• 2020-12-23 02:21:33

MDA has announced a new search database, Medical Device Authority Register (MDAR).

• 2020-12-23 02:15:03

MDA has come up with a new guidance document incorporating the 2019 published Medical Device Advertisement Regulation.

• 2020-12-23 02:01:32

TFDA has recently announced a 3-stage schedule of implementing UDI system on labels of medical devices. Starting from June 1st, 2021, class 3 implantable medical devices are the first round of products that are required to comply with this regulation; followed by class 3 non-implantable medical devices starting from June 1st, 2022, and finally, class 2 medical devices starting from June 1st, 2023.

• 2020-12-23 01:53:56

To further develop a more practical and effective safety surveillance system, TFDA has set up regulations of serious adverse event reporting especially for medical devices. This article leads you into the main differences of the current and upcoming regulations.

• 2020-11-27 02:19:08

Compared to domestic and foreign listed products, novel medical devices with new designs, materials or processes, or scope of application and pose a high risk to humans should be approved for clinical trials before the trials can be conducted in China.

• 2020-11-27 02:14:19

From October 19, 2020 to August 31, 2021, China will have a pilot run of electronic registration certificates issuance for medical devices. It will entail newly approved pre-market domestic Class III, foreign Class II and Class III medical devices.

• 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.

• 2020-11-26 03:47:29

In 2020, National Public Procurement Agency (in Indonesia known as LKPP) has opened E-katalog registration for domestic medical device products and several medical products for handling Covid-19. Due to the Covid-19 pandemic, there are several stages in the E-katalog registration process which is carried out online, namely verification / clarification process. However, the price negotiation stage is still carried out face to face. There is also a possibility that e-katalog registration for imported medical products will be opened around this year.

• 2020-08-06 09:09:52

• 2021-10-27 07:43:08

Every once in a while, Japanese Ministry of Health, Labor and Welfare (MHLW) issues notices to announce evaluation principles of “Next-Generation Medical Devices,” to accelerate review and approval process of new medical devices which has high demands and high feasibility of product realization. Since 2008, there have been 27 issuances by MHLW listed in the end of this article.

In this article, we will introduce list of “Next-Generation Medical Devices” that were announced in the past notices as well as were one of the notices issued in September of 2020, “Evaluation Index of Medical Devices for Home Medical Care”.