Published on

CDSCO Manufacturing License for Foot sensorimotor therapy mechanical neurostimulator

Authors
  • avatar
    Name
    CDSCO Licenses Blog
    Twitter

Introduction

The Central Drugs Standard Control Organization (CDSCO) plays a pivotal role in India's healthcare sector. Their primary functions include approving new drugs, granting licenses for manufacturing pharmaceuticals and medical devices, conducting clinical trials, and standard inspections. They ensure the quality, safety and efficacy of drugs and medical devices in India.

Manufacturing licenses are spheres of primary concern as they are indicators of quality assurance. One such medical device that demands our attention is the Foot sensorimotor therapy mechanical neurostimulator. This device holds significant importance in the medical industry, especially in the field of neurology and rehabilitation.

You can access more information about CDSCO and its services on their portal here.

What is a Foot Sensorimotor Therapy Mechanical Neurostimulator?

A Foot sensorimotor therapy mechanical neurostimulator is a medical device used for providing non-invasive peripheral neurostimulation to the feet, thus improving somatosensory integration. This is particularly beneficial for patients suffering from neurological or neurodegenerative disorders like Parkinson's disease as it aids in reducing motor impairments and balance disturbances.

The Role of CDSCO in Medical Device Regulation

The CDSCO has been an integral part of the healthcare sector. Their mission includes ensuring that all pharmaceuticals and medical devices are up to the mark when it comes to safety, efficacy and quality. To guarantee this, they have a robust regulatory framework in place for medical devices.

How to Manufacture a Foot Sensorimotor Therapy Mechanical Neurostimulator

The manufacture of such devices involves a series of meticulous steps that ensures precision and safety.

Fees for Manufacturing License for Foot Sensorimotor Therapy Mechanical Neurostimulator

Since the Foot sensorimotor therapy mechanical neurostimulator falls under Risk Class C, it requires an MD9 license. The fees for this license are INR 50,000, with an additional INR 1,000 per product.

For more information about the MD9 license, you can refer to this link.

Why is a Manufacturing License Necessary for Foot sensorimotor therapy mechanical neurostimulator?

Obtaining a manufacturing license is not just a mandate but also carries a lot of significance in many aspects. It ensures the production of high-quality products that are compliant with regulatory norms. Also, it aids in protecting consumers and patients from substandard products.

Steps to Obtain a CDSCO Manufacturing License for a Foot sensorimotor therapy mechanical neurostimulator

The prerequisites for obtaining a manufacturing license include a Device Master File, Quality Management Certificate, Device Details, Site details, among others. The application process is a straightforward journey from submission to approval. Despite this seeming simplicity, it is not uncommon to encounter challenges which can be overcome with correct guidance.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Foot Sensorimotor Therapy Mechanical Neurostimulator as per Medical Device Rules, 2017?

  • The risk class of Foot Sensorimotor Therapy Mechanical Neurostimulator is Class C.

Q2. What license is needed to manufacture Foot Sensorimotor Therapy Mechanical Neurostimulator?

  • An MD9 license is required to manufacture Foot Sensorimotor Therapy Mechanical Neurostimulator.

Q3. What is the fees for MD9 license for Foot Sensorimotor Therapy Mechanical Neurostimulator?

  • The fees for MD9 license are INR 50,000, plus INR 1,000 per product.

Q4. Who will issue the manufacturing license for Foot Sensorimotor Therapy Mechanical Neurostimulator?

  • The CDSCO HQ in New Delhi will issue the license.

Q5. Is repackaging of Foot Sensorimotor Therapy Mechanical Neurostimulator 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. Hence, repackaging of Foot Sensorimotor Therapy Mechanical Neurostimulator is also considered manufacturing requiring a license on MD9.

Conclusion

The process of obtaining a manufacturing license for a medical device like a Foot sensorimotor therapy mechanical neurostimulator can be complex. If you need assistance with the licensing process, feel free to reach out to Pharmadocx Consultants. Call at +91-7404557227, write an email to [email protected], or visit https://www.pharmadocx.com/ for more details. Remember, right consultation makes the process easier.

cdsco import license in india banner
cdsco manufacturing license in india banner