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CDSCO Manufacturing License for Powered lower extremity exoskeleton

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is the apex regulatory body in India. Its primary function revolves around the quality control, approval, and regulation of drugs and medical devices. In the vibrant and advanced industry of medical devices, the necessity and significance of manufacturing licenses cannot be overstated.

In this article, we highlight the process of obtaining the CDSCO manufacturing license for the Powered lower extremity exoskeleton, a groundbreaking device with massive potential in the field of medical rehabilitation. You can find more information and initiate the process on the CDSCO's portal.

What is a Powered Lower Extremity Exoskeleton?

A powered lower extremity exoskeleton, by definition, is an external, powered, motorized orthosis that is typically fitted over a person's paralyzed or weakened limbs. The main intention of this device is to assist with rehabilitation by empowering individuals with restricted mobility to walk again.

High on demand across hospitals and rehabilitation clinics, these exoskeletons can be used for an array of procedures such as post-stroke recovery, spinal cord injury rehabilitation, and enhanced mobility for people with certain neuromuscular diseases.

The Role of CDSCO in Medical Device Regulation

Central Drugs Standard Control Organization (CDSCO) created its own regulatory framework to address the unique needs of the medical device sector. CDSCO's mission has been to effectively and efficiently regulate the worldwide quality standards in the Indian pharmaceutical industry and to protect public health by assuring safety, efficacy, and quality of drugs and medical devices.

How to Manufacture a Powered Lower Extremity Exoskeleton

The exact manufacturing process for a Powered Lower Extremity Exoskeleton varies between brands and models. However, fundamental to all processes are precision, adherence to safety protocols, and strict compliance with the stringent regulations set by the regulatory bodies like the CDSCO.

Fees for manufacturing license for Powered Lower Extremity Exoskeleton

Being a Class B medical device, a Powered Lower Extremity Exoskeleton requires a MD5 license to manufacture. The fees for MD5 license involve a basic license fee of Rs. 5,000 and an additional Rs. 500 per product.

Why is a Manufacturing License Necessary for a Powered Lower Extremity Exoskeleton?

A state FDA license is mandatory to manufacture Class B medical devices including the Powered Lower Extremity Exoskeleton. The license upholds the confidence in a medical device, safeguarding the patients from substandard products. Ensuring quality and safety in medical device production, the significance of regulatory compliance goes far beyond just legal requisites.

Steps to Obtain a CDSCO Manufacturing License for a Powered Lower Extremity Exoskeleton

Prerequisite documents include the Device Master File, Quality Management Certificate, Device Details, and Site details. The step-by-step application process involves:

  1. Documentation collection and review
  2. Application submission to the relevant authority
  3. Responding efficiently to any queries regarding the application
  4. Gathering the approval of your application

There are common challenges manufacturers face during this process, and tips for how to overcome them. Link here to understand the detailed procedure for obtaining the MD5 license.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Powered Lower Extremity Exoskeleton as per Medical Device Rules, 2017?
Powered Lower Extremity Exoskeleton is a Class B risk device as per Medical Device Rules, 2017.

Q2. What license is needed to manufacture Powered Lower Extremity Exoskeleton?
For manufacturing a Powered Lower Extremity Exoskeleton, a MD5 license is required.

Q3. What is the fee for MD5 license for Powered Lower Extremity Exoskeleton?
The fee for an MD5 license is Rs. 5,000 for the license and an additional Rs. 500 per product.

Q4. Who will issue the manufacturing license for Powered Lower Extremity Exoskeleton?
The state FDA will issue the manufacturing license for Powered Lower Extremity Exoskeleton.

Q5. Is repackaging of Powered Lower Extremity Exoskeleton considered manufacturing?
Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs, and by further definitions, medical devices, is considered manufacturing. Therefore, repackaging of Powered Lower Extremity Exoskeleton also requires an MD5 license.

Conclusion

Considering the intricacies and stringent regulatory requirements, seeking professional consultation could significantly simplify the process. Pharmadocx Consultants, a renowned name in the industry, offers expert consultation and assistance in obtaining the CDSCO manufacturing licenses.

Feel free to reach out at Pharmadocx Consultants, call us at +91-7404557227, or email: [email protected].

Remember, accurate compliance can be the key to unlocking your product's potential in the thriving medical devices market.

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