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CDSCO Manufacturing License for Manual jet ventilation device

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. Their primary responsibility is to ensure the safety, effectiveness, and quality of drugs, cosmetics, and medical devices distributed in India. Manufacturing licenses play a crucial role in maintaining these standards within the medical device industry, ensuring manufacturers adhere to best practices and guarantee high-quality products for consumers.

In this article, we will be exploring the manufacturing specifications for a Manual Jet Ventilation Device (MJVD), a critical medical instrument used in the field of anesthesia. The CDSCO portal here provides additional information for medical device manufacturers.

What is a Manual Jet Ventilation Device?

A Manual Jet Ventilation Device (MJVD) is a noninvasive, manually operated device designed for emergency patient ventilation. When used with a separate compressed oxygen (O2) source, MJVDs provide crucial ventilation to patients with complete or partial airway obstruction. Often used in the field of anesthesia, this device is a lifesaver in numerous critical situations.

The Role of CDSCO in Medical Device Regulation

The CDSCO plays a pivotal role in the regulation of medical devices in India. With its mission to guarantee the safety, efficacy, and quality of medical devices, CDSCO has implemented a comprehensive regulatory framework. This framework includes licensing, monitoring, and quality assurance to ensure all medical devices meet the highest standards.

How to Manufacture a Manual Jet Ventilation Device

Regulations require manufacturers wishing to produce a Manual Jet Ventilation Device to obtain an MD9 license given its classification as a Class C medical device. Manufacturing processes must comply with all relevant CDSCO regulations and guidelines to ensure the safety and efficacy of the device's intended use.

Fees for Manufacturing License for a Manual Jet Ventilation Device

There is a set fee for obtaining an MD9 license to manufacture a Manual Jet Ventilation Device. The license fee is Rs. 50,000, and there's also a product fee of Rs. 1,000.

Why is a Manufacturing License Necessary for a Manual Jet Ventilation Device?

Obtaining a manufacturing license is a mandatory step to ensure quality and safety in the production of the Manual Jet Ventilation Device. Compliance with regulatory requirements not only protects consumers but also underlines the medical device industry's commitment to providing high-quality, safe products.

Steps to Obtain a CDSCO Manufacturing License for a Manual Jet Ventilation Device

The process of obtaining a manufacturing license for a Manual Jet Ventilation Device involves various prerequisites, including documentation like Device Master File, Quality Management Certificate, Device Details, Site details, etc. This documentation must be submitted, after which the application will go through the approval process. Overcoming challenges in this process is made easier with familiarity with CDSCO's guidelines and requirements.

Frequently Asked Questions (FAQs)

  • Q1: What is a risk class of Manual Jet Ventilation Device as per Medical Device Rules, 2017?

    The Manual Jet Ventilation Device is classified as a Class C risk as per the Medical Device Rules, 2017.

  • Q2: What license is needed to manufacture a Manual Jet Ventilation Device?

    An MD9 license is required to manufacture a Manual Jet Ventilation Device.

  • Q3: What is the fee for an MD9 license for a Manual Jet Ventilation Device?

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

  • Q4: Who will issue the manufacturing license for a Manual Jet Ventilation Device?

    The manufacturing license for a Manual Jet Ventilation Device will be issued by the CDSCO HQ in New Delhi.

  • Q5: Is repackaging of a Manual Jet Ventilation Device considered manufacturing?

    Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing, and hence repackaging of the Manual Jet Ventilation Device is also considered manufacturing and requires an MD9 license.

Conclusion

For any further inquiries or consultation regarding the licensing process for a Manual Jet Ventilation Device, please reach out to Pharmadocx Consultants. Our experts are available to assist you with your licensing needs. You can call us at +91-7404557227 or email us at [email protected].

Should you need more information on the MD9 license, you can read our detailed article here.

Pharmadocx is committed to supporting you through the complex licensing process and ensuring regulatory compliance. We are dedicated to providing our expertise, to help you deliver high-quality, safe and effective medical devices to patients.

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