The organisation must meet each jurisdiction's facility registration, licensing and device listing rules where it markets devices, and its labelling should show who the legal manufacturer is. Australia: the sponsor applies for ARTG inclusion using the manufacturer's evidence (such as an MDSAP certificate); the manufacturer must have a documented way of preparing and keeping up to date a signed Declaration of Conformity for devices on the ARTG (Sch 3 Pt 1 cl 1.7, Pt 4 cl 4.7 or Pt 6 cl 6.6). Brazil: a domestic manufacturer needs ANVISA's company operating authorisation (AFE); marketed devices must be registered (Classes III and IV, valid 10 years) or notified (Classes I and II) through a domestic manufacturer or importer, with GMP certification a prerequisite for registration. Canada: no Class II to IV device may be imported or sold without the manufacturer's medical device licence, and applications include an ISO 13485 QMS certificate (CMDR 26 and 32). Japan: a Japan-resident marketing authorization holder files approval, certification or notification applications, and sites doing main design, main assembly, sterilisation or domestic final-release storage must be Registered Manufacturing Sites. United States: owners or operators of establishments that manufacture, develop specifications, repackage, relabel, sterilise, import, hold complaint files or make ready-to-use components must register and list devices under 21 CFR 807. Clauses: ISO 13485:2016 4.1.1, 4.2.1, 5.2, 7.2.1, 7.2.3.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.