• 2020-05-12 06:20:32

On 2011, China NMPA published the 1st edition of “Guidance of Adverse Event Monitoring for Medical Device”. Now, they make a dramatic change on the adverse event system and modify the guidance according.

• 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 08:57:04

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 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.

• 2020-03-18 08:59:24

The halal market is promised with billion opportunities. In this article, we will guide you through the market potential of halal products in Indonesia and Malaysia as well as regulatory standard of halal medical device, to give you insights of how to seize the chance to expand your business.

• 2020-03-16 07:02:46

ThaiFDA has decisively made an announcement by Ministry of Public Health Announcement regarding Cleaning Products Containing Alcohol as a Component for Hygienic Use 2019 and Ministry of Public Health Announcement regarding Cleaning Products Containing Alcohol as a Component for Hygienic Use 2019.

• 2020-03-16 06:50:01

Medical Devices (Amendment) Rules, 2020 has been newly issued to amend the Medical Devices Rules, 2017. Medical Devices (Amendment) Rules, 2020 will be effective 1st April 2020. All medical devices in India is now to be regulated as “drugs”.