CDSCO Manufacturing License for Power Knee

Introduction

The CDSCO (Central Drugs Standard Control Organization) of India is a pivotal organization in ensuring the safety, efficacy, and quality of drugs and medical devices in the country. Committed to public health and safety, the organization oversees all health care products' production, ensuring that only authorized and certifiable products make their way into the healthcare sector.

Manufacturing licenses play a pivotal role in the medical device industry as they certify the quality and safety of the products. They protect the consumers from substandard products and ensure high quality, efficient, and safe medical treatments.

Let's now shift our focus to a unique and innovative medical device named the Power Knee and its medical significance. Fast becoming an indispensable tool in the field of rehabilitation, the Power Knee enhances mobility, aids in daily activities, and significantly elevates the quality of life for amputees. Visit CDSCO's portal for comprehensive information about varied medical devices.

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What is Power Knee?

The Power Knee is an inventive motor-powered, microprocessor knee that serves an integral role in profound medical care. Designed with precision and technical brilliance, the Power Knee actively provides assistance during level-ground walking, climbing, and descending ramps or stairs and even when standing up. It is a boon in disguise for amputees, enabling them to maintain or regain their mobility and seamlessly participate in daily activities.

The Role of CDSCO in Medical Device Regulation

The Central Drugs Standard Control Organization plays a significant role in regulating the medical devices sector in India. The robust regulatory framework administered by the CDSCO ensures that all medical devices manufactured and sold in India adhere to strict guidelines pertaining to safety, ethics, and quality.

How to manufacture Power Knee

Manufacturing the Power Knee involves the intricate and meticulous application of technology, medical expertise, and rigorous quality checks.

Fees for manufacturing license for Power Knee

As the Power Knee falls under Risk Class B, a manufacturing license of MD5 is required. The fees for MD5 constitutes Rs. 5,000 for license and an additional Rs. 500 per product.

Why is a Manufacturing License Necessary for Power Knee?

A manufacturing license is imperative as it ensures the production of quality and safe medical devices, builds credibility in the industry, ensures regulatory compliance within the healthcare sector and safeguards consumers and patients from substandard products.

Steps to Obtain a CDSCO Manufacturing License for Power Knee

Acquiring a CDSCO manufacturing license for Power Knee involves the provision of pre-requisites such as:

Device Master File
Quality Management Certificate
Device Details
Site details, etc.

After submitting the necessary documentation, further steps entail the application review, inspection, and finally the approval for the license.

Frequently Asked Questions (FAQs)

Q1. What is risk class of Power Knee as per Medical Device Rules, 2017?

The Power Knee falls under Risk Class B.

Q2. What license is needed to manufacture Power Knee?

As Power Knee is classified under Risk Class B, the MD5 license is required.

Q3. What is fees for MD5 license for Power Knee?

The MD5 license for Power Knee costs a fee of Rs. 5,000 for license and an additional fee of Rs. 500 per product.

Q4. Who will issue a manufacturing license for Power Knee?

State FDA will issue a manufacturing license for Power Knee.

Q5. Is repackaging of Power Knee considered manufacturing?

Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing and by further definitions, medical devices are also drugs. Thus, repackaging of Power Knee is considered manufacturing necessitating an MD5 license.

Conclusion

Acquiring a manufacturing license may appear cumbersome, but the significance of this process cannot be overstated. In the end, it all comes down to ensuring quality, safety, and ultimately, safeguarding public health. If you need assistance or consultation regarding the licensing process, Pharmadocx Consultants is here to assist you. Reach out to us via our website "https://www.pharmadocx.com", or call us at "+91-7404557227", or drop us an email at "[email protected]".

For further information about the MD5 license, kindly read this article.