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The Medical Devices Regulations 2002

The Medical Devices Regulations 2002 reg 56A

reg 56A Fees in connection with approval of coronavirus test devices

(1) A person who makes an application to the Secretary of State under regulation 38A(1) must pay to the Secretary of State a fee of— (a) £14,000; or (b) if the person is a small or medium-sized enterprise, £6,200. (2) Where the Secretary of State, in accordance with regulation 38A(4), treats an application made before the coming into force of regulation 38A as an application made under that regulation, a payment made in respect of that application before the coming into force of this regulation must be treated as— (a) a payment meeting the requirements of paragraph (1), if that payment would have met those requirements after their coming into force; or (b) a payment contributing in part to the payment required by paragraph (1), if that payment would not have met those requirements after their coming into force. (3) In this regulation— (a) a person is a small or medium-sized enterprise if it and persons associated with it employ no more than 250 individuals in total; and (b) “persons associated with it” has the same meaning as in section 882 of the Corporation Tax Act 2010.

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