Following Brexit, the UK authorities had announced in early 2021 that it planned to implement the OECD’s mandatory disclosure rules (MDR) under which intermediaries will have to report arrangements that may otherwise avoid international exchange of information under the OECD’s Common Reporting Standar...
5) 及时将投诉和事故信息传递给制造商;确认FSCA以及FSN及时提交给当局;配合当局实施预防措施和纠正措施。 需要办理以下认证可以随时找我 :出口欧盟:MDR CE认证/IVDRCE认证,欧盟授权代表,欧盟注册,欧盟自由销售证书 需要办理以下认证可以随时找我 :出口英国:英国代表,英国MHRA注册,UKCA认证,英国自由销售证书 需要办理以下...
HARROGATE, England: Neoss Group has recently announced that it has obtained certification under Regulation (EU) 2017/745 (Medical Device Regulation—MDR) ... share save NewsMon. 13 January 2025 Study reveals significant psychosocial challenges among dental administrative staff ...
Live Webinar | What’s Driving the Convergence Between EDR and MDR John Pelton • April 15, 2025 Compliance Live Webinar | AI vs. AI: Transforming Cybersecurity Through Proactive Technologies James McQuiggan • April 16, 2025 Compliance Anton Chuvakin Google Cloud Compliance Seth Vargo Google ...
De acordo com a Parte IV do Regulamento de Dispositivos Médicos, tal como se aplicam na Irlanda do Norte (SI 2002 NO 618, conforme emenda) (UK MDR 2002) até 25 de maio de 2022 Revisão da Documentação Técnica Dependendo da classificação dos dispositivos, revisamos a document...
Poland: The Polish Minister of Finance has published a General Interpretation regarding the legal professional privilege (LPP) of promoters and service providers in the context of the Mandatory Disclosure Rules (MDR). According to the General Interpretation, tax advisors and patent attorneys, due to ...
The UK MDR 2002 requires you to inform the MHRA before placing your device on the market in the United Kingdom. All non-UK businesses must designate a UK Responsible Person (UKRP) with a registered place of business in the UK to register with the MHRA. The following devices must be ...
去年9月,英国药监机构(MHRA)就现行的英国医疗器械法规2002(UK MDR 2002)发布了一项新的公共咨询,此公共咨询涉及英国脱欧后的医疗器械监管框架。对于大多数熟悉MDR 2002法规的人来说,此法规与欧盟的医疗器械指令(MDD 93/42/EEC)和体外诊断医疗器械指令(IVDD 98/79/EC)非常相似。因此,如果制造商想要进入英国市场,可...
Early 2022, several European national surveillance systems detected multidrug-resistant (MDR) bacteria related to Ukrainian patients.,Aim To investigate the genomic epidemiology of New Delhi metallo-β-lactamase (NDM)-producing Providencia stuartii from Ukrainian...
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