• 2022-06-29 01:41:00

The TGA has given a presentation about the evidence expectations for medical devices or surfaces with anti-viral or anti-microbial claims in the Australasian Society for Biomaterials and Tissue Engineering (ASBTE) Conference 2022. This presentation provided manufacturers and sponsors general insights on the subject of medical devices with anti-viral or anti-microbial claims before the device inclusion in the Australian Register of Therapeutic Goods (ARTG).

• 2022-06-29 01:29:59

Recently, software technology has made significant advances and has been used considerably more frequently for medical purposes. It can drive itself to infer a clinical judgment in addition to serving as a message informant. The number of software-based medical devices that are currently on the market has significantly increased as a result of such software improvements. Therefore, it is important to monitor patient safety appropriately.

• 2022-05-26 14:21:34

On March 29, 2022, the Vietnamese MOH hosted a virtual conference to provide clarity to the new Price Declaration Process and announced the establishment of a new online portal for license holders to declare prices. Accordingly, all medical devices must publish the price in the DMEC website before placing the product in the Vietnam market, effective from April 1st, 2022.

• 2022-05-26 14:17:56

The US FDA offers manufacturers an opportunity to interact with FDA's experts to speed up the necessary processes for breakthrough medical devices to enter the US market. As a result, manufacturers with breakthrough medical devices have several benefits in the premarket review phase and a prioritized submission review.

• 2022-05-26 14:08:10

A German manufacturer of innovative software and telemedicine applications in the field of ophthalmology is now looking for distribution and business partners in various Asian countries.

• 2022-05-26 13:57:18

PFDA extended the CMDN Requirement of Class B-D Non-Registrable products until March 2023. This will allow continue selling of the affected products in the country using a License to Operate as the requirement. In addition, PFDA shared draft regulations pertaining to the earlier released Abridged Route Evaluation and COVID-19 products using new technologies.

• 2022-05-26 13:54:50

The Malaysian Medical Devices Authority (MDA) has decided to replace the requirement for lot-to-lot variation testing for the approval of new lots of COVID-19 test kits with the requirement under the establishment's post-market duties and obligations. With these, the establishment need to notify MDA of any new lot of the test kit that will be placed in the market.

• 2022-05-26 13:49:52

Screening and inspection of the importation of medical devices are being carried out at the main entry points of malaysia. This is one of the mechanisms to curb the activities of importing medical devices without a valid license, registration or authorization.

• 2022-05-26 13:46:04

Japan's Adverse Event Glossary are amended to match with the IMDRF's terminologies.

• 2022-05-26 13:40:37

The National Public Procurement Agency, which is responsible for managing the government's “e-Katalog”, issued provision No. 122/2022 concerning the Procedures for Organizing Electronic Catalogues. This changed the previous “e-Katalog” mechanisms including MoH's Sectoral E-Katalog.