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CDSCO Manufacturing License for Ear, nose, and throat microsurgical carbon dioxide laser

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is India's central regulatory body for pharmaceuticals and medical devices. The organization's primary duty lies in ensuring the safety, efficacy and quality of drugs, cosmetics, and medical devices being manufactured or imported into India. It is instrumental in setting standards, regulating market authorization, post-market surveillance and enforcing industry standards for promoting public health and wellbeing.

In the medical device industry, manufacturing licenses play a significant role. It serves as a formal permission granted to manufacturers enabling them to adhere to specific standards and conditions when manufacturing medical devices, ensuring product safety and efficacy.

Now, let's delve into the world of Ear, nose, and throat microsurgical carbon dioxide lasers, a profound medical device used in microsurgical procedures.

For more information about CDSCO and their licensing process for medical devices, please click here.

What Is an Ear, Nose, and Throat Microsurgical Carbon Dioxide Laser?

An ear, nose, and throat microsurgical carbon dioxide laser is a high-tech medical device specifically designed for the surgical excision of tissue from the ear, nose, and throat area. The device is extensively used in microsurgical procedures, primarily designed to excise lesions and tumors of the vocal cords and adjacent areas. It offers precision and control, reducing the risk of damage to surrounding tissues during the surgery.

Common uses of the device include vocal cord surgery, polyp removal, and other microsurgeries involving the ear, nose, and throat area.

The Role of CDSCO in Medical Device Regulation

The CDSCO plays a significant role in establishing a robust regulatory framework for medical devices in India. The main mission of the organization is to promote public health by ensuring safety, efficacy, and quality of the medical devices and pharmaceuticals available.

CDSCO's regulatory framework for medical devices aims at streamlining and enhancing medical device regulation, ensuring compliance with specific standards and protocols, which is a fundamental aspect of encouraging healthcare advancements in India.

How to Manufacture an ENT Microsurgical Carbon Dioxide Laser

Manufacturing an ENT microsurgical CO2 laser involves a series of critical steps to ensure it functions accurately, safely, and within the bounds of medical and ethical standards. The process includes everything from design, quality control, testing, and validation, all the way through to packaging and labelling.

Fees for Manufacturing License for ENT Microsurgical Carbon Dioxide Laser

For manufacturing an ENT microsurgical laser, categorized under risk class C, an MD9 license is required. The fee for obtaining an MD9 license is Rs. 50,000, and an additional fee of Rs. 1,000 per product applies.

Why is a Manufacturing License Necessary for the ENT Microsurgical Carbon Dioxide Laser?

Manufacturing licenses are mandatory for the production of medical devices in India, as per the regulations laid down by the CDSCO. The license ensures that the manufacturer meets the safety and quality standards, thus, guaranteeing the fidelity and the clinical effectiveness of the manufactured medical device.

Moreover, they are designed to protect consumers and patients from substandard and potentially dangerous products and devices.

Steps to Obtain a CDSCO Manufacturing License for ENT Microsurgical Carbon Dioxide Laser

  1. Prepare necessary documentation, including the Device Master File, Quality Management Certificate, Device Details, Site details, amongst others.
  2. Submit the completed application and required documentation.
  3. Follow the prescribed process of examination and evaluation by the authority.
  4. Upon approval, receive the manufacturing license.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Ear, Nose, and Throat Microsurgical Carbon Dioxide Laser as per Medical Device Rules, 2017?

The risk class of Ear, Nose, and Throat Microsurgical Carbon Dioxide Laser is Class C.

Q2. What license is needed to manufacture Ear, Nose, and Throat Microsurgical Carbon Dioxide Laser?

To manufacture this device, an MD9 license is required.

Q3. What is the fee for MD9 license for Ear, Nose, and Throat Microsurgical CO2 Laser?

The fee for the MD9 license is Rs. 50,000, and there is an additional cost of Rs. 1,000 per product.

Q4. Who will issue the manufacturing license for Ear, Nose, and Throat Microsurgical Carbon Dioxide Laser?

As a class C device, the CDSCO HQ in New Delhi will issue the manufacturing license for the Ear, Nose, Throat Microsurgical Carbon Dioxide Laser.

Q5. Is repackaging of Ear, Nose, and Throat Microsurgical CO2 Laser considered manufacturing?

Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. In addition, medical devices are also drugs as per the definitions. Therefore, repackaging of Ear, Nose, and Throat Microsurgical Carbon Dioxide Laser is also considered manufacturing, requiring an MD9 license.

Conclusion

Navigating through the intricate process of getting a CDSCO manufacturing license can be challenging. At Pharmadocx Consultants, we specialize in assisting clients throughout this process, ensuring all pre-requisites are managed efficiently. For expert consultation or assistance, call us at +91-7404557227 or send an email to [email protected]. We're here to make your journey easier.

For more information about the MD9 license, follow this link.

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