Practical guides on medical device registration across Asia. Registry explainers, market entry research, competitive intelligence. Published every Monday.
The local importer requirement, class A–D timelines, what goes wrong most often, and how to check current registration status.
GDA vs. full registration, the reference pathway for FDA/CE holders, what MEDLINE shows and what it doesn't.
The shonin/ninsho distinction, the MAH requirement, realistic timelines, and how to use PMDA's public database.
MFDS classification, the Korean regulatory agent requirement, how the public MFDS database works.
Thailand's A/B/C/D system and how it maps (or doesn't) to other classification frameworks. Common documentation traps.
What the registration data across 585,000+ records actually shows — by market and category.
180,000+ records. Here's what's actually in them — by class, category, manufacturer, and status.
Ranked by number of markets with active registrations, not just revenue. The results are interesting.
A practical step-by-step workflow. The question you should ask before "how do we register" is "who's already registered."
Regulatory due diligence before the contract. Distribution agreements in this region are hard to exit — do this first.
The specific failure modes, and when the manual approach stops working. Honest take.
Government fees are the smallest part. Here's the full picture across Indonesia, Singapore, Malaysia, and Thailand.
A lapsed registration doesn't mean immediate distribution shutdown. But it does create a problem you need to act on.
The standard advice is "start with Singapore." That's not always wrong — but it's not always right either. A decision framework.
585,000+ medical device registrations across 8 Asian markets. Free to start.