의료기기 이야기

1. Introduction Article 120 of the Medical Device Regulation (EU) 2017/745 (MDR), as amended by Regulation (EU) 2023/607, states that devices which are covered by valid certificates issued by a notified body under the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) or the Medical Devices Directive 93/42/EEC (MDD) may be placed on the market or put into service after the date of a..

The Hong Kong (HK) medical device regulatory systemMedical device makers who want to access the Hong Kong market must be aware of the latest regulatory requirements in this special administrative region of China. New developments in Hong Kong’s medical device market include additional leveraged country authorizations and a new digital platform.The HK Medical Device Division (MDD) and the Medic..

Background In addition to all the regulatory expertise shared and exchanged, as well as the networking, one of the benefits to RAPS Convergence conferences are the impromptu discussions. It was during one of these instances at RAPS Convergence 2023 (in the Exhibit Hall) that we were conversing with a notified body representative, who shall remain unidentified. This notified body representative p..

▶ MDCG 2020-3 문서가 'Regulation 2023/607'과 'MDCG 2022-2' 문서에 맞게 전체적으로 개정 되었음 ▶ Significant change - intended purpose - design - software - substance or materials - sterilization