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

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Introduction

Central Drugs Standard Control Organization(CDSCO) plays a commendable role in India's healthcare system. Acting as the national regulatory body for Indian pharmaceuticals and medical devices, it ensures patient safety by closely monitoring medicinal safety updates from across the world. Besides, it conducts post-marketing surveillance while ensuring that medical devices manufactured in, or exported to, India meet the necessary standards of quality, safety, and effectiveness.

In the complex sphere of medical devices, acquiring a manufacturing license is pivotal for manufacturers. It grants them legal authorization to process and market medical devices, thus ensuring regulatory compliance and safeguarding public health. Manufacturing licenses are a stamp of assurance for every medical device, including the Gait-enhancement electrical stimulation system, implantable (hereafter referred to as GEES), which this article will delve into.

The GEES is a vital medical device used for patients experiencing partial paralysis of the lower extremities or suffering from other neuromuscular disorders. To know more about the CDSCO and its plethora of contributions, kindly visit the official portal here.

What is Gait-Enhancement Electrical Stimulation System (GEES)?

Aimed at improving patients' gait who suffer from partial lower-extremity paralysis or other neuromuscular disorders, the Gait-Enhancement Electrical Stimulation System (GEES) is an implantable medical device which performs through internal electrical stimulation. This noteworthy device facilitates an individual's mobility by assisting in muscle control and balance, thereby significantly enhancing their quality of life.

Common uses of the GEES include aiding in muscle re-education, stopping muscle atrophy, fostering blood flow, and enhancing strength training.

The Role of CDSCO in Medical Device Regulation

CDSCO, the apex body governing India's drug standards and regulations, has been critical in shaping the country's medical devices sector. Founded under the aegis of the Ministry of Health and Family Welfare, its mission is to protect and promote public health.

In the realm of medical devices, CDSCO is responsible for approving and regulating new medical devices, ensuring they meet necessary safety and performance requirements. Licenses for medical device manufacturing fall under the oversight of CDSCO— a critical step in guaranteeing quality and performance of devices like GEES.

How to manufacture Gait-Enhancement Electrical Stimulation System (GEES)

Manufacturing a Gait-Enhancement Electrical Stimulation System (GEES) requires precise engineering and thorough quality control. The fabrication process involves sophisticated technology, inferential regulations, and standard protocols. Research, trials, and stringent testing are part of the manufacturing life cycle, ensuring these Class D devices adhere to the highest standard of safety and effectiveness.

Fees for manufacturing license for Gait-Enhancement Electrical Stimulation System (GEES)

Being a Class D device, the manufacturing license required for a GEES is MD9. The fees for an MD9 license are Rs. 50,000, with a per product charge of Rs. 1,000. To get more detailed information on the MD9 license, please refer to this comprehensive guide.

Why is a Manufacturing License Necessary for Gait-Enhancement Electrical Stimulation System (GEES)?

Obtaining a manufacturing license is mandatory for all medical devices, including the GEES. Ensuring quality and safety in medical device production is of utmost priority and mandates regulatory compliance in the healthcare sector. It serves as a necessary step in protecting consumers and patients from substandard or unsafe products. Hence, a CDSCO issued license guarantees that the manufactured GEES complies with all regulatory compliance and safety protocols.

Steps to Obtain a CDSCO Manufacturing License for Gait-Enhancement Electrical Stimulation System (GEES)

  1. Prepare required documents like Device Master File, Quality Management Certificate, Device Details, Site Details, etc.

  2. Submit the application through CDSCO's online portal.

  3. Await approval which typically can take a certain number of weeks.

  4. Navigating through common challenges encountered in the process by utilizing the right resources and guidance.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Gait-Enhancement Electrical Stimulation System (GEES) as per Medical Device Rules, 2017?

Answer: GEES falls under Class D as per Medical Device Rules, 2017.

Q2. What license is needed to manufacture Gait-Enhancement Electrical Stimulation System (GEES)?

Answer: To manufacture GEES, an MD9 license is necessary.

Q3. What is the fee for an MD9 license for Gait-Enhancement Electrical Stimulation System (GEES)?

Answer: The license fee for MD9 is Rs. 50,000 with an additional Rs. 1,000 per product charge.

Q4. Who will issue the manufacturing license for Gait-Enhancement Electrical Stimulation System (GEES)?

Answer: For Class D devices like GEES, the CDSCO HQ in New Delhi will issue the manufacturing license.

Q5. Is repackaging of Gait-Enhancement Electrical Stimulation System (GEES) considered manufacturing?

Answer: Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. Thus, since medical devices are also classified as drugs, the repackaging of Gait-Enhancement Electrical Stimulation System (GEES) is considered manufacturing and hence requires an MD9 license.

Conclusion

The process of obtaining manufacturing licenses for medical devices can be complex and daunting without proper guidance. Seek expert consultation or assistance regarding the licensing process. Reach out to the Pharmadocx Consultants either through their website "here", call on "+91-7404557227" or via email at "[email protected]". Navigate through the complexities of the licensing process with assured, professional help and secure your manufacturing license effectively.

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