Most manufacturers approach Asia as a single question — should we go? The markets inside it differ more from each other than Germany differs from Canada. Some are populated almost entirely by companies who were approved somewhere else first. Others are dominated by domestic manufacturers you have never heard of and cannot see from a Western desk. Which kind you are entering changes the strategy, the partner, and the price you can hold.
Request a demo →Rank the region's markets by how many of their manufacturers are registered only there and it splits cleanly into two kinds of market.
Importer markets — Hong Kong, Singapore, Malaysia — are populated overwhelmingly by companies who were approved elsewhere first. The competitive set is the one you already know from the US and Europe. Entry is a commercial problem: finding a partner who will actually push your product rather than shelve it beside forty others.
Domestic markets — China, Japan, and to a lesser extent India, Korea and Taiwan — are the opposite. In China the domestic field is overwhelmingly domestic — a large majority of registered manufacturers appear nowhere else. Those companies do not show up in a Western competitive analysis, they are frequently not operating in English, and they are often competing on a cost basis nobody modelled. A market-entry study that only counts the multinationals you recognise will understate the competition worst in exactly the markets where it is fiercest.
The practical read: importer markets are faster and cheaper to enter and defend a premium in. Domestic markets are larger and harder, and going in without knowing who is already there is how a launch quietly fails.
A useful amount of Asia-Pacific will shorten its own review because a trusted authority has already done one. The formal name is reliance, and the direction of travel across most of the region is toward more of it — IMDRF published a dedicated playbook for it in February 2026, and Malaysia and Singapore turned a cross-border reliance pilot into a standing two-way programme in March 2026.
That makes order a lever rather than a detail. Entering the reliance-friendly markets first means every subsequent filing starts from a stronger position, and the cost per market falls as you go. The markets that run a wholly independent assessment — China and Japan in particular — are their own projects and should be budgeted as such rather than tacked onto a regional plan.
One trap worth naming: reliance pathways key off your device's classification in the target market, not at home. Class is not portable, and a device that is Class II in the US can land higher elsewhere, at which point the shortcut you planned for may not be available. We published the divergence by device type because it is the single most common way a regional budget goes wrong.
The instinct is Singapore first — English-language, fast, no translation, and a regulator that lets a prior approval shorten the review. It is a reasonable first move and a poor whole strategy: it is also the smallest records base in the region, and the registration is held by your local dealer rather than by you.
Taiwan changes the order for you. Its route treats an existing approval as a prerequisite rather than a discount — something else has to be approved first, by design. So if Taiwan is anywhere on the list, the question is not whether to sequence but which approval you want to be holding when you get there. Thailand and Singapore both accept prior approvals as a shortcut; Japan and China accept none at all and review from scratch whatever you already hold.
The second axis is who ends up owning the registration. In Thailand your importer holds it. In Singapore, Taiwan and Japan a local representative holds it. That is a commercial decision disguised as a regulatory one: changing partner later can mean re-registering rather than reassigning, and it is far cheaper to negotiate before the filing than after.
Tell us your products and the markets you are weighing, and we will set up an account around your portfolio rather than give you a generic tour. Onboarding is free, and quarterly training and support come with every plan.
Most companies come to us with one of these four questions. Each one is a conversation, not a form.