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Introduction
Standards applied
20 / 60
LUCEA 50-100
IFU 01741 EN 11
Reference Year Title
Directive 2016/585/EU 2016 Exemption for lead, cadmium, hexavalent chromium and
PBDEs on medical devices
Directive 2017/2102 2017 Limitation of the use of certain hazardous substances in
electrical and electronic equipment
IEC 63000 2022 Technical documentation for the assessment of electrical
and electronic products with respect to the restriction of haz-
ardous substances
Regulation 1907/2006 2006 Registration, evaluation and authorization of chemical sub-
stances, as well as the restrictions applicable to these sub-
stances
US California Proposi-
tion 65 Act
1986 The Safe Drinking Water and Toxic Enforcement Act of 1986
Directive 2018/851 2018 Waste management
Directive 94/62/EC 1994 Packaging and Waste Management
SJ/T 11365-2006 2006 Administrative Measure on the Control of Pollution caused
by Electronic Information Products Chines RoHS (Restriction
of Hazardeous Substances)
Tab.6: Environmental standards and regulations
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 2022 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
Tab.7: Compliance with market standards
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