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CDSCO Manufacturing License for Radiographic film/cassette changer programmer

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Introduction

The Central Drugs Standard Control Organization (CDSCO) plays a critical role in regulating the Indian medical industry. The organization is responsible for ensuring the quality, efficacy, and safety of medical devices produced within and imported into the country. CDSCO is the apex drug control authority that exercises relentless and comprehensive control over the manufacturing, distribution, sale, and import of medical devices and drugs.

In the context of the medical device industry, manufacturing licenses issued by CDSCO are of paramount importance. These licenses serve as an affirmation of adherence to safety guidelines, quality production, and operational efficiency. The issuance of manufacturing licenses upholds the integrity of the medical device industry by ensuring the products meet all predefined standards of operation and safety.

Today, we will focus on Radiographic Film/Cassette Changer Programmer, a class B medical device. Our discussion will shed light on the rigorous protocols and steps involved in obtaining a CDSCO manufacturing license for this device.

To explore further details about the CDSCO and its different functions, please visit CDSCO's portal.

What is Radiographic Film/Cassette Changer Programmer?

Radiographic Film or Cassette Changer Programmer is a specialized medical device used in medical radiography, which controls the operations of a film or cassette changer during serial medical radiography. Medical radiography involves the capturing of body images for the diagnosis of diseases or injury. The device plays a vital role in facilitating smooth, efficient, and precise operations during radiographic procedures.

This device is commonly used in numerous medical facilities, including hospitals, clinics, and diagnostic centers. It is integral to procedures like fluoroscopy and medical imaging that involve the use of radiographs.

The Role of CDSCO in Medical Device Regulation

With a vision to safeguard and enhance public health in India, CDSCO has established an extensive regulatory framework for medical devices. Over the years, the organization has put forth rigorous guidelines and conducted countless inspections to ensure that every medical device manufactured or imported into the country meets the highest standards of safety, efficacy, and quality.

CDSCO's regulatory framework establishes the risk-based classification of medical devices into four categories: Class A, B, C, and D, with Class A being the least risky, and Class D being the most. This classification plays a key role in determining the type of manufacturing license required.

How to manufacture Radiographic Film/Cassette Changer Programmer

A manufacturing process of Radiographic Film/Cassette Changer Programmer involves multiple intricate steps including design mechanism, hardware and software development, implementation, testing, and execution stages. It abides by stringent safety and quality protocols as per CDSCO's requirements.

Fees for manufacturing license for Radiographic Film/Cassette Changer Programmer

For manufacturing a class B medical device like Radiographic Film/Cassette Changer Programmer, an MD5 license is required. The fee for an MD5 license is Rs. 5,000. Along with it, a fee of Rs. 500 needs to be paid per product manufactured.

Why is a Manufacturing License Necessary for Radiographic Film/Cassette Changer Programmer?

The acquisition of a manufacturing license for Radiographic Film/Cassette Changer Programmer is mandatory. This license testifies the device's adherence to quality and safety standards, making it reliable for medical use. Regulatory compliance in the healthcare sector is crucial as it safeguards consumers and patients from substandard products. This aspects is even more important considering the device's role in radiography, which is critical for accurate diagnosis and treatment.

Steps to Obtain a CDSCO Manufacturing License for Radiographic Film/Cassette Changer Programmer

The following steps need to be undertaken to obtain a CDSCO manufacturing license:

  1. Procure essential documents including Device Master File, Quality Management Certificate, Device Details, Site details, etc.
  2. Submit an application with requisite documents.
  3. Wait for the review and approval of the application.
  4. Resolve any issues or queries raised during the approval process.

For a comprehensive understanding of the licensing process, visit our guide for MD5 license.

Frequently Asked Questions (FAQs)

Q1. What is risk class of Radiographic Film/Cassette Changer Programmer as per Medical Device Rules, 2017?

A1. Radiographic Film/Cassette Changer Programmer is classified under risk class B as per the Medical Device Rules, 2017.

Q2. What license in needed to manufacture Radiographic Film/Cassette Changer Programmer?

A2. An MD5 license is required to manufacture a Radiographic Film/Cassette Changer Programmer.

Q3. What is fees for MD5 license for Radiographic Film/Cassette Changer Programmer?

A3. The fee for an MD5 license is Rs. 5,000 and an additional Rs. 500 per product is also applicable.

Q4. Who will issue manufacturing license for Radiographic Film/Cassette Changer Programmer?

A4. For class B devices like Radiographic Film/Cassette Changer Programmer, the state FDA will issue the license.

Q5. Is repackaging of Radiographic Film/Cassette Changer Programmer considered manufacturing?

A5. Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of medical devices, including a Radiographic Film/Cassette Changer Programmer, is considered manufacturing. Thus, requiring a license on MD5.

Conclusion

Knowing the importance and process of obtaining a CDSCO manufacturing license for a Radiographic Film/Cassette Changer Programmer is necessary for manufacturers in the medical industry. However, the procedure might seem extensive and overwhelming.

That's why we, at Pharmadocx Consultants, are here to assist you. Ensure hassle-free and smooth licensing process with our experienced team. Feel free to get in touch at "+91-7404557227" or email us at "[email protected]". We're just a call or email away!

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