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CDSCO Manufacturing License for Spinal needle bioimpedance navigation unit

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is India's primary regulatory body for pharmaceuticals and medical devices. Its role is crucial in safeguarding public health and safety by ensuring the quality, safety, and efficacy of the drugs and medical devices available in the market. CDSCO is responsible for granting licenses for the manufacture of medical devices, clinical trials, import and export of drugs, and overseeing the quality control of drugs and medical devices.

In the medical device industry, manufacturing licenses play a vital role in ensuring the quality and safety of products. These licenses are granted after a thorough evaluation of the company's quality management system and device information. This is where the significance of the Spinal Needle Bioimpedance Navigation Unit comes in. This is a highly specialized medical device used in the arena of anesthesia. An essential link for potential manufacturers and stakeholders, the CDSCO's online portal cdscomdonline.gov.in serves as a vital resource.

What is a Spinal Needle Bioimpedance Navigation Unit?

A Spinal Needle Bioimpedance Navigation Unit is a medical device designed to transmit and receive electrical signals to/from a specialized spinal needle. The device analyzes the bioimpedance data in real time, allowing it to predict the location of the needle tip, typically used under the category of anesthesia. This device plays a significant role in procedures requiring precision and accuracy, ensuring optimal patient safety and efficiency.

The Role of CDSCO in Medical Device Regulation

The CDSCO plays an instrumental role in the regulation of medical devices in India. Its mission is to ensure the quality and safety of pharmaceuticals and medical devices in the Indian market. CDSCO's regulatory framework for medical devices is diligent and robust, involving rigors of quality checks, audits and approvals. The organization diligently oversees the manufacturing processes, licensing, and quality control parameters of medical devices.

How to Manufacture a Spinal Needle Bioimpedance Navigation Unit

The manufacturing of a Spinal Needle Bioimpedance Navigation Unit, due to its high-risk classification under Class D by CDSCO involves detailed processes. High standard clean rooms, state-of-the-art machinery, and experts with specialized skills in product development and manufacturing, are some of the prerequisites.

Fees for manufacturing license for Spinal Needle Bioimpedance Navigation Unit

Medical devices classified under class D requires an MD9 license for manufacturing. The fees for this is Rs. 50,000 for the license and Rs. 1,000 per product.

Why is a Manufacturing License Necessary for Spinal Needle Bioimpedance Navigation Unit?

Obtaining a manufacturing license is mandatory and of great importance in the healthcare sector. It ensures that high-quality standards and safety measures are adhered to in the production process. Regulatory compliance is necessary for the healthcare sector to protect consumers and patients from substandard products. For high-risk devices like the Spinal Needle Bioimpedance Navigation Unit, adherence to regulatory compliance is of utmost importance.

Steps to Obtain a CDSCO Manufacturing License for Spinal Needle Bioimpedance Navigation Unit

The steps to obtain a manufacturing license for the Spinal Needle Bioimpedance Navigation Unit involves the submission of essential documents like the Device Master File, Quality Management Certificate, Device Details and Site Details, among others. Once the application is submitted, it goes through a series of evaluations before approval is granted. To address any difficulties faced, one might take assistance from qualified consultants to guide through the process.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Spinal Needle Bioimpedance Navigation Unit as per Medical Device Rules, 2017?

The Spinal Needle Bioimpedance Navigation Unit falls under the high-risk Class D.

Q2. What license is needed to manufacture a Spinal Needle Bioimpedance Navigation Unit?

An MD9 license is required to manufacture the Spinal Needle Bioimpedance Navigation Unit.

Q3. What is the fee for MD9 license for a Spinal Needle Bioimpedance Navigation Unit?

The fee for an MD9 license for manufacturing a Spinal Needle Bioimpedance Navigation Unit is Rs. 50,000 and Rs. 1000 is charged per product.

Q4. Who will issue the manufacturing license for a Spinal Needle Bioimpedance Navigation Unit?

The CDSCO HQ in New Delhi will issue the manufacturing license for Class D devices like the Spinal Needle Bioimpedance Navigation Unit.

Q5. Is repackaging of a Spinal Needle Bioimpedance Navigation Unit considered manufacturing?

Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing and medical devices are also considered drugs under the act. Therefore, repackaging of the Spinal Needle Bioimpedance Navigation Unit also requires a license (MD9).

Conclusion

Obtaining a manufacturing license can be a complex process requiring attention to detail and in-depth understanding of the process. For more information or assistance in obtaining a license, feel free to reach out to Pharmadocx Consultants at +91-7404557227 or email your query to [email protected]. For a detailed understanding of the MD9 licensing process for high-risk medical devices like Spinal Needle Bioimpedance Navigation Unit, follow the link.

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