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CDSCO Manufacturing License for Automatic radiographic film processor

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is a significant government body in India committed to ensuring the safety, efficacy, and quality of medical devices. Acting as the central licensing authority, the CDSCO performs diverse roles such as regulating market authorization, post-market surveillance, and controlling the manufacturing practices within the medical devices industry.

In the realm of medical devices, a manufacturing license plays a crucial role in maintaining high standards of quality and safety. It ensures that the manufacturing processes comply with the requisite laws and regulations to avoid the production of substandard or counterfeit products.

Today, we're delving into the world of Automatic Radiographic Film Processors, remarkable devices that have greatly enhanced the scope and efficiency of diagnostic imaging techniques. You can find more information and register your medical devices at the CDSCO portal.

What is an Automatic Radiographic Film Processor?

An Automatic Radiographic Film Processor is an advanced medical device designed to automate the process of developing, fixing, washing, and drying radiographic films. These machines are instrumental in radiology departments, improving the efficiency of processing radiographic films used for medical purposes.

Radiographic procedures are an integral part of modern healthcare, providing valuable images of the human body, which inform and guide the treatment pathway. Automatic radiographic film processors expedite the process of converting these radiographic films into visible images for clinicians to analyze.

The Role of CDSCO in Medical Device Regulation

CDSCO, with its mission to safeguard and enhance public health, plays a vital role in the regulation of medical devices like automatic radiographic film processors. CDSCO has instituted a robust regulatory framework for medical devices, requiring medical device manufacturers to comply with stringent licensing regulations to ensure the safety and efficacy of their products.

How to Manufacture Automatic Radiographic Film Processors

The manufacturing of Automatic Radiographic Film Processors, like any other Class C medical device, requires adherence to specific standards and guidelines as stipulated by CDSCO. Compliance to set manufacturing practices, quality management systems, and efficient record-keeping are quintessential in securing a manufacturing license.

Fees for Manufacturing License for Automatic Radiographic Film Processors

In order to manufacture a Class C medical device like an Automatic Radiographic Film Processor, an MD9 license is required. The fees for securing an MD9 license are set at Rs 50,000 for the license and an additional fee of Rs 1000 per product.

Why is a Manufacturing License Necessary for Automatic Radiographic Film Processors?

Securing a manufacturing license is a mandate, neither a choice nor a recommendation. It sets the standard for quality manufacturing practices, helping ensure the safety and efficiency of medical devices. Furthermore, it provides credibility to the manufacturers while safeguarding consumers and patients from substandard products. Regulatory compliance plays a significant role in the healthcare sector, and a license is a testament to this adherence.

Steps to Obtain a CDSCO Manufacturing License for Automatic Radiographic Film Processor

  1. Preparatory Documentation: Prepare the necessary documents like the Device Master File, Quality Management Certificate, Device Details, Site details, etc.
  2. Application Submission: Submit the application and documents to CDSCO.
  3. Approval Process: Wait for CDSCO to review the submission and grant approval.
  4. Overcoming Challenges: Address any queries or objections raised by CDSCO to get the license.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Automatic Radiographic Film Processor as per Medical Device Rules, 2017?

A1. The Automatic Radiographic Film Processor falls under the Class C risk category as per Medical Device Rules, 2017.

Q2. What license is needed to manufacture Automatic Radiographic Film Processors?

A2. An MD9 license is required to manufacture Automatic Radiographic Film Processors.

Q3. What is the fee for an MD9 license for Automatic Radiographic Film Processors?

A3. The fee for an MD9 license is Rs. 50,000 for the license and an additional fee of Rs. 1,000 per product.

Q4. Who will issue the manufacturing license for Automatic Radiographic Film Processors?

A4. For Class C medical devices like the Automatic Radiographic Film Processor, the CDSCO HQ in New Delhi will issue the manufacturing license.

Q5. Is repackaging of Automatic Radiographic Film Processors considered manufacturing?

A5. Yes, as per Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing and by further definitions, medical devices are also considered drugs. The Medical Device Rules have been made under the provisions of Drug Act only and hence, repackaging of Automatic Radiographic Film Processor is considered manufacturing, requiring an MD9 license.

Conclusion

The process of securing a manufacturing license for an Automatic Radiographic Film Processor is undeniably complex but it is a necessary procedure to ensure quality and safety. You might need professional help navigating the procedure, and that's where Pharmadocx Consultants come in. For consultation or assistance regarding the licensing process, do not hesitate to reach out to us at "+91-7404557227" or email us at "[email protected]". For more detailed information on the MD9 license, visit this page on our website.

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