Legislation – The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021
Amendment of the Medical Devices Regulations 20029.
“Fees in connection with approval of coronavirus test devices56A.
(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 20109.”.