• 2020-04-14 02:16:06

MOH has stopped enforcing the depkes.go.id domain on all Ministry of Health websites. Thus, will be replaced by the kemkes.go.id domain.

• 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.

• 2020-02-21 06:56:04

In Indonesia, E-Katalog become the most popular platform for the public hospital or government related institution to find required medical device equipment. In October, Government invite Medical Device Company to submit an offering of Medical Devices and Household Health Supplies products to be included in E-Katalog.

• 2020-05-06 06:48:58

To enhance the efficiency of the registration process, NMPA sets up an online submission system. Local China agents of imported medical devices shall apply for an account within the system via Certificate Authority (CA) certificate. Further details are to be found below in this article.

• 2020-07-31 10:40:17

ThaiFDA is highly concerned with the health and the well-being of the people abrupt from the situation of PM.2.5 in Thailand. Respectively, the “Letter of Notification: Registration of Importer Establishment License and Registration of Medical Mask for Special Circumstance” was announced.

• 2020-05-06 06:04:19

Thai FDA is highly concerned with the health and the well-being of the people abrupt from the situation of PM.2.5 in Thailand. Respectively, the “Letter of Notification: Registration of Importer Establishment License and Registration of Medical Mask for Special Circumstance” was announced.

• 2020-05-06 05:10:35

In a recently issued revised guideline on How to Apply for Medical Device Registration Under Medical Device Act 2012 (Act 737), MDA specified that it can drop an ongoing application from MeDC@St system if it exceeds a 90 days stop-clock-time and any new applications which do not conform to requirements specified will be rejected, non-refundable.

• 2020-05-05 07:31:28

Registration of both local and foreign-manufactured medical devices in Malaysia is generally a two-part process. They are mainly regulated by the Medical Device Authority (MDA) of Malaysia, a local regulation and authorization body.

• 2020-05-05 07:53:33

HSA introduced evaluation routes to hasten the registration of high-risk devices. GN-15 contains the details of each routes. The latest update for GN-15 (version 7.2) improves the criteria for class B devices to undergo Immediate Class B Registration (IBR) Evaluation Route.

• 2020-05-05 06:46:09

NMPA releases the registration approval power to other NMPA branch to enhance the foreign medical device access to China market. This action brings more opportunities for the foreign manufacturers to get product license and enter China market.