最新消息

QT Activity: Summary of Qualtech's Webinar on the EU MDR Updates from February 7, 2023 – February/March 2023

QT Activity: Summary of Qualtech's Webinar on the EU MDR Updates from February 7, 2023 – February/March 2023

  • 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.

了解更多
China: NMPA Announcement on Issuing the "Regulations on Enterprises Implementing the Supervision and Management of Responsibilities for Medical Device Quality and Safety" (2022 No. 124) –February/March 2023

China: NMPA Announcement on Issuing the "Regulations on Enterprises Implementing the Supervision and Management of Responsibilities for Medical Device Quality and Safety" (2022 No. 124) –February/March 2023

  • 2023-02-23 02:05:29

In order to supervise medical device registrants taking the responsibilities for medical device quality and safety, NMPA has issued the so-called "Regulations on Enterprises Implementing the Supervision and Management of Responsibilities for Medical Device Quality and Safety".

了解更多
INDONESIA: Expansion of E-purchasing Access for Private Health Facilities Participating in the JKN (National Health Insurance Scheme) – February/March 2023

INDONESIA: Expansion of E-purchasing Access for Private Health Facilities Participating in the JKN (National Health Insurance Scheme) – February/March 2023

  • 2023-02-23 01:39:29

The Procurement Bureau of the Ministry of Health and the National Public Procurement Agency plan to expand E-purchasing access for private health facilities participating as National Health Insurance (in Indonesia known as JKN) providers for transactions of medical devices in the e-katalog starting from January 2023.

了解更多
MALAYSIA: MDA Announces New Guideline On How to Submit an Application for Registration of A Refurbished Medical Device – February/March 2023

MALAYSIA: MDA Announces New Guideline On How to Submit an Application for Registration of A Refurbished Medical Device – February/March 2023

  • 2023-02-23 01:35:01

The Medical Device Authority (MDA) published the First Edition Guideline Document “How To Submit An Application For Registration Of A Refurbished Medical Device” (MDA/GL/10) on January 11, 2023. The MDA created this guidance document to assist the industry and healthcare professionals in their efforts to comply with the Medical Device Act (Act 737) and its regulations.

了解更多
社會公益: 資助高雄市私立基督教山地育幼院

社會公益: 資助高雄市私立基督教山地育幼院

  • 2022-09-27 07:35:39

2000年Qualtech在臺北成立,其後在世界各地成立了多個據點,多年来Qualtech 除了始終堅持提供醫療器材的法規諮詢、產品註冊、臨床設計與執行、當地授權代理人、上市後追蹤等高品質與專業的服務之外,也不忘記屬於Qualtech的企業責任,正因為我們從事著與醫療相關的產業,我們更加著重於幫助與關愛弱勢團體。

了解更多
社會公益: 資助中國貧困的小朋友

社會公益: 資助中國貧困的小朋友

  • 2022-09-27 07:33:24

2000年Qualtech在臺北成立,其後在世界各地成立了多個據點,多年来Qualtech 除了始終堅持提供醫療器材的法規諮詢、產品註冊、臨床設計與執行、當地授權代理人、上市後追蹤等高品質與專業的服務之外,也不忘記屬於Qualtech的企業責任,正因為我們從事著與醫療相關的產業,我們更加著重於幫助與關愛弱勢團體。

了解更多