UKRP Home Page - IMed UKRP
Working with IMed consultancy provides you with direct access to a permanent team of UK-based QA/RA experts that can guide you in entering the UK market. With experience supporting medical device and IVD manufacturers with their regulatory and compliance requirements globally, IMed Consultancy is ready to support your business here in the UK.
Regulating medical devices in the UK
2020年12月31日 · What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets. The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible...
UK Responsible Person (UKRP) for Medical Devices - Emergo by UL
Manufacturers with no local presence in the UK must now appoint a UK Responsible Person (UKRP). Your UKRP is responsible for managing your device registration as well as any relevant importer relationships, and liaising with the MHRA on your behalf.
UK Responsible Person: What Are the Requirements?
2022年11月10日 · The UKRP is the UK equivalent of the EU Authorised Representative for EU MDR and IVDR; this is no longer applicable within the UK. The UKRP is responsible for the following activities: Managing your device registrations with the Medicines & Healthcare Regulatory Agency (MHRA).
UK Responsible Person (UKRP) - QAEC Limited
QAEC Limited provides specialised UK Responsible Person (UKRP) services to ensure your compliance with UK MDR 2002. As experts, we are dedicated to helping manufacturers navigate the regulatory landscape for medical devices in the UK.
UK Responsible Person Services for Medical Device Manufacturers
Freyr provides UK Responsible Person (UKRP) services to foreign medical device manufacturers for product registration and market entry in the UK.
UK Responsible Person (UKRP) for Medical Devices & IVD - QbD …
Are you a medical device and/or IVD manufacturer based outside the UK, but selling in the UK? If so, you need a UK Responsible Person (UKRP). Qarad UK Ltd. – part of the QbD Group – is an independent partner that can act as your UK Responsible Person (UKRP).
UKRP是什么？医疗器械投放英国必须有英代吗？ - 搜狐
2023年10月7日 · 根据英国 mdr 2002（2019 年修订），ukrp 的定义如下： “在英国设立的人员，代表在英国境外设立的制造商执行与制造商在这些法规下的义务相关的特定任务。
如何选择医疗器械的英国UKCA的UKRP英代？ - 知乎专栏
2021年7月27日 · UKRP的可靠性主要考察两个方面：一个是在英国本土运营人员的专业水准，另一个是产品上市后监督体系中UKRP扮演的角色以及配合的及时性和专业度。 无疑，SUNGO在这两个方面都有绝对优势，才能成为以UKRP角色为国内厂家完成器械注册最多的机构。 距离2020年12月31日英国正式脱欧，目前英国脱欧大半年，中国医疗器械厂商是否已经重新办理属于英国的UKCA，选择了合规的英代UKRP,重新办理了英国MHRA注册呢？ 从英国医疗器械MHRA注册 …
英国 UKRP - MedNet
该法规要求非英国境内的IVD制造商必须任命一个英国代表人（UK RP），作为英国当局跟制造商的联系窗口。 我们MedNet EC-REP了解英国所有现行法规和过渡规则，将为您在英国MHRA数据库中完成产品注册，以支持您的产品快速进入市场。 在英格兰、苏格兰和威尔士销售化妆品时，产品必须符合英国当地的化妆品法规。 该法规规定，非英国制造商必须指定一个位于英国的代表人，在英国化妆品安全与标准办公室（OPSS）注册其代表的产品。 MedNet作为您的英国代表 …