The U.S. Food and Drug Administration (FDA) categorizes medical devices into three classes based on the level of risk the devices pose to patients and users. Image Credit: IGORdeyka/Shutterstock.com ...

Changes affecting the approval of medical devices in Canada are coming. Health Canada has released a notice on Proposed Changes to the Guidance on Recognized Standards for Medical Devices along with a ...

Health Canada recently published draft regulations to address therapeutic product shortages in Canada. The Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Shortages and ...

Tofy Mussivand and a colleague inspect a microfluidics device used for cell electroporation and lysis. (Photo courtesy of MDI 2) MPMN: What is the role of the Medical Devices Innovation Institute at ...

A medical device is any appliance, apparatus, software, material, or other articles, which may be used in isolation or combination (as defined by the manufacturer) by individuals for a medical purpose ...

As part of its efforts to regulate the medical devices in the country, the Drugs Controller General (India) has issued a notice classifying 77 medical devices pertaining to oncology under the ...

Connected medical devices can improve patient care and operational efficiency. However, they also introduce new privacy and security risks. Healthcare providers should rethink their privacy and ...

South Korea’s medical device market is rapidly expanding, driven by technological innovations and increasing healthcare demands. As the market grows, understanding Korean medical device regulations is ...

As someone with over a decade of experience in the medical devices industry, I have seen how this market has transformed healthcare. The global medical devices market is estimated at USD 586.20 ...

Once a medical device is brought to market, FDA surveillance of its safety continues. “To facilitate incremental improvements in safety and effectiveness, the FDA allows manufacturers to modify ...