• 2020-05-12 08:21:54

Ventilators are recently allowed to be imported into the country under special access route, in light of THE COVID-19 emergency. Now, MDA has specified requirements to be followed for this special situation, to mitigate the risks that may follow.

• 2020-05-12 08:06:46

In order to tackle the threat of COVID-19, PMDA takes some measures to speed up the development of medical products for COVID-19. Now, timeline for clinical trials are shortened and IRB meeting are allowed to be held in unconventional ways.

• 2020-05-12 07:39:23

Health Sciences Authority (HSA) ensure the availability of respiratory devices for COVID – 19 patients. HSA placed flexible regulations such as allowing the use of emergency ventilators, clarifying the applicable change notification category that will not require approval and demonstrating the means for adding new model of respiratory devices.

• 2020-05-12 07:00:43

Health Sciences Authority (HSA) ensures the availability of test kits for the detection and diagnosis of COVID – 19. For these devices, a provisional authorization process is implemented, which can be done via email and be responded by HSA within three (3) working days.

• 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.

• 2020-04-14 12:02:03

Local health authorities in Asia Allow certain products to be exempted from the regular registration routes and, in some cases, even being eligible to be imported directly.

• 2020-04-14 08:36:06

Malaysia makes efforts to keep the Covid-19 outbreak contained in the country. Medical Device Authority issued a few more important advisories.

• 2020-04-14 05:08:33

PFDA implemented FDA Circular No. 2020-001 last March 13, 2020. However, PH government enforced enhanced community quarantine due to COVID-19 pandemic last March 17, prompting PFDA to release several issuances regarding guidelines on PFDA transactions during the quarantine period.

• 2020-04-14 02:41:07

Qualtech will update you on the new expedite registration channels in China, Singapore, Malaysia, and Indonesia in the context of the COVID-19. While also introducing the existing regular fast tracks for urgently needed medical devices.