In How Many Countries Is a Filler Approved? A Practical Cross-Border Regulatory Comparison (NMPA/FDA/CE/PMDA/MFDS)
Using mainstream hyaluronic acid fillers as an example, we walk through the differences between China's NMPA, the US FDA, EU CE/MDR, Japan's PMDA and Korea's MFDS — and how to quickly verify a product's global approval status.
"Is this product approved overseas?" is one of the most common questions in medical aesthetics — procurement, competitive analysis and patient communication all depend on it. But the five major registration systems differ substantially, and conclusions rarely transfer across borders.
The five systems at a glance
| System | Authority | Filler classification | Public lookup |
|---|---|---|---|
| China NMPA | National Medical Products Administration | Class III device | Official database |
| US FDA | Food & Drug Administration | Class III, PMA approval | PMA/510(k) databases |
| EU CE (MDR) | Notified bodies + EUDAMED | Class III under MDR 2017/745 | EUDAMED (partial) |
| Japan PMDA | Pharmaceuticals & Medical Devices Agency | Highly-controlled device | PMDA search |
| Korea MFDS | Ministry of Food and Drug Safety | Grade 4 device | MFDS portal |
Three common misconceptions
"FDA approval = global endorsement." FDA PMA and NMPA registration are independent reviews; indications, injection planes and labeling can all differ.
"CE mark = official EU approval." CE is a conformity declaration plus notified-body certification; during the MDR transition, old and new certificates coexist.
"Same brand = same product." The same brand often ships different models/concentrations/cross-linking in different markets — approval status must be verified per model.
How to verify quickly
- Get the exact trade name and model (Chinese marketing nicknames abound);
- Query each registry — the time sink, five systems with five interfaces;
- Align indications and approval dates, and watch certificate expiry.
Inside Medcxy this collapses into a single question: product Q&A is wired to NMPA + EUDAMED + PMDA + MFDS data and answers "where is X approved" with a comparison table of registration numbers and dates per system — every claim traceable to the registry source.
Registration data changes with regulatory updates; for major decisions rely on the latest official publications.
Medcxy: sentence-level compliance review · cross-border regulatory comparison · vertical knowledge Q&A.
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