• 2020-06-16 07:38:56

In China, AI medical devices are evolving, and its regulatory system is also being developed rapidly. We have researched applications of AI to medical device and clinical assistance in China, as well as, outstanding Chinese AI companies and related AI products.

• 2020-05-12 07:03:38

We discuss the different types of cosmetic implants and the key drivers to their ever-increasing market growth. We focused on the fastest growing market share, ASEAN, and the top players in the different types of implants.

• 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.

• 2020-03-18 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.

• 2020-02-21 07:14:51

Health spending is growing faster than the overall economy globally as well as in most countries. In this article, we are looking at the healthcare expenditure and medical device demand trends in China, Thailand, Malaysia and Singapore, to understand how their government are spending to improve the living standard of their citizens.

• 2020-02-21 06:52:42

Recently on November 13, NMPA had issued a notice on the suspension and rectification of a domestic manufacturing factory,, instructing the manufacturer to stop production until rectification is completed and approved by NMPA. On the other hand, nearly 30 manufacturers (domestic and foreign) initiated voluntary recalls of their products in November. Similar news has been cropping up in recent year, and it’s foreseeable that NMPA will keep strengthening the surveillancein the future.

• 2019-12-18 09:21:23

In this issue, we have included China registration experience, along with some information on United States FDA and Europe’s requirement for high-risk cosmetic implants.

• 2020-05-06 07:05:38

The Medical Device Market of the Philippines offers Foreign Manufacturers a wealth of opportunities, due to the strong demand for innovative devices and the market’s extreme dependency on foreign imports. With local production covering less than 10% of the national demand and being restricted to a small variety of products, the Philippines promise favorable conditions for foreign companies interested in expanding to Asia.

• 2020-05-06 05:54:02

Qualtech is extending its service range and adds yet another country to its service list. Full assistance regarding Thailand medical device registration, local representation, and importation is now offered to our current and potential clients.

• 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.