• 2020-06-16 08:03:29

NMPA released the Draft Revision of Guidance of Software for Medical Device Registration, which increased the scope of application, while paying more attention to the review of technical documents.

• 0000-00-00 00:00:00

Despite the effect of COVID-19 outbreak, ThaiFDA continued to perform at its best for the Medical device regulation reform update. Future regulation follows Risk- based Classification, while current regulation follows Policy- based Classification. Thai FDA Announced that Manufacturer and Importer must Proceed Medical Device to be Licensed Registration.

• 2020-05-12 08:17:52

Future regulation follows Risk- based Classification, while current regulation follows Policy- based Classification. Ministry of Public Health Announcement regarding the Definition of Medical Device that Manufacturer and Importer must Proceed Medical Device to be Licensed Registration 2020, in order to gradually promote the transition of Thailand future regulation implementation.

• 2020-05-12 06:28:19

Although Thailand has decreased the numbers of infections significantly yet to relieve since the disease is very contagious. Food and Drug Administration is decidedly in concern that Thailand shall have enough resources in hands to dispute this COVID-19 Outbreak via the Fast Track option developed by ThaiFDA for manufacturer and importer of COVID-19 related products.

• 2020-05-12 06:08:27

NMPA of China released the registration work report in April 2020, covering the milestones of medical device regulations and registration applications from last year. In addition to actively improving relevant regulatory regulations and standards, NMPA also gradually adjusts its internal operating methods.

• 2020-04-14 08:47:59

In order to promote high-quality medical device industry, China is looking for ways to encourage domestic manufacturers to adopt higher technology and introduce incentives for foreign manufacturers with investments by local establishments.

• 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.