• 2022-09-27 08:51:16

Australia's Therapeutic Goods Administration (TGA) provides a pathway to applicants to have the opportunity to be determined as a priority applicant for their medical devices. This means, that the application will be recognised as the 'front-of-queue' priority throughout the relevant assessment processes.

• 2022-09-27 08:40:58

Matters concerning the filing of Class I medical devices (including Class I IVDs) are announced. The relevant documents are attached as well.

• 2022-09-27 08:23:11

A pilot run for the new requirement on the procurement of medical devices by the Department of Health will be implemented with effect from 1st October 2022. Under the pilot run, medical devices purchased by the Department of Health should preferably be listed under MDACS.

• 2022-09-27 07:58:07

Effective since 6th July 2022, Indonesia’s Ministry of Health has issued Ministry of Health Decree number HK.01.07/MENKES/1258/2022 concerning Substitution of Imported Medical Devices with Domestic Medical Devices in the Electronic Catalog / e-Katalog of the Health Sector that implement the freeze/ unfreeze mechanisms.

• 2022-09-27 06:12:22

The Vietnam Ministry of Health released Circular No. 05/2022/TT-BYT on August 1, 2022, detailing a number of articles of the Government's Decree No. 98/2021/ND-CP dated November 8, 2021, on the management of medical devices.

• 2022-08-30 03:43:54

PFDA issues the updated regulation for Medical Radiation Devices that aims to provide guidelines for the importation of radiation devices used for both medical and non-medical applications in accordance to AO 2018-0002.

• 2022-08-30 03:36:34

The Malaysian Medical Device Authority (MDA) issued the Fifth Edition Guidance for Labeling on Registered Medical Devices. The document's goal is to provide manufacturers and authorized representatives with a guidance on the content of medical device labelling.

• 2022-08-30 03:32:59

Starting July 1, 2022, MDA fully implemented the Medical Device (Responsibility & Establishment) Regulations.

• 2022-08-30 02:59:24

China's Center for Medical Device Evaluation (CMDE) has released recommended paths for clinical evaluation for a number of products, which fall in the subcategories 01, 04, 07-10, 19, as well as 21 of the Category of Medical Devices.

• 2022-08-30 02:54:29

The Center for Medical Device Evaluation (CMDE) has formulated “Technical Guidelines for the Compliance of the <Basic Principles of Medical Device Safety and Performance>".