If the product is cleaned in accordance with clause (a) or clause (b) above, the requirements content in clauses (a) and (b) of sub-paragraph 6.4 do not apply prior to the cleaning process. 7.5.1.2.2 Installation activities If appropriate, the manufacturer shall establish documented requirements which contain acceptance criteria for installing and verifying the installation of the medical device o ...

Recall Action Commencement Date: The date the recall strategy and communication was agreed by the TGA. vii Responsible Entity: Sponsor / Supplier / Importer responsible for the recall actions. viii Reason / Issue: Reason for the recall action. ix Recall Action: Recall action is an action taken to resolve a problem with a therapeutic good already supplied in the market for which there are issues o ...