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CDSCO Manufacturing License for Electronically operated Tourniquet Single & Double Cuff Consol

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Introduction

The medical device industry is a dynamic and constantly evolving field that relies heavily on strict regulations and safeguards to ensure the quality and safety of products. One of the key players in governing and regulating this sector in India is the Central Drugs Standard Control Organization (CDSCO). This body of the Indian government is responsible for ensuring the safety, effectiveness, and quality of medicines, cosmetics, diagnostics, and medical devices. Its stringent rules and standards are designed to protect consumers and facilitate the development of the health sector.

An essential aspect that manufacturers need to fulfill in this industry is the requirement of obtaining licenses. One such notable license is the one issued by CDSCO for the manufacturing of medical devices. The license is a testament to the manufacturer's adherence to safety and quality standards, ensuring that they produce reliable medical devices for consumer use.

In this article, we will explore the CDSCO manufacturing license for the Electronically operated Tourniquet Single & Double Cuff Console. This widely used medical device has played an integral part in surgeries and medical procedures. The CDSCO's portal, available here, offers more details and information regarding various regulations, licenses, and requirements.

What is an Electronically operated Tourniquet Single & Double Cuff Console?

An electronically operated tourniquet is a medical device used during surgical procedures to control blood flow in a patient's limb. This device consists of a console and one or two (single or double) inflatable cuffs that can be tightened around a limb. The objective is to temporarily restrict the blood flow to a particular area, allowing the surgeon to perform the operation with minimal blood loss.

The Electronically operated Tourniquet Single & Double Cuff Console became increasingly popular due to its precision, safety features, and ease of use. It finds its application in general surgical procedures along with orthopedic surgeries.

The Role of CDSCO in Medical Device Regulation

CDSCO plays a pivotal role in the regulation of medical devices in India. Its robust framework that aligns with international standards reiterates the commitment of the organization to patient safety and industry growth.

Every medical device, like the Electronically operated Tourniquet Single & Double Cuff Console, must be produced and distributed in compliance with CDSCO's regulations. These standards ensure the device's safety and effectiveness, safeguarding the wellbeing of patients.

How to Manufacture Electronically operated Tourniquet Single & Double Cuff Console

Fees for Manufacturing License for Electronically operated Tourniquet Single & Double Cuff Console

As the Electronically operated Tourniquet Single & Double Cuff Console belongs to Class B risk category, the required license for its manufacturing is MD5. The license's fee is Rs. 5,000, coupled with Rs. 500 per product. For more details on the manufacturing license, you can visit this link

Why is a Manufacturing License Necessary for Electronically operated Tourniquet Single & Double Cuff Console?

Without a doubt, a manufacturing license is a mandatory requirement for any producer in the medical device industry. The license ensures the quality and safety of the product, aligning it with the regulations set by CDSCO.

Furthermore, a license epitomizes the manufacturer's commitment to meet regulatory compliance, a critical factor in the healthcare sector. It also assures consumers and healthcare providers that the device has undergone stringent testing and meets all necessary safety standards.

Steps to Obtain a CDSCO Manufacturing License for Electronically operated Tourniquet Single & Double Cuff Console

Obtaining a manufacturing license comprises multiple stages, ranging from preparing requisite documents to submitting the application. The common documents required include Device Master File, Quality Management Certificate, Device Details, Site details, among others. The application process involves submitting the complete form, review of the application by CDSCO, hearing, and final approval.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Electronically operated Tourniquet Single & Double Cuff Console as per Medical Device Rules, 2017? Answer: The Electronically operated Tourniquet Single & Double Cuff Console falls under the Class B risk category as per Medical Device Rules, 2017.

Q2. What license in needed to manufacture Electronically operated Tourniquet Single & Double Cuff Console? Answer: The MD5 license is required to manufacture Electronically operated Tourniquet Single & Double Cuff Console.

Q3. What is the fees for MD5 license for Electronically operated Tourniquet Single & Double Cuff Console? Answer: The fees for the MD5 License are Rs. 5,000 for the license and an additional Rs. 500 per product.

Q4. Who will issue a manufacturing license for Electronically operated Tourniquet Single & Double Cuff Console? Answer: For Class B devices, like Electronically operated Tourniquet Single & Double Cuff Console, the manufacturing license is issued by the state FDA.

Q5. Is repackaging of Electronically operated Tourniquet Single & Double Cuff Console considered manufacturing? Answer: Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. By extension, medical devices are also considered drugs. Hence, the repackaging of the Electronically operated Tourniquet Single & Double Cuff Console is also considered manufacturing and requires an MD5 License.

Conclusion

Navigating the landscape of medical device licensing can be daunting. However, with the right guidance and assistance, acquiring a license for your Electronically operated Tourniquet Single & Double Cuff Console can be a streamlined and clear process.

We encourage you to reach out to the experts at Pharmadocx Consultants for a comprehensive and hassle-free licensing journey. To get in touch, click on Pharmadocx Consultants, call us directly on +91-7404557227, or email your queries to [email protected].

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