Brazil: changes to ANVISA-approved devices classed as significant (affecting safety and effectiveness features, device or manufacturer identity or site, indication, classification, technical specification or manufacturing method, for example sterilisation method, materials, new manufacturer, labels and instructions, software version or new accessories) must be submitted for new approval (Law 6360/76 Art 13). Canada: significant changes need a licence amendment application (CMDR 34); licence holders must send an annual signed statement of other changes before 1 November (CMDR 43), tell the Minister within 30 days of discontinuing sale (43(3)) and send any new or modified QMS certificate within 30 days of issue (43.1). Japan: changes to approved or certified devices may need a new application, change application or change notification by the marketing authorization holder, and a Registered Manufacturing Site must tell the holder in advance of planned changes (MO169 Art 29). Clauses: ISO 13485:2016 7.2.3, 7.3.9.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.