• 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。

• 2023-01-19 06:20:26

Most medical devices included in the Australian Register of Therapeutic Goods (ARTG) are supported by an obtained EU MDD certification and may need to transition to the new EU MDR in order to continue to be supplied in Australia.

Yet, many manufacturers are currently dealing with challenges regarding the switch from the EU MDD to the EU MDR. This includes additional requirements for the quality management systems (QMS) of the manufacturer, requiring higher standards in the clinical report to support the patient safety when using the medical device, classification rules changes, and other detailed technical document requirements.

• 2023-01-19 06:07:49

In order to support the supply of antigen testing reagents for COVID-19, NMPA has made related announcements.

• 2023-01-19 06:04:35

The NMPA drafted the <Announcement on the Third Batch of Implementation of the UDI of Medical Devices (Draft for Comment)> and is now soliciting opinions publicly.

• 2023-01-19 05:55:29

Two regulations for medical devices have been implemented in the month of December 2022. One is a common specification for the groups of products without an intended medical purpose, the other are rules regarding reclassification of groups of certain active products without an intended medical purpose.

• 2023-01-19 05:51:33

This guidance is to assist manufacturers to implement the legal requirements related to the Periodic Safety Update Report (PSUR), which has been introduced in Article 86 of the MDR. This guidance provides the detailed information of the PSUR requirements and the related templates.

• 2023-01-19 05:49:15

It is announced that the MDA amended the terms of the establishment license granted under section 15 of Act 737 in accordance with Act 20's provisions. At least 90 days before the license expires, the establishments must submit an application to the Authority for a renewal.

• 2023-01-19 02:06:31

The Singaporean Health Sciences Authority (HSA) has updated the regulatory guidelines for Laboratory Developed Tests (LDTs) based on the feedback from the stakeholders for the draft that was published for consultation last July 12 - August 12, 2022. The finalized version is coded as GL – 08 R1 with the title of “Regulatory Guidelines for Laboratory Developed Tests (LDTs)”and will be effective on March 1, 2023.

• 2023-01-19 01:28:15

As we are easing into the first quarter of 2023, we are thus simultaneously entering into the last phase of Thai FDA grace period regarding the transition to the risk-classification approach. Thus, Thai FDA has published a summary of the medical device categories on their official website instructing medical device registration via Full CSDT submission and Partial 2 Submission route.

• 2022-12-27 10:11:55

A Quality Management System (QMS) is used by a company or manufacturer as a set of policies, procedures, and processes. It provides a constructive handling and coordination of a business by continual improvements in effectiveness and efficiency. In this article, the QMS requirements for medical device manufacturer, company or organization on different countries will be explored.