Three certifications come up in almost every conversation about importing laboratory equipment: CE (European Conformity), FDA registration (US), and ISO 13485 (medical device quality management).
## CE Marking
Mandatory for equipment sold in the European Economic Area. The relevant directives for laboratory equipment are the Low Voltage Directive, EMC Directive, and (for medical devices) the Medical Device Regulation (MDR 2017/745).
## FDA Registration
Required for medical devices marketed in the United States. Most general laboratory equipment (e.g. centrifuges, microscopes) does not require 510(k) clearance, but the manufacturer must still register their establishment and list the device.
## ISO 13485
International standard for quality management systems of medical device manufacturers. Required by many hospitals and procurement tenders even when not mandated by law.