• 2022-07-26 11:03:38

Five years have passed since the adoption of the MDR. From the end of the transition period, medical devices not certified under the MDR will have no access to the EU market. Thus, it is essential for all manufacturers to apply to a notified body and comply with the MDR as soon as possible.

• 2022-06-29 02:14:40

MDCG 2022-6 provides clarifications on the concept of ‘significant changes in the design and intended purposes’ under IVDR Article 110(3). It concerns manufacturers of devices that are compliant with Directive 98/79/EC (IVDD) and that are placed on the market or put into service after 26th May 2022 during the transition period.

• 2022-06-29 02:11:11

MDCG 2022-5 is a guidance which provides elaboration of the borderline between medical devices and medicinal products, including relevant definitions and examples for these types of products, such as herbal products, substance-based devices and medical device and medicinal product combinations.

• 2022-05-26 13:46:04

Japan's Adverse Event Glossary are amended to match with the IMDRF's terminologies.

• 2021-12-27 05:35:39

The Japan Federation of Medical Devices Association (JFMDA) has arranged the Japanese “Adverse Event Glossary” and created a mapping chart to match with IMDRF's Adverse Event terminologies.

• 2021-06-29 11:30:23

On 25th June, Qualtech and ISS AG jointly hosted an enriching webinar session on the newly implemented Medical Device Regulation MDR (EU) 2017/745 (MDR) and the dynamic European medical device landscape. In this article, we are looking at the important points discussed.

• 2021-05-18 01:53:36

理工科技將於2021年5月25日舉辦針對歐盟MDR的線上研討會，歡迎有興趣的貴賓免費報名參加！

• 2020-09-15 06:35:40

MDCG已針對在MDR / IVDR下進行的監督審核中使用MDASP審核報告的情況，為指定機構發布了指南。 對於具有相似或等效要求的人員，積極的QMS符合性結果可能會導致對關注方面的關注減少。

• 2020-02-21 07:27:21

2020年1月8日是Qualtech為台灣客戶舉辦有關新的歐洲醫療器械法規（MDR）的廣泛研討會的日子。 該活動在2020年5月26日過渡期結束之前向與會者提供了有關MDR實施的最新信息。

• 2020-02-21 06:51:47

9月17日，國際醫療器械監管者論壇（IMDRF）通過了醫療器械臨床評估提案，並獲得了IMDRF成員的一致認可。 該建議由中國NMPA領導的醫療器械臨床評估工作組撰寫。