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CDSCO Manufacturing License for Electronic goniometer/kinesiol ogy sensor

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Introduction

The Central Drugs Standard Control Organization (CDSCO) plays a vital role in the Indian healthcare sector, particularly in the area of medical devices. Tasked with safeguarding and enhancing public health by ensuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices, CDSCO sets stringent standards for manufacturers to adhere to.

Within the fast-growing medical device industry, manufacturing licenses are crucial. They serve as an assurance that a particular product or device has been evaluated rigorously, attesting to its safety and efficacy. One such pertinent device is the Electronic Goniometer/Kinesiology sensor.

In the sphere of rehabilitation and physical therapy, this device is of immense importance. It evaluates a patient's range of motion, movement of individual joints or limbs, and spine. Thus, it is typically employed in a clinical setting, either before or after a medical or surgical intervention, or to gauge physical fitness.

For more detailed information, feel free to visit the CDSCO's portal.

What is an Electronic Goniometer/Kinesiology Sensor?

An Electronic Goniometer/Kinesiology Sensor is a technologically advanced tool used to measure the range of motion or movement in individual joints, limbs or the spine. This device works by quantifying a patient's biomechanical parameters, translating the data for clinicians to analyze and base their treatment plans on.

Given its essential role in gauging physical fitness and rehabilitation potential, this device is commonly used in health assessments, surgical interventions, and post-surgical recoveries.

The Role of CDSCO in Medical Device Regulation

Instituted with the mission of safeguarding public health in India, CDSCO plays a significant role in regulating medical devices. The organization's regulatory framework for medical devices is comprehensive, taking into account the risk factors and potential impacts associated with their use.

How to manufacture an Electronic Goniometer/Kinesiology Sensor

The manufacturing process for an Electronic Goniometer/Kinesiology sensor, like any medical device, entails strict adherence to CDSCO guidelines and specifications. The product must comply with regulatory requirements in every stage, from design to final product testing.

Fees for manufacturing license for Electronic Goniometer/Kinesiology Sensor

For Class B devices like an Electronic Goniometer/Kinesiology sensor, a MD5 license is required which costs Rs. 5,000 for the license and an additional Rs. 500 per product.

Why is a Manufacturing License Necessary for Electronic Goniometer/Kinesiology Sensor?

A manufacturing license is essential for producing the Electronic Goniometer/Kinesiology sensor or any medical device. As the CDSCO mandates it, non-compliance could lead to severe legal penalties. This necessity stems from the importance of ensuring that medical devices meet the highest standards of quality and safety. Furthermore, regulatory compliance reinforces trust in the healthcare sector and protects patients and consumers against substandard products.

Steps to Obtain a CDSCO Manufacturing License for Electronic Goniometer/Kinesiology Sensor

Acquiring a CDSCO manufacturing license requires the submission of various documents, including the Device Master File, Quality Management Certificate, Device Details, Site details, among others. Once the application is submitted, it goes through a comprehensive review process before approval. It's crucial to anticipate potential challenges and strategize ways to tackle them effectively.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Electronic Goniometer/Kinesiology Sensor as per Medical Device Rules, 2017? A. The Electronic Goniometer/Kinesiology Sensor is classified as a Class B device.

Q2. What license is needed to manufacture an Electronic Goniometer/Kinesiology Sensor? A. To manufacture an Electronic Goniometer/Kinesiology Sensor, an MD5 license is required.

Q3. What is the fee for an MD5 license for an Electronic Goniometer/Kinesiology Sensor? A. The fee for an MD5 license is Rs. 5,000 with an additional Rs. 500 per product.

Q4. Who will issue the manufacturing license for Electronic Goniometer/Kinesiology Sensor? A. For a Class B device like the Electronic Goniometer/Kinesiology Sensor, the State FDA will issue the license.

Q5. Is repackaging of an Electronic Goniometer/Kinesiology Sensor considered manufacturing? A. Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of medical devices, which are regarded as drugs, is considered manufacturing. Therefore, repackaging of an Electronic Goniometer/Kinesiology Sensor also necessitates an MD5 license.

Conclusion

Whether you're seeking further information about the manufacturing and licensing process or need professional assistance, reach out to Pharmadocx Consultants for a comprehensive consultation. You can either visit our website, call us at +91-7404557227, or drop an email to [email protected] for a prompt response.

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