MDSAP Chapter 2 — Device marketing authorization and facility registration

Chapter 2 is short and easy to skip. It asks whether the device is allowed on the market you sell into, and whether you tell the authority when the device or the quality system changes.

The product loads tasks 2.1, 2.2 and 2.3. They cover the submission and the facility registration, the evidence of clearance or approval, and notification of changes to the marketed device or to the QMS. Audit criteria in the product include current registrations, letters on file, and a regulatory impact check before you notify.

For a medical device company this is where the EU MDR and, if you sell in the participating MDSAP countries, those registrations meet the quality system. The checklist does not file the registration.

A change that starts as a CAPA or a document revision can be the change task 2.3 is looking for. HAVGATE links a CAPA to a document. It does not decide that a change is notifiable. Your procedure does, and the auditor reads that procedure.

The working checklist is the full 2.1 to 2.3 set inside /mdsap-audit-checklist and in the product, not a PDF. Grades, when you assign them, are explained on the grading page. Confirm the current audit approach document before you treat a task title as the only criterion.