• 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 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 02:35:39

18 medical device industry standards have been approved and are now published. The number, name, scope of standards and date of implementation can be found in the attachment.

• 2022-07-26 11:26:52

According to the De Novo Classification request from the respective manufacturers, the US FDA reviewed the request for the following devices, Intravascular Bleed Monitor and Non-Implanted Electrical Stimulation Devices for Management of Premature Ejaculation. As a result, both types of products are now classified as Class II products rather than belong to products of Class III.

• 2022-07-26 11:24:21

PFDA issued FDA Circular No. 2022-003 that bans the production and all kinds of market exchanges, such as distribution, sale, and advertisement, for several mercury-added devices and related products for safety reasons.

• 2022-07-26 11:22:27

PFDA released a draft circular that provides the requirements for good storage and distribution practices for medical devices, to serve as guidelines for medical device establishments in the Philippines.