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, 88% of registered manufacturers appear in no other market we cover. 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 ran a cross-border reliance pilot through to that same month.
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.
"Registered only here" is the share of a market's manufacturers who appear in none of the other 29 markets we cover — the closest single measure of how much of your competition is local. "Also holds US or EU" is the share who were approved in a major market too.
| Market | Product records | Manufacturers | Registered only here | Also holds US or EU |
|---|---|---|---|---|
| India | 181,810 | 9,314 | 61.2% | 30.4% |
| Japan | 99,817 | 3,763 | 78.0% | 12.1% |
| South Korea | 93,873 | 13,747 | 53.9% | 30.8% |
| Taiwan | 93,061 | 19,077 | 54.0% | 31.2% |
| China | 86,075 | 19,585 | 88.0% | 9.7% |
| Indonesia | 83,981 | 8,558 | 29.2% | 52.5% |
| Thailand | 82,300 | 12,961 | 32.7% | 46.6% |
| Australia | 64,133 | 9,923 | 24.5% | 63.7% |
| Vietnam | 54,032 | 7,134 | 30.8% | 57.0% |
| Malaysia | 41,791 | 4,104 | 20.4% | 63.1% |
| Philippines | 30,911 | 4,606 | 71.5% | 22.6% |
| Singapore | 21,717 | 3,282 | 9.3% | 80.7% |
| Hong Kong | 14,323 | 2,008 | 4.4% | 86.9% |
Figures from the Meridian Trace corpus, August 2026. Record counts are not market size — markets catalogue at different levels of detail, and a bigger number often means a more granular filing convention rather than a bigger opportunity. Company identity is resolved across scripts and spelling variants, which is a derived judgement rather than a registry fact.
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.