MDSAP (ISO 13485:2016)

Australia: Therapeutic Goods (Medical Devices) Regulations 2002, Schedule 3, Part 1-Full Quality Assurance System

Brazil: RDC ANVISA n. 665/2022- Good Manufacturing Practices; RDC ANVISA n. 551/2021–Field Actions; RDC ANVISA n. 67/2009- Vigilance

Canada: Medical Devices Regulations (SOR/98-282) Part 1-General

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 Management System Regulation

ISO 13485:2016/EN ISO 13485:2016

Medical devices - Quality management systems - Requirements for regulatory purposes

Medotex Biotech (HangZhou) Co., Ltd.

Our manufacturer has provided with all the appropriate declaration according the Directive 98/79/EC requirements including the EC Declaration of Conformity confirming that the in vitro diagnostic medical devices