• 2020-03-16 06:50:01

Medical Devices (Amendment) Rules, 2020 has been newly issued to amend the Medical Devices Rules, 2017. Medical Devices (Amendment) Rules, 2020 will be effective 1st April 2020. All medical devices in India is now to be regulated as “drugs”.

• 2020-03-16 06:48:29

Medical Devices (Amendment) Rules, 2020 has been newly issued to amend the Medical Devices Rules, 2017, effective 1st April 2020. All medical devices in India is now to be regulated as “drugs”.

• 2020-03-16 06:46:58

It is Qualtech priority to deliver the most update and accurate news to our clients as well as performing as platform to all associated organization. OMETA is one of the organizations that has a lengthy association with Qualtech Corporation.

• 2020-03-16 06:42:41

醫療器械部門將繼續進行試驗，以研究對當地負責人（LRP）的可行性，該試驗將持續到2020年12月31日，以用於有限數量的II / III / IV級普通醫療器械的上市申請。

• 2020-03-16 06:38:53

Ministry of Health has issued a Circular letter number HK.02.02 / VI / 1465/2019 about withdrawal and elimination of medical devices that contain mercury from the market. This circular letter is addressed to Head of medical devices manufacturer and Head of medical device distributor in throughout Indonesia. They need to take several actions to help the withdrawal and elimination process of medical devices that contain mercury.

• 2020-03-16 06:34:36

根據印度尼西亞衛生部的適用法規，醫療器械必須經過印度尼西亞衛生部的評估過程，才能獲得銷售授權號。 該銷售授權號表示醫療設備已經過

• 2020-03-16 06:31:12

在最新的公告中，MDA宣布，未註冊的口罩此後將通過特殊通道進入市場。

• 2020-02-21 07:28:40

VN MOH發布了第03/2020號法令，以修訂第36和169號法令，該法令將於2020年1月1日生效。以下是與進口醫療設備有關的說明：經與第36和169號法令相比，Qualtech進行差異性說明。

• 2020-02-21 07:28:02

由於新型冠狀病毒性肺炎的流行及其對中國的影響，NMPA，當地檢測中心和臨床場所已被優先考慮在流行情況下緊急醫療設備的批准。 結果，普通案件的進展可能會延遲。

• 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。