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CDSCO Manufacturing License for Gait- enhancement electrical stimulation system, external

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Introduction

The Central Drugs Standard Control Organization (CDSCO) plays a vital role in the Indian healthcare sector, regulating the import, manufacture and distribution of drugs among other responsibilities. One of its key functions is the regulation of medical devices, ensuring quality and safety standards are met through the issuance of manufacturing licenses. In this article, our focus is on the Gait-enhancement electrical stimulation system, external – a groundbreaking device of paramount importance in the field of neurological disorders.

first step towards understanding the associated regulatory process, visit the CDSCO's portal.

What is the Gait-enhancement Electrical Stimulation System, External?

The Gait-enhancement Electrical Stimulation System, external is a medical device designed to enhance the gait of patients suffering from partial paralysis of the lower extremities or other neuromuscular disorders. This system functions by applying external electrical stimulation to the affected area, thereby improving motor function and coordination.

The Role of CDSCO in Medical Device Regulation

CDSCO has worked tirelessly to ensure the quality and safety of drugs and medical devices in India. CDSCO's regulatory framework for medical devices follows a risk-based approach, where devices are categorized into four classes based on the potential risk associated with their use.

How to Manufacture the Gait-enhancement Electrical Stimulation System, External

Manufacturing a medical device like the Gait-enhancement electrical stimulation system, external demands adherence to rigorous regulations, stringent quality standards and compliance to manufacturing practices.

Fees for Manufacturing License for Gait-enhancement Electrical Stimulation System, External

Given that the Gait-enhancement electrical stimulation system, external falls under class B risk category, it mandates a MD5 license for its manufacture. The fee for obtaining the MD5 license is Rs. 5,000 and Rs. 500 per product.

Why is a Manufacturing License Necessary for Gait-enhancement Electrical Stimulation System, External?

Obtaining a manufacturing license isn't an option, it's a necessity. It ensures that the manufacturing entity respects the quality and safety norms in medical device production. Regulatory compliance is quintessential in order to protect consumers and patients from substandard devices.

Steps to Obtain a CDSCO Manufacturing License for Gait-enhancement Electrical Stimulation System, External

Getting a manufacturing license involves some prerequisites. Necessary documentation includes Device Master File, Quality Management Certificate, Device Details, and Site details etc. The application process encompasses submission, scrutiny, rectification and approval. Training and experience undoubtedly help overcome common hurdles.

Frequently Asked Questions (FAQs)

Q.1 What is the risk class of Gait-enhancement Electrical Stimulation System, External as per Medical Device Rules, 2017?
A.1 Gait-enhancement Electrical Stimulation System, External falls under class B risk category as per Medical Device Rules, 2017.

Q.2 What license is needed to manufacture Gait-enhancement Electrical Stimulation System, External?
A.2 A MD5 license is required to manufacture Gait-enhancement Electrical Stimulation System, External.

Q.3 What is the fees for MD5 license for Gait-enhancement Electrical Stimulation System, External?
A.3 The fee for obtaining the MD5 license is Rs. 5,000 and Rs. 500 per product.

Q.4 Who will issue the manufacturing license for Gait-enhancement Electrical Stimulation System, External?
A.4 For Class A sterile and measuring & Class B devices like Gait-enhancement Electrical Stimulation System, External, the state FDA will issue the license.

Q.5 Is repackaging of Gait-enhancement Electrical Stimulation System, External considered manufacturing?
A.5 Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. As medical devices are also considered drugs, repackaging of Gait-enhancement Electrical Stimulation System, External is also considered manufacturing, requiring a MD5 license.

For more insight on MD5, follow the link.

Conclusion

In the dynamic landscape of medical devices, understanding and navigating through the regulatory requirements can be challenging. For expert consultation or assistance regarding the CDSCO Medical Devices Licensing process for Gait-enhancement Electrical Stimulation System, External, do reach out to Pharmadocx Consultants, or you can directly call at "+91-7404557227" or drop an email to "[email protected]".

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