Machined medical components leave southern Vietnam by air from Tan Son Nhat or by sea from the Cat Lai and Cai Mep terminals, both now inside Ho Chi Minh City. Each destination adds its own regulatory frame for the device maker, its own trade agreement for origin and duty and its own habits on documents and packaging. As of October 2026 the lanes below are the ones buyers ask about most. Every duty and origin point is a check to run with your customs broker, not a rate we promise.
| Destination | Regulatory frame (device maker’s duty) | Trade agreement to check | Duty point to confirm | Typical air / sea time | Packaging habit |
|---|---|---|---|---|---|
| United States | FDA, QMSR (21 CFR 820); component makers exempt from registration under 807.65(a) | None in force with Vietnam | HTS base rate plus Section 301 12.5% from 24 July 2026 unless exempt; Section 232 metals | 5 to 10 days / 25 to 45 days | Bagged per lot, carton labels matching the PO |
| European Union | MDR (EU) 2017/745; supplier controls and possible notified body audits | EVFTA | TARIC rate; preference with proof of origin | 5 to 10 days / 30 to 50 days | Lot labels, substance declarations on request |
| Japan | PMD Act, PMDA | VJEPA, CPTPP, RCEP, AJCEP | Preferential rate with the matching certificate | 3 to 6 days / 10 to 18 days | Detailed inspection records, strict cosmetic standards |
| South Korea | MFDS | VKFTA, RCEP, AKFTA | Preferential rate with the matching certificate | 3 to 6 days / 7 to 14 days | Inspection records in English, Korean labels if asked |
| Singapore | HSA | ATIGA, CPTPP, RCEP | Most goods duty-free; GST on import | 2 to 4 days / 3 to 7 days | Regional plant receiving specifications |
| Australia | TGA | AANZFTA, CPTPP, RCEP | Preferential rate with origin proof | 4 to 8 days / 14 to 25 days | Biosecurity rules for wooden packaging |
Typical values. Transit times are door to door for air and port to port or door to door for sea depending on the service; confirm with the forwarder. Agreement names are listed so you know what to ask about; eligibility depends on the rules of origin for your tariff code.
What every lane has in common
- The shop is a supplier. On every lane the device maker carries the regulatory duties for the device. The component shop works under the maker’s purchasing controls and supplies records.
- Origin is documented, not declared. Keep the bar or plate mill certificate, the traveller and the packing list consistent. They are the evidence behind any origin claim.
- The Incoterm decides who clears. EXW, FCA or FOB Ho Chi Minh City puts import clearance and duty on the buyer. DDP moves it to the seller and needs a duty clause.
- Wooden packaging usually needs ISPM 15 treatment and marking; check the destination’s rule. Most machined part shipments use cartons and plastic pallets to avoid the question.
Lane pages
The detail pages go through each gate in order: the shop’s regulatory position, the device maker’s supplier controls, export from Vietnam, entry and duty and incoming inspection.
| Lane | Status |
|---|---|
| United States | FDA position of a component shop, QMSR flow-down, duty layers as of October 2026 |
| European Union | MDR supplier audits, EVFTA proof of origin, REACH and RoHS data |
| Japan, South Korea, Singapore, Australia | Planned |
For the paperwork by stage, see the customs documents checklist and the landed cost worksheet. For the shop side of quality records, see quality and documentation.
This hub is a planning overview, not legal, customs or regulatory advice. Send your drawing through the RFQ form with the destination and Incoterm, and we reply within 24 business hours.