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Medical & dental supplies

Disposables and instruments are regulated differently by country. Treat regulatory path as part of the RFQ.

Compliance checklist

  • FDA 510(k) / registration context for US (device class dependent)
  • MDR / MDD pathways for EU
  • Sterility and bioburden claims must match validated process
  • UDI / labeling for regulated markets

Spec template (copy into RFQ)

Device / SKU name:
Intended use & risk class (buyer to state):
Sterile vs non-sterile:
Materials & single-use vs reusable:
Shelf life & storage:
Lot traceability (UDI if required):
Packaging & language on label:
MOQ & lead time:
Destination market regulatory owner (buyer vs supplier):
Open sourcing briefLanded cost tool

Red flags

  • CE mark on non-EU pathway without technical file discussion
  • “Hospital grade” without standard reference
  • Refusal to provide batch COA or sterilization validation summary

Questions before deposit

  • Who is legal manufacturer vs distributor on label?
  • What notified body or QMS certificates apply?
  • What happens if port rejects shipment for paperwork?