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CDSCO Manufacturing License for Diagnostic x-ray beam-limiting device

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is the apex regulatory body in India, responsible for ensuring the safety, efficacy, and quality of medical devices. The CDSCO plays a crucial role in the healthcare system by regulating the manufacture, import, distribution, and sale of medical devices in the country. Its key responsibilities include laying down standards, approving products, drawing regulatory measures, and enforcing quality compliance.

Manufacturing licenses are of immense importance in the medical device industry as they ensure that manufacturers adopt safe practices and adhere to stringent quality standards, which in turn warrants patient safety.

One such product that requires a manufacturing license is the Diagnostic x-ray beam-limiting device. This device has significant medical implications, especially in radiology and plays a vital role in diagnosing several medical conditions while minimising exposure to radiation.

For more information on the CDSCO and its role in regulating medical devices, please visit their potential portal.

What is Diagnostic x-ray beam-limiting device?

A Diagnostic x-ray beam-limiting device is a type of device intended to restrict the dimensions of a diagnostic x-ray field, reducing unnecessary exposure to radiation during diagnostic procedures. The device achieves this by limiting the size of the primary x-ray beam with equipment such as a collimator, cone, or an aperture.

These devices are commonly used in radiology departments, particularly for diagnostic imaging procedures, to enhance patient safety by controlling the radiation exposure.

The Role of CDSCO in Medical Device Regulation

The CDSCO, with its mission to safeguard and enhance public health in the country, has been instrumental in setting up a robust and dynamic regulatory framework for medical devices. The framework encompasses standards for manufacture, import, and distribution premised on international best practices.

CDSCO's medical device regulations are aimed at prioritising patient safety by ensuring the devices' performance and effectiveness through an orderly certification and license acquisition process.

How to manufacture Diagnostic x-ray beam-limiting device

The manufacturing of a Diagnostic x-ray beam-limiting device requires adherence to stringent regulations laid down by the CDSCO. As the risk class of this device is C, the manufacturer needs to obtain an MD9 license.

Fees for manufacturing license for Diagnostic x-ray beam-limiting device

The fees for procuring an MD9 License for the manufacturing of the Diagnostic x-ray beam-limiting device are Rs. 50,000 for the license, and there is also an additional charge of Rs. 1,000 per product.

Why is a Manufacturing License Necessary for Diagnostic x-ray beam-limiting device?

Possessing a manufacturing license is mandatory for the Diagnostic x-ray beam-limiting device due to several factors. Firstly, it ensures quality and safety in the production of the medical device. Secondly, a manufacturing license signifies the manufacturer's compliance to the regulatory guidelines, which is vital for maintaining standards in the healthcare sector. Lastly, the license serves as a protective measure for consumers and patients against substandard products.

Steps to Obtain a CDSCO Manufacturing License for Diagnostic x-ray beam-limiting device

  1. Submit the required documents, including the Device Master File, Quality Management Certificate, Device Details, and Site details.
  2. How's function with CDSCO to evaluate your application thoroughly before granting approval.
  3. Receive the license. It is essential to comprehend the requirements of this process to overcome common challenges.
  4. Stay current with changes in regulatory guidelines to maintain compliance.

FAQs

  1. What is the risk class of Diagnostic x-ray beam-limiting device as per Medical Device Rules, 2017?
    It falls under Risk Class C.
  2. What license is needed to manufacture Diagnostic x-ray beam-limiting device?
    An MD9 license is required.
  3. What is the fee for an MD9 license for Diagnostic x-ray beam-limiting device?
    The fee for an MD9 license is Rs. 50,000, with an additional charge of Rs. 1,000 per product.
  4. Who will issue the manufacturing license for Diagnostic x-ray beam-limiting device?
    The license will be issued by the CDSCO HQ in New Delhi.
  5. Is repackaging of Diagnostic x-ray beam-limiting device considered manufacturing?
    Yes, as per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is considered manufacturing. Medical Device Rules have been made under the provisions of the Drug Act, so repackaging of Diagnostic x-ray beam-limiting device also requires an MD9 license.

Conclusion

This blog post has elucidated the key details regarding acquiring a manufacturing license for the Diagnostic x-ray beam-limiting device in India. For meticulous guidance through the licensing process, feel free to reach out to the Pharmadocx Consultants, call on +91-7404557227, or send an email to [email protected].

For detailed information on the MD9 license, please visit this link.

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