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CDSCO Manufacturing License for Needle electrode.

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is the apex regulatory body in India responsible for regulating medical devices, among other responsibilities like regulating drugs and cosmetics. CDSCO serves a pivotal role, ensuring that the medical devices manufactured or imported into India meet the required safety and quality standards. Having a manufacturing license is crucial in the medical device industry, ensuring quality control and patient safety.

One such device that plays a critical role in medical procedures is the Needle Electrode, a device advocating its importance in the healthcare industry. For more information on CDSCO's role and procedures, visit their official portal.

What is a Needle Electrode?

A Needle Electrode is a medical device that is inserted subcutaneously, that is, under the skin, to stimulate or record electrical signals within the body. This electrode is used in numerous medical procedures involving nerve conduction and neuromuscular testing.

The Role of CDSCO in Medical Device Regulation

The CDSCO is entrusted with the responsibility of regulating the manufacturing, import, and clinical trials related to medical devices in India. The purpose of this regulatory body is to protect public health by ensuring that the medical systems that reach the market align with international safety and quality standards.

How to Manufacture a Needle Electrode

Manufacturing a Needle Electrode, a Class C medical device, requires a set of manufacturing processes which must adhere to the guidelines and standards laid by the CDSCO.

Fees for Manufacturing License for Needle Electrode

To manufacture a Class C medical device such as a Needle Electrode, an MD9 License is required. The fee for this license is Rs. 50,000 and Rs. 1,000 per product. For more details about MD9 license, read this article.

Why is a Manufacturing License Necessary for a Needle Electrode?

Manufacturing licenses are mandatory for every medical device to ensure their quality and safety. Regulatory compliance in the healthcare sector is of utmost importance to protect consumers and patients from substandard products.

Steps to Obtain a CDSCO Manufacturing License for Needle Electrode

Here are the basic steps to obtain the license:

  1. Submission of required documents like Device Master File, Quality Management Certificate, Device Details, Site details, etc.
  2. Review of the application by CDSCO.
  3. Inspection of manufacturing site if required.
  4. Issuance of license after approval.

Frequently Asked Questions (FAQs)

Q1. What is risk class of Needle Electrode as per Medical Device Rules, 2017?
Needle Electrode falls under Class C as per Medical Device Rules, 2017.

Q2. What license is needed to manufacture Needle Electrode? License MD9 is needed to manufacture Needle Electrode.

Q3. What is fees for MD9 license for Needle Electrode? The fee for MD9 license is Rs. 50,000 and Rs. 1,000 per product.

Q4. Who will issue manufacturing license for Needle Electrode? CDSCO Headquarters in New Delhi will issue the license for Class C devices like Needle Electrode.

Q5. Is repackaging of Needle Electrode considered manufacturing? Yes, as per the Drugs and Cosmetics Act, repackaging is considered manufacturing. Hence, repackaging of Needle Electrode also requires an MD9 license.

Conclusion

Obtaining a manufacturing license for a medical device is a complex process and requires detailed knowledge and understanding of the regulatory landscape. If you need any assistance or consultation regarding the licensing process, reach out to Pharmadocx Consultants. For quick assistance, call on "+91-7404557227" or email at "[email protected]".

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