CDSCO Manufacturing License for Mammographic x-ray system

Introduction

The Central Drugs Standard Control Organization (CDSCO) plays a vital role in protecting, promoting, and maintaining public health in India. Being the national regulatory authority, it is responsible for the approval of drugs, medical devices, and cosmetics. The CDSCO's primary functions include regulatory control over the manufacturing, import, and distribution of drugs, approving new drugs, and conducting clinical trials. It plays an irreplaceable role in setting standards of drugs, cosmetics, and medical devices in the country.

Having a manufacturing license is particularly crucial in the medical device industry. An official license certifies that the company complies with all regulatory standards which guarantees the quality, safety, and effectiveness of the product manufactured, which in this case is the Mammographic x-ray system.

The Mammographic x-ray system holds significant importance in the field of radiology. It is used predominantly to screen and diagnose abnormalities in the breast tissues, aiding in the early detection of breast cancer. Furthermore, you can visit the CDSCO’s official portal for more information.

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

What is a Mammographic x-ray system?

A Mammographic x-ray system is a diagnostic medical device used to take radiographic images of the breast. The purpose of the mammographic x-ray system, also known as mammography, is to early detect and diagnose abnormalities in the breast tissues including but not limited to breast cancer.

Mammographic x-ray systems are commonly used in screening procedures for early detection of breast cancer, especially in women over 40 or those with a family history of breast cancer. It can detect changes in breast tissue that may not be felt during a physical examination.

The Role of CDSCO in Medical Device Regulation

The Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health & Family Welfare, Government of India, is the principal authority for the regulation of medical devices in India. CDSCO ensures that the medical devices sold in the market meet the required safety and performance standards.

The regulatory framework of CDSCO for medical devices is designed progressively to ensure patient safety while promoting the growth of the medical device industry. CDSCO classifies medical devices into four risk classes - A, B, C, and D, with class A being the lowest risk while class D being the highest.

How to manufacture a Mammographic x-ray system

The manufacturing process of a Mammographic x-ray system involves several stages. It begins with the design and development phase, followed by the manufacturing phase, which includes the assembly of components, installation, and testing. This process is regulated by the CDSCO to ensure the safety and effectiveness of the system.

Fees for manufacturing license for Mammographic x-ray system

For manufacturing a Mammographic x-ray system which falls under the category of Class C medical devices, an MD9 license is necessary. The fees for MD9 is Rs. 50,000 for the license and Rs. 1,000 per product.

Why is a Manufacturing License Necessary for Mammographic x-ray system?

Obtaining a manufacturing license for the Mammographic x-ray system is mandatory under the CDSCO regulations. This certification maintains the quality assurance and safety of the device produced and also helps to establish trust among consumers.

Regulatory compliance is pivotal in the healthcare sector. It ensures that patients receive safe and effective healthcare services. Furthermore, ensuring that medical devices comply with regulatory standards protects medical professionals and patients from defective or substandard products.

Steps to Obtain a CDSCO Manufacturing License for Mammographic x-ray system

1. Prepare necessary documents such as Device Master File, Device Details, Quality Management Certificate, Site details etc.
2. Submit these documents to the CDSCO for review and approval.
3. The CDSCO will then carry out an inspection of the manufacturing facility.
4. Upon successful inspection, the CDSCO will issue a manufacturing license.

For more information, you can refer to this detailed guide on obtaining the MD9 Manufacturing license.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of Mammographic x-ray system as per Medical Device Rules, 2017?

The Mammographic x-ray system falls under the Class C risk category according to the Medical Device Rules, 2017.

Q2. What license is needed to manufacture Mammographic x-ray system?

To manufacture a Mammographic x-ray system, an MD9 license is needed.

Q3. What is the fee for MD9 license for Mammographic x-ray system?

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

Q4. Who will issue a manufacturing license for Mammographic x-ray system?

The manufacturing license for a Class C device like Mammographic x-ray system will be issued by CDSCO HQ in New Delhi.

Q5. Is repackaging of Mammographic x-ray 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 Mammographic x-ray system is also considered manufacturing requiring a license on MD9.

Conclusion

If you need any assistance regarding the licensing process, feel free to reach out to Pharmadocx Consultants, a trusted consultant for medical device licensing in India. You can call us directly on +91-7404557227 or drop an email at [email protected] for consultation or assistance.