• 2023-02-23 01:59:23

The statistics as of January 2023 regarding the coverage of designation codes by MDR/IVDR notified bodies has been published in the attachment.

• 2023-02-23 01:45:57

A pilot run for new requirements on the procurement of medical devices by the Department of Health (DH) will be implemented with effect from 1st October 2022. Under the pilot run, medical devices purchased by Department of Health should preferably be listed under MDACS.

• 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.

• 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.

• 2023-02-23 01:28:49

A consultation window for framework and implementation of the Cybersecurity Labelling Scheme for Medical Devices [CLS(MD)] was announced to be open for the public from January 23 to March 3, 2023.

• 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。

• 2023-02-23 01:23:58

Thai FDA has published a guidance, which aims to assist the justification status of Software as Medical Device (SaMD) as well as its risk classification for Thai FDA registration.

• 2023-02-22 11:03:38

According to US FDA's review request for devices, the digital therapy device to reduce sleep disturbance for psychiatric conditions, and the prognostic tests for assessment of liver-related disease progression, will require special control (Class II). Thus, in the future, the US FDA will refer to the class II level to review these two kinds of devices.

• 2023-01-20 09:12:04

在疫情逐步解封的情況下，準備好進入歐盟市場:了解現在MDR法規的變化! Qualtech將於2023年2月7日(週二)下午16:30 - 17:30 (GMT+8) 舉辦MDR法規網絡研討會，現誠摯邀請您參加本次研討會。

這將是一個絕佳機會，讓您迅速了解您該怎麼跨出下一步，將您的產品推得更廣!

• 2023-01-19 06:48:57

The development of medical devices is significantly influenced by the rapid pace of technology. While these cutting-edge devices may improve healthcare services, they also pose major risks to public health and safety. Due to this, regulatory agencies throughout the world have been continuously developing and updating their regulations to strengthen their management of product registration and mandate that applicants submit more detailed documentation. This article will cover the recently issued, upcoming, and influential worldwide medical device regulation updates for the year 2023 in various countries.