MDSAP Audit Approach (MDSAP AU P0002) C2-T2: Hold the marketing clearance or approval each jurisdiction requires before commercial distribution (ANVISA registration or notification, Canadian licence, Japanese approval, FDA 510(k) or PMA)

What does C2-T2 require?

Management must obtain marketing authorization in each jurisdiction before commercial distribution and take it into account in design. Australia: the requirement sits with the sponsor and is not audited for the manufacturer. Brazil: registration (Classes III and IV, renewable after 10 years) or notification (Classes I and II) requested by the domestic manufacturer or importer. Canada: a medical device licence, or an amended licence after a section 34 change, before Class II to IV devices are imported or sold. Japan: marketing approval, certification or notification by the marketing authorization holder before marketing. United States: a premarket notification at least 90 days before introducing a device that is new to commercial distribution or new for the registrant (21 CFR 807.81), or premarket approval for Class III devices without a pre-1976 or reclassified predicate (21 CFR 814). Clauses: ISO 13485:2016 4.1.1, 4.2.1, 5.2, 7.2.1, 7.2.3.