• 2020-02-15 08:23:38

2013年11月19日，舉行了研究人員會議，以啟動用於CFDA註冊目的的III類醫療器械Dermal Filler的臨床試驗。

• 2020-02-15 09:10:35

Qualtech TFDA經理張敏娜應邀參加由新加坡製造業聯合會和DH RegSys Pte Ltd舉辦的新加坡研討會“了解台灣的醫療器械監管框架”。

• 2020-02-15 08:52:37

Qualtech受OMEGA（海外醫療設備技術助理）的邀請在台灣和中國大陸進行法規註冊演講。

• 2020-02-15 08:44:50

2013年6月25日至6月26日，Qualtech TFDA經理張敏娜（Juliana Chang）應新加坡製造業聯合會和DH RegSys Pte Ltd的邀請在新加坡進行了TFDA培訓。

• 2020-02-15 09:00:48

成功的論壇已於2013年4月15日在台北舉行。

• 2020-02-15 09:12:24

我們在新加坡的辦公室正式開放。

• 2020-02-15 09:11:48

Qualtech於2012年12月底成功獲得了CFDA第三類植入物產品的第二份許可證。

• 2024-06-19 09:35:10

The rise of connected medical devices has revolutionized healthcare, but it has also introduced new cybersecurity challenges. To address these concerns, Singapore has implemented the CLS(MD) scheme, a collaborative effort to enhance medical device cybersecurity.
This article explores the latest updates on the CLS(MD) Sandbox program, its background, key details, and how medical device manufacturers can benefit from participation.

• 2021-10-27 07:43:08

Every once in a while, Japanese Ministry of Health, Labor and Welfare (MHLW) issues notices to announce evaluation principles of “Next-Generation Medical Devices,” to accelerate review and approval process of new medical devices which has high demands and high feasibility of product realization. Since 2008, there have been 27 issuances by MHLW listed in the end of this article.

In this article, we will introduce list of “Next-Generation Medical Devices” that were announced in the past notices as well as were one of the notices issued in September of 2020, “Evaluation Index of Medical Devices for Home Medical Care”.

• 2021-10-27 07:34:31

Every once in a while, Japanese Ministry of Health, Labor and Welfare (MHLW) issues notices to announce evaluation principles of “Next-Generation Medical Devices,” to accelerate review and approval process of new medical devices which has high demands and high feasibility of product realization. Since 2008, there have been 27 issuances by MHLW listed in the end of this article.

In this article, we will introduce list of “Next-Generation Medical Devices” that were announced in the past notices as well as were one of the notices issued in September of 2020, “Evaluation Index of Medical Devices for Home Medical Care”.