CDSCO Manufacturing License for Radiographic film cassette

Introduction

The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory authority in the healthcare sector. It is responsible for the approval of new drugs, control over the quality of drugs, and the regulation of various other aspects of the pharmaceutical industry, including the licensing and manufacturing of medical devices. It is closely involved with the protection of public health in India, ensuring that safe and effective medical devices are available to patients.

The licensing and regulating of medical devices is a significant responsibility of the CDSCO - a function that ensures safety and efficacy in the Indian healthcare sector. One such device, the Radiographic Film Cassette, plays a vital role in diagnostic x-ray procedures in radiology, allowing for precision and accuracy in imaging data essential for appropriate diagnosis and treatment.

Refer to CDSCO's portal here for further details on the medical device licenses.

• What is a Radiographic Film Cassette?
• The Role of CDSCO in Medical Device Regulation
• How to Manufacture a Radiographic Film Cassette
• Fees for Manufacturing License for a Radiographic Film Cassette
• Why is a Manufacturing License Necessary for a Radiographic Film Cassette?
• Steps to Obtain a CDSCO Manufacturing License for a Radiographic Film Cassette
• Frequently Asked Questions (FAQs)
• Conclusion

What is a Radiographic Film Cassette?

A Radiographic film cassette is an imaging device intended for use during diagnostic x-ray procedures. It acts as an enclosure to hold a radiographic film in close contact with an x-ray intensifying screen. The cassette provides a light-proof exposure for direct display on the radiographic film, which is paramount for accurate reading of diagnostic x-ray images.

These cassettes are typically used in hospitals, diagnostic centers, and other clinical settings for various medical imaging procedures, importantly in radiology.

The Role of CDSCO in Medical Device Regulation

Originating as the Central Drugs Laboratory under the Drug Department, CDSCO has expanded into a diversified regulatory body for the healthcare sector in India. It plays a pivotal role in shaping national policies for drugs and pharmaceuticals and the subsequent enforcement of these rules and regulations.

CDSCO's regulatory framework for medical devices encompasses a vast range of products, from simpler devices to more complex innovations. A key part of its role lies in the classification of these devices into four risk classes: A, B, C, D - with Class A representing the lowest risk and Class D the highest. The Radiographic Film Cassette falls under Risk Class B.

How to Manufacture a Radiographic Film Cassette

The manufacturing of a Radiographic Film Cassette requires compliance with CDSCO guidelines to ensure safety and efficiency. This includes obtaining the appropriate manufacturing license, in this case - the MD5 license for Class B medical devices.

Fees for Manufacturing License for a Radiographic Film Cassette

The fees requisite for the MD5 license, suitable for Class B medical devices like the Radiographic Film Cassette, include Rs. 5,000 for the license and an additional fee of Rs. 500 per product.

Why is a Manufacturing License Necessary for a Radiographic Film Cassette?

Obtaining a manufacturing license for medical devices is mandatory under CDSCO regulations. This is critical in ensuring quality and safety in the production and subsequent use of these devices. Compliance with regulations is vital in the healthcare sector to uphold the highest possible standards of care and patient safety.

A manufacturing license protects consumers and patients from substandard products, ensuring that every product that reaches the market is of assured quality and efficacy.

Steps to Obtain a CDSCO Manufacturing License for a Radiographic Film Cassette

1. Necessary documents including the Device Master File, Quality Management Certificate, Device Details, and Site details, among others, must be duly prepared.
2. Follow the application process, from submission to approval, as per CDSCO guidelines.
3. Address common challenges that might arise during the process and overcome them timely.
4. Obtain the final approval for the license.

Visit this page for detailed steps and requirements for an MD5 license.

Frequently Asked Questions (FAQs)

1. Q: What is the risk class of a Radiographic Film Cassette as per Medical Device Rules, 2017?

   A: Radiographic Film Cassette falls under Class B.

2. Q: What license is needed to manufacture a Radiographic Film Cassette?

   A: An MD5 license is required for manufacturing a Radiographic Film Cassette.

3. Q: What is the fee for an MD5 license for a Radiographic Film Cassette?

   A: The fees for an MD5 license is Rs. 5,000 and Rs. 500 per product.

4. Q: Who will issue the manufacturing license for a Radiographic Film Cassette?

   A: For Class B devices such as Radiographic Film Cassette, the license will be issued by the state FDA.

5. Q: Is repackaging of a Radiographic Film Cassette considered manufacturing?

   A: Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging is considered manufacturing. Therefore, repackaging of a Radiographic Film Cassette also requires an MD5 license.

Conclusion

Navigating the process of obtaining medical device licenses can seem daunting with various guidelines, steps, and requirements. We at Pharmadocx Consultants are here to help you with this process, providing expertise and assistance to ensure a smooth pathway to obtaining your medical device license.

Reach out to us for consultation or assistance here or call us at "+91-7404557227". You can also email us at [email protected] with your queries or for further information. We look forward to assisting you with your licensing needs.