SaMD and SiMD: The Differences and Applicable Regulations

by Sudhriti M | Jun 3, 2024 | Medical Device

New-age technology and software are revolutionizing healthcare. Currently, software is being used to monitor, diagnose, prevent, manage, and even treat diseases. Software used in healthcare industry are available in different types and forms.  The two main categories...

CDSCO License Retention Fee: Mandatory for License Validity

by Sudhriti M | Jun 2, 2024 | Medical Device, Medical Device License Requirements

In a recent circular, dated 15.5.24, CDSCO has issued a reminder for license or registration retention under MDR, 2017. This reminder for license and registration certificate renewal requirements is intended for medical device manufacturers, importers, and testing...

Medical Device Process Validation Assures the Device Quality

by Sudhriti M | Jun 1, 2024 | Medical Device

Regulatory bodies require medical device manufacturers to confirm whether the finished product meets the set regulatory benchmark. Manufacturers need to have strict quality control systems to ensure the devices being manufactured comply with safety and quality...

CDSCO Registration : Start Medical Device Business in India Without CDSCO License

by Sudhriti M | May 31, 2024 | Medical Device

Medical devices form the backbone of the healthcare sector. They are used to perform real time diagnosis of medical conditions as well as treat and monitor them. Medical devices industry is a booming sector in India. There is a high unmet demand for affordable,...

Medical Device Grouping: Simplifying CDSCO License Application

by Sudhriti M | May 30, 2024 | Medical Device

Medical device grouping has been introduced to enhance the license application process in India. Grouping of medical devices expedites and simplifies the CDSCO registration and license application process. In this blog, we will delve into the grouping of medical...