Manufacturing for your market, not for a generic one
The product is the same; the paperwork is not. A shower chair shipped to Rotterdam needs a Declaration of Conformity and an EUDAMED entry, the same chair shipped to Jebel Ali needs Arabic labelling and an attested certificate set. Choose your market below and see exactly what is required, who files it, and how the goods get there.
North America
FDA establishment registration, Class I device listing and 21 CFR 801 labelling for walking aids, shower chairs and commode chairs shipped to the US and Canada.
Europe (EU)
CE marking, EU Declaration of Conformity, EUDAMED and technical documentation for Class I rehabilitation equipment imported into the European Union.
United Kingdom
MHRA device registration, UKCA marking and the current status of CE recognition for rehabilitation equipment supplied to Great Britain.
Japan & Korea
PMD Act notification in Japan and MFDS import licensing in Korea for walking aids, walkers, shower chairs and commode chairs.
Middle East
SFDA registration in Saudi Arabia, MOHAP registration in the UAE, and the documentation package required for GCC medical device tenders.
What is the same in every market
- Production in 15–30 days after order confirmation — identical regardless of destination.
- MOQ from 30 units per SKU on selected models; the market does not change the minimum.
- Batch inspection report and Declaration of Conformity with every shipment.
- Label artwork built for your market before production, not applied afterwards.
Tell us the destination, get the document list
Send the country and the product category. We reply with the documents your customs broker and regulator will ask for, and who has to file each one.