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CDSCO Manufacturing License for Tongs antichoke device

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Introduction

Welcome to a detailed guide on understanding the regulatory and licensing nuances of an important medical device in the healthcare industry - the Tongs antichoke device. Governed in India by the Central Drugs Standard Control Organization (CDSCO), medical devices like these are paramount to a robust medical system that guarantees quality, efficacy, and safety to all stakeholders,

CDSCO, the premier drug regulatory organization of India, has key functions like regulation of medical devices and diagnostics, as well as import control for drugs. One of their critical roles is issuing manufacturing licenses to medical device companies, allowing them to produce, sell and distribute these critical items legally and ethically. This license doesn't just serve as a legal necessity but rather as a validation of the quality and safety that the product brings to the table.

The Tongs antichoke device, categorized under ENT Devices, is heavily relied upon in emergency situations to prevent choking and maintain patient safety. To take a closer look at CDSCO's perspective on this vital tool or to dive deep into the realm of medical devices, visit the official portal of CDSCO at https://cdscomdonline.gov.in/NewMedDev/Homepage.

What is a Tongs Antichoke Device?

A Tongs antichoke device, by definition, is a specialized, medical tool designed to avert asphyxiation or choking in a patient by effectively removing foreign objects lodged in a patient's airway. It is typically used in emergency situations across various medical and healthcare institutions.

Commonly associated with ensuring the safety and health of the patient, the Tongs Antichoke Device plays a pivotal role in lifesaving procedures such as dislodging foreign bodies and maintaining an open airway, thereby preventing potential choking hazards.

The Role of CDSCO in Medical Device Regulation

Established under the Drugs and Cosmetics Act, the CDSCO stands as the apex regulatory body for drugs and medical devices in India. With their primary mission to safeguard the public health by ensuring safe, effective, and quality medical products, CDSCO has an extensive regulatory framework that includes manufacturing licenses for medical devices, their quality standards, and their permissible use.

How to Manufacture a Tongs Antichoke Device

Producing a Tongs Antichoke Device involves the implementation of prescribed standards and regulations, robust quality management systems, and a robust infrastructure. To establish a manufacturing facility, one must first obtain the necessary approvals and licenses from CDSCO.

Fees for Manufacturing License for Tongs Antichoke Device

For manufacturing a Tongs Antichoke Device, which falls under the risk Class C, the required license is MD9. The fee structure for this license comprises Rs. 50,000 for the license and Rs. 1,000 per product.

Why is the Manufacturing License Necessary for Tongs Antichoke Device?

A manufacturing license is not just a legal formality for production but acts as a stringent quality measure. It ensures the produced medical devices are up to the standard, safe, and effective. Complying with regulatory norms not only upholds the manufacturer's credibility but protects the consumers and patients from potentially harmful and substandard products.

Steps to Obtain a CDSCO Manufacturing License for Tongs Antichoke Device

  1. Compile the necessary documentation, including Device Master File, Quality Management Certificate, Device Details, Site details, and so forth.
  2. Submit the compiled documents and filled-in application to the appropriate department.
  3. Wait for the documents and application to be reviewed and approved.
  4. Address any potential challenges that arise promptly and accurately.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of a Tongs Antichoke Device as per Medical Device Rules, 2017?

The Tongs Antichoke Device falls under risk Class C.

Q2. What license is needed to manufacture a Tongs Antichoke Device?

To manufacture a Tongs Antichoke Device, an MD9 license is required.

Q3. What is the fee for an MD9 license for Tongs Antichoke Device?

The fee for an MD9 license to manufacture a Tongs Antichoke Device is Rs. 50,000 for the license and Rs. 1,000 per product.

Q4. Who will issue the manufacturing license for Tongs Antichoke Device?

Since the Tongs Antichoke Device falls under risk Class C, CDSCO HQ in New Delhi will issue the manufacturing license.

Q5. Is repackaging of Tongs Antichoke Device considered manufacturing?

Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing and, by further definition, medical devices are also drugs. Medical Device Rules have been made under the provisions of Drug Act only and hence repackaging of Tongs Antichoke Device is also considered manufacturing requiring an MD9 license.

Conclusion

Navigating through regulatory approvals and licenses may seem like a daunting task. However, the experts at Pharmadocx Consultants are here to assist you in understanding the elaborative process better. For further consultation or assistance regarding the licensing process, do not hesitate to reach out to us at Pharmadocx Consultants, call us at +91-7404557227 or write to us at [email protected].

Also, to understand in detail about MD9 License, follow this link - https://pharmadocx.com/cdsco-md9-manufacturing-license-consultant-for-medical-devices-in-india/

Creating a safer and healthier world with quality medical devices is our motto, let's join hands and accomplish it.

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