• 2021-08-26 12:58:20

In July, MOH released two Official Dispatches as guidance on registration routes and document preparation to import SARS-CoV-2 IVD medical devices and biologicals, especially SASR-CoV-2 Antigen Rapid Test Kit (RTK).

• 2021-08-26 11:57:56

The MDA has published new guidelines for temporary conditional approval for the COVID-19 self-test kit (COVID-19 RTK), which explains the application procedure and requirements that need to be followed by the establishment.

• 2021-08-02 06:20:55

Consistent with the new guidance published in February 2021 governing the risk- classification, technical documentation requirements, fee schedule and transition plan for medical device registration, respectively announced for medical device manufacturing and importation exemption for certain medical under Medical Device Act 2008 Section 27 (1). The announcement aims to balance medical device distribution brought about by the significant changes in regulation.

• 2021-08-02 06:16:13

Thai FDA progressively issues series of guidelines to enhance the new medical device act. This month will be focusing on the latest requirement on medical device manufacturing, importation, and distribution records or report preparation.

• 2021-03-22 06:57:43

Department of Medical Equipment and Constructions issued a written to provide instructions for registration of imported medical equipment product on February 9th, 2021.

• 2020-12-24 10:59:21

In the past Thai FDA had perpetually notified manufacturers / importer / distributors regarding the acute adverse effect of powdered surgical gloves to end-users or patients. Now, the Thai FDA has officially announced the prohibition of manufacturing, importation or sale of powdered surgical gloves, to ensure safety control to end-users or patients and prevention of adverse effect from the use of powdered surgical gloves.

• 2020-11-27 02:07:10

This announcement applies to all registrants of foreign Class II and Class III medical devices that have been registered in China, through foreign manufacturers established in China.

• 2020-10-19 09:48:24

Food and Drug Administration has announced sets of documentation required for Licensed Medical Device Manufacturing / Import License Renewal and Notified Medical Device Manufacturing / Import License Renewal that will expire in December 31st, 2020.

• 2020-09-15 08:44:25

Thailand’s Ministry of Public Health has announced a set of medical device definition for manufacturers and importers to follow when registering their medical device according to risk-based classification, to gradually endorse the transition of Thailand away from policy-based classification.

• 2020-08-13 09:07:56

Covid-19 pandemic has changed the landscape of the medical device markets drastically. In this article, we explore the shifts in supply and demand and bring up an overview of the key areas that have either been positively or negatively impacted.