• 2023-01-20 09:12:04

Enter EU market with confidence: Keep updated on MDR Regulation changes! Join Qualtech MDR webinar on 07 Feb 2023 (Tue) at 16:30 – 17:30 p.m. (GMT+8).

A perfect opportunity to prepare for the changes and minimize the impact on you.

• 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.

• 2023-01-19 06:29:59

Qualtech's internal Southeast Asia regulatory training and our End of the Year Party 2022 have been successfully completed. As the borders have gradually reopened and travel restrictions have been lifted, Qualtech has invited its members from the various ASEAN countries as well as from Japan to gather in our headquarter in Taipei. The accomplishments of the gathering include the exchange of regulatory information, the fostering of better communication, and the strengthening of our teamwork across the various Qualtech branch offices.

• 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.