Jan 19 - 11:46
Medical device regulations tend to vary substantially from region to region as virtually every country has its own set of rules that manufacturers must comply with in order to bring a device to market. These...
Dec 25 - 12:50
Medical device regulations tend to vary substantially from region to region as virtually every country has its own set of rules that manufacturers must comply with in order to bring a device to market. These...
Aug 7 - 7:29
India’s health ministry, the Central Drugs Standard Control Organization (CDSCO), has amended its Medical Devices Rules 2017 to simplify the approval process for in-vitro diagnostic (IVD) devices. All...
Jul 9 - 7:16
Although the European Medical Devices Regulation (MDR) will not go into full effect until 2022, if your medical device company does business in the European Union, you may need to modify your labeling before then. The...
Mar 14 - 9:02
On May 5th, 2017 the European Union Medical Device Regulation (EU MDR) was officially published and was entered into force on May 26th, 2017. The new regulation, which is binding in its entirety, will have a direct...
Mar 8 - 3:07
In early March 2017, the European Council unanimously adopted the final texts of Medical Device Regulations (MDR) and In Vitro Diagnostics Regulations (IVDR). The European parliament will vote on the regulations in...
