Global medical device regulatory updates and registration guides
On 20 May 2026 the Singapore Health Sciences Authority (HSA) held an online industry briefing on medical devices, and published
As ASEAN’s trade hub and a preferred location for regional headquarters, Singapore is becoming the first overseas stop for more
From 28 May 2026, some core modules of the EU EUDAMED system became mandatory. The one manufacturers care about most
Some time ago, a client consulted us about a medical device with metal parts that was already on sale in
If you are considering selling medical devices in Southeast Asia, Malaysia is almost unavoidable as the first stop. The country
They determine what kind of tank every liter of fuel you buy today comes out of. 1. It Started with
As global trade deepens, more and more Chinese companies want to export instruments and measuring equipment to the EU. Technical
South Korea is one of the world’s major medical device markets, with a mature and continuously updated regulatory system. Since
Japan is the world’s second-largest medical device market and an important target for Chinese medical device companies going global. Its
1. The Five Compliance Requirements at a Glance Although veterinary X-ray machines are not subject to FDA 510(k) requirements for
