• 2023-03-29 10:01:23

您是不是正在找尋一條進入各個亞洲市場的通路？
是不是想要簡單明瞭地取得各個東協國家之間的法規差異？
您是否有留意到東協醫療器材指令(ASEAN Medical Device Directive)將在進入多個東協國家之前予以簡化審查流程的機會？
想要了解更多、更廣、更全面的東協國家法規與市場資訊嗎？一同加入Qualtech的東協法規更新的線上研討會吧！研討會預計將於2023年4月28日下午4:00至5:30舉行，俗話說機會是留給有準備的人，所以，別錯過這次的精彩活動！

• 2023-02-23 02:33:41

Qualtech, in cooperation with Mr. Arkan Zwick of Austrian Manufacturer Croma-Pharma GmbH, have organized a webinar on the important updates pertaining to the EU MDR on February 7, 2023. Topics discussed include the European Commission's Proposal to extend the MDR transition period as well as the validity of MDD certifications, and our suggestions regarding the critical steps to be taken in order to smoothly obtain approval under the MDR. The content of the webinar has been briefly summarized in this article.

• 2023-01-19 06:29:59

自從2019年疫情爆發之後，2022年是睽違3年的首次臺灣邊境解封的一年!因此，這次在年末時，我們特別邀請了在東南亞、日本的同事回到總部進行為期一周的法規訓練，也順道參加Qualtech的尾牙。
來自各個國家的人齊聚一堂，一起享受難得的歡樂時光，並參加法規資訊分享演討會與東南亞法規教育訓練，大家難得聚在臺北，一起實體的面對面交流與分享各式東南亞法規，也讓Qualtech團隊更加團結與茁壯。

• 2022-11-29 03:32:40

Qualtech introduced medical device regulations and the role of authorized representative in ASEAN in the seminar held by Tokyo University's association, which supports medical device innovation.

• 2022-10-25 03:47:11

The OMETA/Qualtech Webinar 2022 was held on September 29, featuring updates on regulations in Asia.

• 2022-02-18 07:20:17

As Qualtech offers Authorized Representative (License Holder) Services in 11 countries in Asia and Oceania, the following article outlines some of the benefits for foreign manufacturers associated with assigning a neutral 3rd party as their license holder. In addition, the product registration license conditions for the different ASEAN countries, as well as Taiwan, Japan, Hong Kong, Australia, and China are summarized, including license validity, license transfer possibilities etc.

• 2021-10-04 05:18:22

On September 17th, Qualtech hosted its Webinar on the subject of Japan Medical Device Registration to an international audience of MD manufacturers. During the event, the Qualtech team thoroughly explained the Japan registration process and elaborated on aspects such as registration timelines, product classifications, and consultation sessions with PMDA.

• 2021-08-02 06:36:08

On June 30th, Qualtech and ISS AG jointly hosted an online event informing far more than 100 different medical device manufacturers from all around the globe about China’s New Regulations. Qualtech’s team thereby detailed the important updates that the new RSAMD will bring, including the new obligations for product registrants under the nationwide adopted MAH system.

• 2021-08-02 06:26:52

On July 2nd, Qualtech had been invited to present and inform Japanese OMETA Members (Overseas Medical Equipment Technical Assistants) on the medical device regulation updates in Thailand, the Philippines, and Vietnam during the OMETA Online Seminar.

• 2021-06-29 11:23:58

On April 16th, Qualtech organized a webinar and guided participants through the Latest updates for medical device regulations in the Philippines, Thailand, and Malaysia. Our experts covered all the major topics and suggested details to pay attention to.