Introduction
Information relating to intended use
1
Maquet PowerLED II
IFU 01811 EN 10
31 / 116
Country Reference Year Title
Argentina Dispocision
2318/2002
2002 Administración Nacional de Medicamentos, Ali-
mentos y Tecnología Médica - Registro de pro-
ductos Medicas - Reglamento
Australia TGA 236-2002 2019 Therapeutic Goods (Medical Devices) Regula-
tions 2002. Statutory Rules No. 236, 2002 made
under the Therapeutic Goods Act 1989
Brazil RDC 665/2022 2022 GMP Requirements for Medical Devices and IVDs
Brazil RDC 185/2001 2001 Technical regulation about the registration of
medical products at ANVISA, as well as its altera-
tion, revalidation, or cancellation
Canada SOR/98-282 2021 Medical Devices Regulations
China Regulation 739 2021 Regulation for the Supervision and Administration
of Medical Devices
EU Regulation
2017/745/EU
2017 Medical Devices Regulations
Japan MHLW Ordin-
ance: MO No.
169
2021 Ministerial Ordinance on Standards for Manufac-
turing Control and Quality Control for Medical
Devices and In-Vitro Diagnostics
South Korea Act 14330 2016 Medical Device Act
South Korea Decree 27209 2016 Enforcement Decree of Medical Act
South Korea Rule 1354 2017 Enforcement Rule of the Medical Act
Switzerland RS (Odim)
812.213
2020 Medical Devices Ordinance (MedDO) of 1 July
2020
Taiwan TPAA
2018-01-31
2018 Taiwanese Pharmaceutical Affairs Act
UK Act 2021 Medical Devices Regulations 2002 No.618
USA 21CFR Part 7 2017 Title 21--Food And Drugs
Chapter I--Food and Drug Administration Depart-
ment of Health and Human Services
Subchapter A -- General
PART 7 - Enforcement policy
USA 21CFR
Subchapter H
- Title 21--Food And Drugs
Chapter I--Food and Drug Administration Depart-
ment of Health and Human Services
Subchapter H -- Medical Devices
Tab.7: Compliance with market standards
1.9 Information relating to intended use
1.9.1 Intended use
The Maquet PowerLEDII range is designed to illuminate the body of a patient during surgical op-
erations, diagnostics or treatment.
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