Número da Revisão
Rev.01
Data de Expiração
02/09/2027
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 X-Ray Equipment, Dental Software, Dental Equipmente for Prophylaxis, Dental Handpieces, Curing Lights, Dental Radiographic Image Scanner. Medical Ultrasound System and Small Steam Sterilizersm Intraoral Scanner”
Norma
ISO 13485:2016 Australia: Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3, Part 1 (excluding Part 1.6) - Full Quality Assurance System Brazil: RDC ANVISA nº 665/2022 RDC ANVISA nº 551/2021 RDC ANVISA nº 67/2009Canada: Medical Devices Regulations – Part 1- SOR 98/282 Medical Devices Regulations – Part 1.1 – SOR 98/282 (as applicable) 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