CDSCO Manufacturing License for Interferential electrical stimulation system

Introduction

The Central Drugs Standard Control Organization (CDSCO) is the chief regulatory body in India that ensures safety, efficacy, and quality of medical devices and drugs. CDSCO plays a vital role in safeguarding public health by ensuring regulatory approval of drugs and medical devices, creating standards, and conducting pre and post-market surveillance. An essential aspect of this regulatory framework is manufacturing licenses for the medical devices industry.

Today, we shed light on a remarkable medical device named the Interferential Electrical Stimulation System. Notably, this device revolutionizes the way we approach nerve stimulation and rehabilitation therapy. For instant access to information on CDSCO, please visit https://cdscomdonline.gov.in/NewMedDev/Homepage

• What is Interferential Electrical Stimulation System?
• The Role of CDSCO in Medical Device Regulation
• How to Manufacture Interferential Electrical Stimulation System
• Fees for Manufacturing License for Interferential Electrical Stimulation System
• Why is a Manufacturing License Necessary for Interferential Electrical Stimulation System?
• Steps to Obtain a CDSCO Manufacturing License for Interferential Electrical Stimulation System
• Frequently Asked Questions (FAQs)
• Conclusion

What is Interferential Electrical Stimulation System?

The Interferential Electrical Stimulation System is a medical device used to stimulate peripheral nerves. It works through the transcutaneous application of two currents with slightly different frequencies. These currents interfere or crossover, thereby creating a beating frequency at the treatment point. The device has found considerable use in physiotherapy and nerve rehabilitation procedures.

The Role of CDSCO in Medical Device Regulation

The mission of CDSCO extends beyond their initial role as a watchdog for drug standardization. Over the years, the organization has taken on the mantle of regulating the diverse landscape medical devices. An overview of their regulatory control for medical devices showcases their contribution in ensuring standards, safety, and efficacy, making them a cornerstone of the healthcare sector.

How to Manufacture Interferential Electrical Stimulation System

The manufacturing process of Interferential Electrical Stimulation Systems requires intricate knowledge of electrical and biomedical engineering. Once the device is designed and produced, it must go through a rigorous testing phase to ensure functionality and safety, conforming to the guidelines set by CDSCO.

Fees for Manufacturing License for Interferential Electrical Stimulation System

As it falls in the Class C category, manufacturing the Interferential Electrical Stimulation System requires an MD9 license. The cost for this license is Rs. 50,000, along with Rs. 1,000 per product.

Why is a Manufacturing License Necessary for Interferential Electrical Stimulation System?

The manufacturing license for Interferential Electrical Stimulation Systems is mandatory. The significance of this licensing extends beyond mere legalities. It is instrumental in ensuring quality and safety in medical device production, reinforcing regulatory compliance in the healthcare sector, and protecting consumers and patients from substandard products.

Steps to Obtain a CDSCO Manufacturing License for Interferential Electrical Stimulation System

1. Prepare necessary documentation such as Device Master File, Quality Management Certificate, Device Details, Site details.
2. Submit the application to CDSCO or state FDA, as per the risk class of the device.
3. The application will then go through a rigorous review process before approval.
4. Overcome common challenges in license acquisition by consulting experts and ensuring proper documentation.

Frequently Asked Questions (FAQs)

1. What is risk class of Interferential Electrical Stimulation System as per Medical Device Rules, 2017?
   The Interferential Electrical Stimulation System falls into Risk Class C.
2. What license is needed to manufacture Interferential Electrical Stimulation System?
   The MD9 license is required for manufacturing the Interferential Electrical Stimulation System.
3. What is fees for MD9 license for Interferential Electrical Stimulation System?
   The fee for the MD9 license for the Interferential Electrical Stimulation System is Rs. 50,000 for the license and Rs. 1,000 per product.
4. Who will issue manufacturing license for Interferential Electrical Stimulation System?
   For Class C devices such as this, the CDSCO HQ in New Delhi will issue the license.
5. Is repackaging of Interferential Electrical Stimulation System considered manufacturing?
   Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. Similarly, medical devices are also considered as drugs. Therefore, repackaging of Interferential Electrical Stimulation System is also considered manufacturing, hence requiring an MD9 license.

Conclusion

Navigating the complex landscape of CDSCO regulations and licensing can be challenging. Professionals and interested parties are encouraged to seek consultation or assistance regarding the process. For more details, you can reach out to Pharmadocx Consultants at "+91-7404557227" or email at [email protected]. You can also refer to this detailed article on obtaining the MD9 manufacturing license to learn more.