagnetic field intended to stimulate body tissues. The primary purpose of this device is to regenerate damaged cartilage. This is achieved by stimulating the production of collagen types that are normally present in healthy cartilage. This medical device is commonly used in rehabilitation medicine and other treatments that require stimulation of tissue for healing and repair.
The Role of CDSCO in Medical Device Regulation
Since its inception, CDSCO has been chartering its mission to ensure the safety, efficacy, and quality of medical devices in India. This is achieved through a robust regulatory framework that includes the rigorous approval process of new devices, regulation of their manufacture, and their post-market surveillance. This framework includes the classifications of medical devices into four risk categories i.e Class A, B, C, and D, where Class A is the lowest and Class D is the highest risk category.
How to Manufacture the Pulsed Signal Therapy System
The manufacturing of the Pulsed Signal Therapy System requires a stringent procedure that is compliant with CDSCO regulations. This ensures the safety and efficacy of the devices produced, and as such, the necessary manufacturing license for such a device is MD9.
Fees for the Manufacturing License for the Pulsed Signal Therapy System
The cost for acquiring MD9 license for manufacturing Pulsed Signal Therapy System is Rs. 50,000 and an additional Rs. 1,000 per product.
Why is a Manufacturing License Necessary for the Pulsed Signal Therapy System?
Acquiring a manufacturing license for producing a Pulsed Signal Therapy System is mandatory. It ensures quality and safety in medical device production, which is the top priority in the healthcare sector. Apart from protecting consumers and patients from substandard products, being compliant with regulatory norms is also essential for manufacturers.
Steps to Obtain a CDSCO Manufacturing License for the Pulsed Signal Therapy System
The procedure for obtaining a MD9 license involves submitting the required documentation, like the Device Master File, Quality Management Certificate, Device Details, and Site details, etc to the CDSCO. After which follows the application review and approval process. Though the entire procedure can present certain common challenges, solutions are available to overcome them.
Frequently Asked Questions (FAQs)
Q. What is the risk class of Pulsed Signal Therapy System as per Medical Device Rules, 2017? A. The Pulsed Signal Therapy System falls under Risk Class C.
Q. What license is needed to manufacture the Pulsed Signal Therapy System? A. The MD9 license is needed for manufacturing the Pulsed Signal Therapy System.
Q. What is the fees for the MD9 license for the Pulsed Signal Therapy System? A. The cost for the MD9 license is Rs. 50,000 along with an additional Rs. 1,000 per product.
Q. Who will issue manufacturing license for the Pulsed Signal Therapy System? A. The CDSCO Headquarters in New Delhi will issue the manufacturing license for a Class C device like the Pulsed Signal Therapy System.
Q. Is repackaging of the Pulsed Signal Therapy System considered manufacturing? A. Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. Medical devices are also considered drugs as per this Act, hence repackaging of the Pulsed Signal Therapy System is also considered manufacturing that requires a MD9 license.
Conclusion
We encourage you to reach out to Pharmadocx Consultants if you need any consultation or assistance regarding the licensing process. You can also directly call on "+91-7404557227" or email to "[email protected]". For more on MD9 licensing, please check this article MD9 Licensing Article.
