Interested in selling your medical device in Singapore? Singapore is a leading healthcare destination in Asia and its regulatory system shares many similarities with the regulatory process in the European Union.
In order to commercialize in vitro diagnostic (IVD) devices in the European Union, a CE Mark certificate is needed.
貴社の医療機器のブラジルでの販売に興味をお持ちですか？ ブラジルの機器登録プロセスは確立されていますが、どちらかと言うと複雑です。
欧盟医疗器械数据库（Eudamed）是欧盟新医疗器械和IVD法规的重要组成部分。 Eudamed是一个数据库，用于根据医疗器械法规（MDR 2017/745）和体外诊断医疗器械法规（IVDR 2017/746）来监控器械的安全性和性能。 医疗器械业界渴望了解他们需要如何与Eudamed互动，以及他们的器械性能信息将如何被共享。
在本白皮书中，我们探讨了Eudamed的用途和功能，以及医疗器械公司将如何使用它。 您将学习到：
Europe is the world's second-largest medical device market with 500 million people, 20+ languages, 32 countries and (fortunately) only one approval process. This short video gives you a high level overview of the CE Marking process in Europe as it exists currently under the Medical Devices Directive (93/42/EEC).
Japan is the largest market for medical devices in Asia. Though Japan has less than one-tenth (1/10) the population of China, the Japanese spend more on healthcare. An aging population and high per-capita spending make it an attractive and potentially lucrative market for medical device manufacturers. Interested in entering this market?