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CDSCO Manufacturing License for Powered nasal irrigator

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is India's primary national regulatory body for pharmaceuticals and medical devices. The organization, under the Directorate General of Health Services, is responsible for ensuring safety, efficacy, and quality assurance in these health-related industries. It upholds rigorous standards for the manufacture, import, conduct of clinical trials, registration, and regulation of the market distribution of medical devices.

One of its most critical responsibilities is the issuance of manufacturing licenses. These licenses are not mere formalities; they play an integral part in the medical device industry, considering they validate the quality and safety of products manufactured. Only license-holders are permitted to produce medical devices, which ensures patient safety and upholds health care standards.

Today, we will explore the "Powered Nasal Irrigator", a device that plays a significant role in the world of ENT (Ear, Nose, and Throat) devices. Recognizing the importance of this device and the need for a manufacturing license under CDSCO's regulatory framework adds a new layer to our understanding of our medical system. You can learn more about CDSCO and their regulatory policies on their official portal, here.

What is a Powered Nasal Irrigator?

A powered nasal irrigator is an AC-powered device, primarily designed and used to cleanse the nasal cavity. The device works by circulating a pressure-controlled pulsating stream of water, effectively removing any accumulated debris or mucus.

Commonly used in ENT procedures, the powered nasal irrigator can be a part of a spectrum of treatments, from simple sinus irrigations for the general public to more complex medical procedures such as sinus or post-surgical care.

The Role of CDSCO in Medical Device Regulation

The CDSCO acts as the watchdog of the Indian pharmaceutical and medical device industry. They provide a robust regulatory framework to ensure the safe and efficient production and distribution of medical devices. This structure encompasses procedures for licensing, quality assessments, clinical trials and market control, all with the intention to protect consumers and maintain a high standard of health care products.

How to Manufacture a Powered Nasal Irrigator

The manufacturing process of any medical device, including a powered nasal irrigator, must align with CDSCO's regulatory requirements. This process involves obtaining the necessary manufacturing license, MD5 in the case of the Class B risk category powered nasal irrigator, and adhering to the specifics outlined in the license requisites.

Fees for Manufacturing License for a Powered Nasal Irrigator

Since a powered nasal irrigator falls under risk Class B, the necessary licensing fee falls within the MD5 classification. That leads to a base fee of Rs. 5,000 for the license and an additional Rs. 500 per device.

Why is a Manufacturing License Necessary for a Powered Nasal Irrigator?

Having a manufacturing license for producing powered nasal irrigators, or any other medical device for that matter, is non-negotiable. It is an essential element to guarantee compliance with established safety and quality standards. Having the license holds manufacturers accountable for their products' quality and safety and protects patients and consumers from receiving substandard devices.

Steps to Obtain a CDSCO Manufacturing License for a Powered Nasal Irrigator

Acquiring a CDSCO manufacturing license for a powered nasal irrigator is straightforward when you understand the process:

  1. Prepare all prerequisite documentation, including the Device Master File, Quality Management Certificate, Device Details, Site details, and others as required.
  2. Submit your application with all necessaries.
  3. Wait for the review and assessment phase.
  4. Upon approval, your license will be granted.

You can get support during this process from experienced consultants here.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of a Powered Nasal Irrigator as per Medical Device Rules, 2017?

The Powered Nasal Irrigator is categorized under risk Class B.

Q2. What license is needed to manufacture a Powered Nasal Irrigator?

To manufacture a Powered Nasal Irrigator, an MD5 license is needed.

Q3. What is the fee for an MD5 license for a Powered Nasal Irrigator?

The fee for an MD5 license for a Powered Nasal Irrigator is Rs. 5,000 plus Rs. 500 per product.

Q4. Who will issue the manufacturing license for a Powered Nasal Irrigator?

The state FDA will issue the manufacturing license for a Powered Nasal Irrigator.

Q5. Is repackaging of a Powered Nasal Irrigator considered manufacturing?

Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. Medical devices, including the Powered Nasal Irrigator, are also classified as drugs, requiring an MD5 license for repackaging.

Conclusion

The process of obtaining a CDSCO manufacturing license for a powered nasal irrigator or any other medical device requires navigating through a detailed regulatory framework. This task doesn't have to be daunting if you seek the right professional guidance. That's why our team at Pharmadocx Consultants is here to help. Reach out to us for a consultation or assistance regarding your licensing process at +91-7404557227 or email us at [email protected]. Let our expertise simplify your path to regulatory compliance and success in the medical device industry.

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