• 2022-07-26 10:56:21

China's National Medical Products Administration (NMPA) has issued guidance on nomenclature of generic name for 6 subcategories.

• 2022-03-25 10:23:24

In December 2018, TGA has announced that there will be an adjustment of Surgical Mesh Devices to transform from medium risk (Class IIb) to high-risk devices (Class III), in order to meet the highest levels of safety, quality and clinical performance.
Sponsors were given three years to comply with the changes, and from 1 December 2021 onwards TGA has already commenced on cancelling surgical mesh devices in the ARTG as Class IIb entries, who do not have obtained an appropriate conformity assessment certificate for Class III devices prior to the set deadline, or within six months of the conformity assessment certificate for the Class III device being issued.
TGA has listed out 3 different tables, categorising meshes that are eligible for transition, approved surgical mesh devices, and existing Class III surgical mesh devices. This is to inform medical practitioners and hospitals of potential supply disruption of some surgical mesh devices from 1st December 2021, and to provide alternative sources of supply.

• 2021-05-22 03:30:32

In line with the risk classification transition, the Thai FDA has withdrawn the Ministry of Public Health’s exemption notice on surgical gowns, isolation gowns/coverall, disposable surgical masks, and disposable surgical masks N95, under Special Registration Route. Manufacturers must now apply the procedure according to the recently released risk-based classification requirements consistent with the ASEAN MDD.

• 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.

• 2020-12-24 10:54:11

Thai FDA has recently announced a list of standards to be complied by disposable surgical masks, upon making a set of COVID-19 related medical devices announcement.

• 2020-10-21 01:42:37

Food and Drug Administration urgently announced certain control measures for powdered surgical gloves regarding the technical issues of the powder used in manufacturing process which may cause serious adverse effect to end-users or patients.

• 2020-03-16 06:34:36

In accordance with applicable regulations of MOH Indonesia, medical devices must go through an assessment process by the MOH Indonesia to obtain a marketing authorization number. This marketing authorization number means that the medical devices have been declared safe and efficacy.