{
  "url": "https://openlegislation.uk/draft-medical-devices-coronavirus-test-device-approvals-amendment-regulations-2021/regulation-9",
  "json_url": "https://openlegislation.uk/draft-medical-devices-coronavirus-test-device-approvals-amendment-regulations-2021/regulation-9.json",
  "legislation": "ukdsi/2021/9780348224795",
  "legislation_title": "The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021",
  "legislation_url": "https://openlegislation.uk/draft-medical-devices-coronavirus-test-device-approvals-amendment-regulations-2021",
  "path": "regulation/9",
  "kind": "regulation",
  "number": "9",
  "heading": "Amendment of the Medical Devices Regulations 2002",
  "text": "After regulation 56 (fees payable in relation to clinical investigation bodies) insert—\n“Fees in connection with approval of coronavirus test devices\n56A. (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—\n(a) £14,000; or\n(b) if the person is a small or medium-sized enterprise, £6,200.\n(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—\n(a) a payment meeting the requirements of paragraph (1), if that payment would have met those requirements after their coming into force; or\n(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.\n(3) In this regulation—\n(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\n(b) “persons associated with it” has the same meaning as in section 882 of the Corporation Tax Act 2010.”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "2010 c. 4."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukdsi/2021/9780348224795/regulation/9",
    "retrieved_at": "2026-10-30T14:46:56.445827+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}