Rehabilitation equipment for Japanese and Korean importers
Japan and Korea both require a locally licensed entity to hold the product registration, and both look closely at documentation quality in Japanese or Korean β an English-only IFU will usually be rejected by the distributor before it ever reaches the authority.
The two systems work differently, so they are described separately below.
How these products are classified
Japan: under the Pharmaceuticals and Medical Devices Act (PMDA), most walking aids and bath safety products are Class I general medical devices, filed by notification (todoke) through a Marketing Authorization Holder (MAH) established in Japan. Korea: under the Medical Devices Act, Class I devices are notified to MFDS, and the importer must hold an importing licence and act as the licence holder.
This is general guidance based on how these product types are normally regulated. Final classification for your exact product and claims is decided by your regulatory advisor or the authority.
Documents required, and who files each one
Most first-order delays come from a document nobody realised was the importerβs responsibility. This is the split.
| Document | Responsibility | Notes |
|---|---|---|
| Japan: MAH appointment | You / your local entity | A Japan-based MAH is mandatory. Without one, no notification can be filed. |
| Japan: Class I notification (todoke) | You / your local entity | Filed by the MAH with PMDA; we supply the technical file it is based on. |
| Japan: IFU and labelling in Japanese | Shared | Japanese IFU, SE (single use) and manufacturer/MAH blocks are mandatory. We set the layout; your MAH approves the wording. |
| Korea: importing licence + licence holder | You / your local entity | The Korean licence holder files the Class I notification with MFDS. |
| Korea: Korean-language labelling | Shared | Korean IFU and label with the licence holderβs details and the MFDS notification number. |
| ISO 13485 + test reports | We provide | Both markets accept ISO 13485 as the quality evidence; load and stability test reports support the filing. |
How the goods get there
What usually goes wrong
- Shipping before an MAH or Korean licence holder exists β the goods cannot be cleared for medical use.
- Reusing an English IFU with a Japanese sticker added; both authorities expect the full translated text.
- Assuming Japanese buyers accept CE marking as evidence β they do not; the domestic filing is what counts.
Categories that move in this market
Japan & Korea buyer questions
Can you register the product in Japan for us?
Do you already supply Japanese or Korean distributors?
Which incoterm works best for small first orders?
Other markets
Shipping to Japan & Korea?
Send the product and destination. We reply in 24 hours with the document list for your market, the responsible party for each item, and an itemised FOB quote.