• 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 08:57:04

NMPA has revised the quality inspection measure of medical devices to show their determination on strengthening post-market surveillance. The worst-case scenario manufacturers may face in PMS would be total product recall.

• 2020-04-14 08:54:35

Guiding manufacturers to develop medical devices which are safe and high performing, NMPA has released basic principles of investigation for all class of medical devices.

• 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 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 03:44:26

The Health Sciences Authority (HSA) of Singapore has published an updated GN – 21 R4.6: Guidance on Change Notification last February 2020, effectively renaming it to GN – 21 R4.7.

• 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.

• 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.

• 2020-04-14 01:28:54

The Medical Device Division will continue the trial to study the feasibility for Local Responsible Persons (LRP) to prove their medical device conform the “Essential Principles of Safety and Performance of Medical Devices” .