The first major revision to device regulations since 2007 has been released and the changes are significant. Although the MDR won't take effect for a few years, smart companies are planning ahead to beat the crush of companies that will inevitably wait until the last minute, overwhelming EU Notified Bodies.

Taiwan is a high-income country with considerable healthcare expenditures. The country imports about 70% of its medical device supplies and approximately 99% of Taiwan’s population is covered by governmental National Health Insurance.

Israel is a small country with significant medical device needs. Medical devices in Israel are regulated by AMAR and the registration process relies on your device's market authorization in other key markets. However, you still need to complete some key steps and meet requirements before putting your device on the Israeli market.

White paper - Preparing to change your EU Notified BodyDie Übergangsfrist für die EU-Verordnung über Medizinprodukte (MDR 2017/745) beginnt bald.

The transition deadline for the European Medical Devices Regulation (MDR 2017/745) will be here soon and medical device companies are preparing to recertify under the new regulation. However, some manufacturers could face another obstacle: losing their Notified Body (NB).

Brazil’s medical device industry faced a number of challenges in recent years: a complex regulatory process created long delays for approvals and a tumultuous economic and political future presented uncertainties for foreign manufacturers.

Pages