CDSCO Manufacturing License for Depth electrode.

Introduction

The Central Drugs Standard Control Organization (CDSCO) plays a pivotal role in India's healthcare sector regulating the standard of imported and domestically produced drugs & medical devices. Key functions include laying down standards, granting licenses, clinical trial permissions, and monitoring adverse events.

Manufacturing licenses impart structure, safety, and quality control to the medical device industry, ensuring that healthcare products meet albeit exceed, the efficacy and safety standards required for the patient's well-being.

In this blog, we will explore the medical device known as the 'Depth Electrode,' its significance in neurological medical procedures, and the CDSCO licensing process for manufacturing this device in India.

For further details, you can visit CDSCO's official website - CDSCO Online

• What is a Depth Electrode?
• The Role of CDSCO in Medical Device Regulation
• How to Manufacture a Depth Electrode
• Fees for a Manufacturing License for Depth Electrode
• Why is a Manufacturing License Necessary for a Depth Electrode?
• Steps to Obtain a CDSCO Manufacturing License for Depth Electrode
• Frequently Asked Questions (FAQs)
• Conclusion

What is a Depth Electrode?

A Depth Electrode, used for temporary simulation or recording electrical signals at subsurface levels of the brain, is crucial for neurological procedures, particularly in epilepsy surgery. Its primary purpose is to record intracranial electroencephalography (EEG) from specific areas of the brain.

These electrodes aid in mapping brain activity, assisting surgeons in understanding the regions of the brain to be treated or removed.

The Role of CDSCO in Medical Device Regulation

Established under the Drugs and Cosmetics Act, the CDSCO plays a pivotal role in safeguarding and enhancing public health in India. A significant part of its mandate includes regulating the manufacturing and distribution of medical devices across the country.

CDSCO has set up a rigorous regulatory framework for medical devices relying on the device's potential risk to the patient. This risk-based approach ensures rigorous oversight and control over medical devices, including Depth Electrodes.

How to Manufacture a Depth Electrode

The manufacturing of Depth Electrodes falls under risk class C, which requires the MD9 manufacturing license governed by the CDSCO.

Fees for a Manufacturing License for Depth Electrode

The Depth Electrodes, falling under risk class C, requires an MD9 license. The fees for acquiring an MD9 license are Rs. 50,000, along with Rs. 1,000 per product.

Why is a Manufacturing License Necessary for a Depth Electrode?

Acquiring a manufacturing license is essential to ensure the quality, safety, and efficacy of the medical devices produced. Complying with regulatory guidelines not only protects consumers and patients from sub-standard products but also safeguards the reputation of manufacturers by ensuring they meet required manufacturing standards.

Steps to Obtain a CDSCO Manufacturing License for Depth Electrode

1. Prepare necessary documentation, including a Device Master File, Quality Management Certificate, Device Details, and Site details.
2. Submit the application along with the requisite documents to the CDSCO.
3. The CDSCO reviews the documents and approves the application.
4. Confront any challenges during the application process head-on, supported by experienced consultants or agency.

Frequently Asked Questions (FAQs)

• Q1. What is the risk class of Depth Electrode as per Medical Device Rules, 2017?

  The risk class of Depth Electrode is Class C.

• Q2. What license is needed to manufacture Depth Electrode?

  To manufacture a Depth Electrode, an MD9 license is required.

• Q3. What is the fee for an MD9 license for Depth Electrode?

  The fee for an MD9 license for Depth Electrode is Rs. 50,000, along with Rs. 1,000 per product.

• Q4. Who will issue a manufacturing license for Depth Electrode?

  For Depth Electrodes (Class C devices), the CDSCO HQ in New Delhi will issue the license.

• Q5. Is repackaging of Depth Electrode considered manufacturing?

  Yes, as per the 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 Depth Electrode is considered manufacturing requiring an MD9 license.

For further guidance on the MD9 license, visit this link - MD9 License Details

Conclusion

The licensing process may appear complex; however, expert help is at hand. Reach out to Pharmadocx Consultants for assistance regarding the licensing process or call on +91-7404557227, or email to [email protected].