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CDSCO Manufacturing License for External upper esophageal sphincter compression device

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is India's main regulatory body for pharmaceuticals and medical devices. The CDSCO is entrusted with several responsibilities including the approval of new drugs, the conduct of clinical trials, and maintaining quality and standard of approved drugs. Furthermore, the CDSCO plays a pivotal role in granting licenses for manufacturing medical devices.

Manufacturing licenses are vital in the medical device industry. They ensure proper standards are maintained and that the released products are both safe and effective. This is particularly crucial for devices that directly impact human health.

One such device that calls for the utmost standard and safety is the External Upper Esophageal Sphincter Compression Device. Its significance in the medical field is quite evident, warranting a closer look into the device and the licencing requirements involved.

Detailed information about the CDSCO and its services can be found on its official portal here.

What is an External Upper Esophageal Sphincter Compression Device?

An External Upper Esophageal Sphincter Compression Device is a device designed for applying external pressure on the cricoid cartilage. The main intent is to alleviate the symptoms of laryngopharyngeal reflux disease, a condition where stomach fluids reflux into the throat causing irritation and damage to the larynx.

The device has become integral in Ear, Nose, and Throat (ENT) procedures, within doctor's offices, and for home use by patients experiencing laryngopharyngeal reflux.

The Role of CDSCO in Medical Device Regulation

CDSCO has long been pivotal in the regulation of medical devices in India. With a broad mission, CDSCO aims to safeguard and enhance public health by ensuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices.

Their regulatory framework for medical devices is rigorously comprehensive, taking into account various risk factors, device categorizations, and ensuring manufacturer adherence to globally recognized standards of production and quality assurance.

How to manufacture an External Upper Esophageal Sphincter Compression Device

The External Upper Esophageal Sphincter Compression Device, being a Class C device, requires an MD9 license for manufacturing.

Fees for manufacturing license for External Upper Esophageal Sphincter Compression Device

With respect to Class C devices, the fees involved are Rs. 50,000 for the license and Rs. 1,000 per product.

Why is a Manufacturing License Necessary for External Upper Esophageal Sphincter Compression Device?

Securing a manufacturing license, especially for Class C devices like the External Upper Esophageal Sphincter Compression Device, is a compulsory requirement. It assures that the device, integral to laryngopharyngeal reflux treatments, meets high quality and safety standards.

Regulatory compliance in the healthcare sector is necessary for ensuring that patients receive safe and effective treatment. Moreover, manufacturing licenses are essential in protecting consumers from substandard products that may not meet required safety and efficacy standards.

Steps to Obtain a CDSCO Manufacturing License for External Upper Esophageal Sphincter Compression Device

  1. Prepare requisite documents including the Device Master File, Quality Management Certificate, Device Details, and Site Details.
  2. Submit the application filled with appropriate details to CDSCO.
  3. Acquire approval from respective authorities.
  4. Overcome challenges through expert consultation and guidance.

Frequently Asked Questions (FAQs)

  1. Q: What is the risk class of an External Upper Esophageal Sphincter Compression Device as per Medical Device Rules, 2017?

    A: The risk class is C.

  2. Q: What license is needed to manufacture an External Upper Esophageal Sphincter Compression Device?

    A: An MD9 license is required for manufacturing the device.

  3. Q: What is the fees for MD9 license for External Upper Esophageal Sphincter Compression Device?

    A: The fees for an MD9 license for this device is Rs. 50,000 for the license and Rs. 1,000 per product.

  4. Q: Who will issue a manufacturing license for an External Upper Esophageal Sphincter Compression Device?

    A: For Class C devices like these, the license will be issued by the CDSCO HQ in New Delhi.

  5. Q: Is repackaging of the External Upper Esophageal Sphincter Compression Device considered manufacturing?

    A: Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing and by further definitions, medical devices are also drugs.

Get all your queries resolved about Class C devices and MD9 license by visiting here

Conclusion

Manufacturing licenses are of utmost importance and a comprehensive understanding of the process can often be overwhelming. Do not hesitate to reach out for consultation or assistance regarding the licensing process. Feel free to contact Pharmadocx Consultants through their official website or call them on "+91-7404557227" or simply send an email to [[email protected]".

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