CDSCO Manufacturing License for Electrostatic x- ray imaging system

Introduction

The Central Drugs Standard Control Organization (CDSCO) stands as the apex national health authority responsible for ensuring the quality, safety, and efficacy of medical devices manufactured, distributed, and sold in India. Part of its key mandate includes the standardization and control of medical equipment, a pivotal function in maintaining high levels of healthcare delivery.

Manufacturing licenses form an essential cog in the medical device industry, ensuring that only equipment that meets set standards is availed to patients, practitioners, and institutions alike. They emphasize quality while mitigating the risks associated with substandard products.

Among the various devices that necessitate this licensing is the Electrostatic x-ray imaging system - a device gaining recognition for its involvement in the medical field for enhancing diagnosis and treatment. You can explore more about this and other devices on the CDSCO's portal: CDSCO's portal

• What is an Electrostatic x-ray imaging system?
• The Role of CDSCO in Medical Device Regulation
• How to manufacture an Electrostatic x-ray imaging system
• Fees for manufacturing license for Electrostatic x-ray Imaging System
• Why is a Manufacturing License Necessary for Electrostatic x-ray Imaging System?
• Steps to Obtain a CDSCO Manufacturing License for Electrostatic x-ray Imaging System
• Frequently Asked Questions (FAQs)
• Conclusion

What is an Electrostatic x-ray imaging system?

The Electrostatic x-ray imaging system is a specially designed device that uses a field of electrostatic energy across a semi-conductive plate or a gas-filled chamber. It artfully converts patterns of x-radiation into electrostatic images, and subsequently, into visible images, aiding in diagnosis and treatment.

Common uses of the system encompass a broad spectrum of healthcare including, but not limited to, orthopedics, radiology, and neurology. These procedures often involve detailed analysis and reporting on anomalies picked up on the x-ray images produced by the system.

The Role of CDSCO in Medical Device Regulation

The CDSCO serves a key role in the regulation of medical devices in India. It shapes the regulatory environment, enforcing the Medical Device Rules of 2017, and ensuring adherence by all stakeholders. The core mission of the organization is to safeguard and enhance public health in India by assuring safety, efficacy, and quality of drugs, cosmetics, and medical devices.

How to manufacture an Electrostatic x-ray imaging system

The process of manufacturing an Electrostatic x-ray imaging system is guided by specific regulations and quality control measures. It involves meticulous engineering and keen attention to radiation safety norms. The manufacturer must follow strict specifications and ensure consistency in quality to meet the required standards laid down by regulatory bodies like the CDSCO.

Fees for manufacturing license for Electrostatic x-ray Imaging System

Since the Electrostatic x-ray imaging system falls under the Class C risk category, the MD9 license is required for its manufacture. The fees for this license amount to Rs. 50,000, with an additional cost of Rs. 1,000 per product.

Why is a Manufacturing License Necessary for Electrostatic x-ray Imaging System?

Obtaining a manufacturing license is a mandatory requirement for public health safety purposes. It aids in ensuring quality and safety in the production of the Electrostatic x-ray imaging system. Furthermore, it assures regulatory compliance in the healthcare sector while protecting consumers and patients from potential hazards in substandard products.

Steps to Obtain a CDSCO Manufacturing License for Electrostatic x-ray Imaging System

1. Preparations involving collecting required documents like Device Master File, Quality Management Certificate, Device Details, Site details etc.,
2. Application submission through the prescribed channels.
3. Guiding the application through the approval process.
4. Managing common challenges like documentation issues.

For obtaining a Class C risk license (MD9), please refer to the full details: CDSCO MD9 license

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Electrostatic x-ray Imaging System as per Medical Device Rules, 2017?

Class C.

Q2. What license is needed to manufacture Electrostatic x-ray Imaging System?

MD9 license is required.

Q3. What is fees for MD9 license for Electrostatic x-ray Imaging System?

Rs. 50,000 for the license and Rs. 1,000 per product.

Q4. Who will issue manufacturing license for Electrostatic x-ray Imaging System?

CDSCO Headquarters in New Delhi will issue the license.

Q5. Is repackaging of Electrostatic x-ray Imaging System considered manufacturing?

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 drugs. Medical Device Rules have been made under the provisions of Drug Act only and hence repackaging of Electrostatic x-ray Imaging System is also considered manufacturing requiring a license on MD9.

Conclusion

Understanding the dynamics of CDSCO Medical Device Licenses can be a complex task. Hence, it's always advisable to seek expert consultation. We at Pharmadocx Consultants offer expert services around CDSCO licensing & processes understanding. Feel free to reach us on our website Pharmadocx Consultants, call us on "+91-7404557227" or email at [email protected].