Feb 9 - 1:11
Since President Trump took office in January 2017, many policy changes that affect the medical device industry have been enacted– the latest one being the renegotiation of the North American Free Trade Agreement...
Feb 4 - 2:27
According to the interim report on the work of the Executive Working Group (EWG), the European Union and United States will work together to make sure their electronic database specifications for Unique Device...
Jan 23 - 7:14
After weeks of the government’s shutdown, the US Food and Drug Administration (FDA) has announced that more workers will be returning to work without pay. A large majority of these workers are inspectors or work to...
Jan 9 - 8:17
On Thursday December 27th, Health Canada detailed a new three-part method aimed to help safety, oversight and quality in the Canadian medical device market. This plan has come soon after the investigation of the...
Jan 8 - 8:08
The institution responsible for regulating medical devices in Canada is the Medical Devices Bureau (MDB) of the Therapeutic Products Directorate (TPD), a federal authority within Health Canada. TPD uses a Canadian...
Dec 19 - 8:16
The institution responsible for regulating medical devices in the United States is the Food and Drug Administration (FDA). The FDA uses a risk-based classification system, which classifies medical devices into the...
