Document ID: chunk:federal_register_of_legislation:F2024L01673:clause:1_4
Version: federal_register_of_legislation:F2024L01673
Segment Type: clause
Provision Reference: sch 1 cl 4
Character Range: 4200–6308

4  Part 2 of Schedule 4 (table item 2.17, column headed "Conditions", paragraphs (c) to (e))
Repeal the paragraphs, substitute:
(c) The sponsor holds information or evidence to support:
(i) the statement made in the sponsor notice under subparagraph (b)(i) of the column headed "Kinds of medical devices" of this item; and
(ii) if the sponsor has not given a notice under paragraph (e) of this column of this item—the statement made in the sponsor notice under subparagraph (b)(ii) of the column headed "Kinds of medical devices" of this item; and
(iii) if the sponsor has given one or more notices under paragraph (e) of this column of this item—the statement made in the most recent of those notices;
 including, in relation to a statement that the device complies with the essential principles, to demonstrate ongoing compliance with the essential principles.
(d) The following statements are, and continue to be, correct:
(i) the statement made in the sponsor notice under subparagraph (b)(i) of the column headed "Kinds of medical devices" of this item;
(ii) if the sponsor has not given a notice under paragraph (e) of this column of this item—the statement made in the sponsor notice under subparagraph (b)(ii) of the column headed "Kinds of medical devices" of this item;
(iii) if the sponsor has given one or more notices under paragraph (e) of this column of this item—the statement made in the most recent of those notices;
 including, in relation to a statement that the device complies with the essential principles, that the device continues to comply with the essential principles.
(e) The sponsor must:
(i) if requested by the Secretary, give the Secretary a notice, in a form approved in writing by the Secretary, stating either that the device complies with the essential principles or that the device is being imported or supplied (as the case may be) with the consent of the Secretary under section 41MA or 41MAA of the Act; and
(ii) do so within the period requested by the Secretary (which must be at least 5 working days starting on the day on which the Secretary's request is made).