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The Medical Devices Regulations 2002, Section 38A is up to date with all changes known to be in force on or before 03 October 2024. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations.
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38A.—(1) A person may make an application to the Secretary of State under this regulation for approval of a coronavirus test device.
(2) An application must include such information as the Secretary of State may require for the purposes of exercising their functions under—
(a)paragraph (5); and
(b)regulation 38C.
(3) An application must be made through the gov.uk website.
(4) The Secretary of State may treat an application made before the coming into force of this regulation as an application made under this regulation, if it meets the requirements of paragraph (2).
(5) The Secretary of State must approve a coronavirus test device if the Secretary of State is satisfied on the basis of the information contained in the application that the coronavirus test device meets the requirements of regulation 38B.
(6) An approval granted under paragraph (5) is valid for a period of 5 years, beginning with the day on which it is granted.
(7) Nothing in this regulation shall be taken to prevent—
(a)the Secretary of State;
(b)a weights and measures authority in Great Britain; or
(c)a district council in Northern Ireland,
from exercising a duty under regulation 61 to enforce these Regulations.]
Textual Amendments
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