Número da Revisão
Rev.01
Data de Expiração
03/09/2027
Descrição
Scope: "Design, Manufacture, Distribution, Sales, Installation and Service of Machine Raw Material for Medical Devices Industry Scope Particularity: Dental Chairs, Dental Delivery Units, Dental Light, Dental Water Units, Vaccum Pumps, Compressors, Dental Scanner” Not applicable items: 7.5.5 – Particular Requirements for Sterile Medical Devices 7.5.9.2 – Particular Requirements for Implantable Medical Devices
Norma
ISO 13485:2016 Australia: Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3, Part 1 – Full Quality Assurance System Brazil: RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021; RDC ANVISA nº67/2009 Canada: Medical Devices Regulations – Part 1- SOR 98/282 Japan: MHLW Ministerial Ordinance No.169 (2004), as amended by MHLW Ministerial Ordinance No.60 (2021) USA: 21 CFR Part 803 – Medical Device Reporting 21 CFR Part 806 – Reports of Corrections and Removals 21 CFR Part 807 (Subparts A to D) – Establishment Registration and Device Listing 21 CFR Part 820 – Quality System Regulation
Status
Ativo