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CE Rep & CE Marking
Before the medical device can be marketed and supplied in the European market, the manufacturer must appoint an EC Representative for manufacturers not based in Europe. The product must be affixed with the EC Rep and the CE marking by undergoing conformity assessment to demonstrate the device has met the essential requirements defined in the applicable requirements in:
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European Medical Device Regulation (MDR 2017/745), with 3 years transition and extended until effective on 26 May 2021
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In-vitro Diagnostic Medical Device Regulation (IVDR 2017/746), with 5 years transition until effective on 26 May 2022
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EU MDD/AIMDD/IVDD directives
UK Rep & UKRA Marking
From 01 Jan 2021, companies need to register their product with MHRA to gain market entry in UK. UK Rep, UKCA marking, Labelling and Product registration are required. There are different grace period for different risk classification of the product and different country/region in Great Britain (GB), Northern Ireland (NI) and European Union (EU).
For UK Rep or UK responsible person, it has to be appointed by manufacturers that are not based in UK.
For UKCA marking, companies assessed the conformity via UK-appointed Approved body such as BSI to obtain UKCA (0086).
Below table summarizes highlights various requirements and timeline for GB, NI and EU in order to comply with the transition on UKCA marking Post Brexit.
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EU MDD/AIMDD/IVDD directives
Source: Webinar on UKCA Marking – EEN
(The webinar was jointly organized by Singapore Manufacturing Federation and Enterprise Europe Network. Supported by Enterprise Singapore & BSI.)
Key Q&A:
Q1. What are the product marking that can be used in the UK?
Ans:
A product with both UKCA and CE will be able market in GB, NI and EU.
A product with only CE will still be able to market in NI and EU, however CE will be allowed until 30 Jun 2023 in GB.
A product with only UKCA can be used from 01 Jan 2021 in GB and it is mandatory from 01 Jul 2023. In NI and EU, UKCA marking alone is not accepted.
Q2. What are the transitions expected on labelling for Post Brexit non-UK and UK manufacturers?
Q3. What are the product registration requirement for UK market?
Q4. How is the transition taking place in the GB market after 01 Jan 2021?
Swiss Rep
据瑞士医疗科技网站Swiss MedTech报道，瑞士正在制定一项国家医疗器械条例（MepV）。由于与欧盟的谈判很可能失败，瑞士此举意在退出欧盟体系。受此影响，瑞士境外的医疗器械制造商只有在拥有瑞士代表处的情况下，才能在瑞士销售其医疗器械。
本文讨论的过渡时期包括：
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2021年12月：III类、IIb类植入式医疗器械、有源植入式医疗器械
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2022年3月：IIa类、IIb类非植入式医疗器械
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2022年7月：I类，系统和程序包文章
US Rep
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Foreign manufacturers must appoint an US agent as a local point of contact with US FDA.
If you are a foreign manufacturer, you may appoint ARQon to act as your authorized representative in the US.
Some of the responsibilities include:
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Acting as a first point of contact with Regulatory authorities and import/customs offices
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Being responsible for pre-certification and post-approval inquiries
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Liaising between the Medical Device authority and foreign manufacturer in incident of Field Safety Corrective Action (FSCA), serious adverse event reporting to competent authorities, and in cooperation with manufacturer’s distributor
Latin America Rep
Foreign manufacturers must appoint an US agent as a local point of contact with US FDA.
If you are a foreign manufacturer, you may appoint ARQon to act as your authorized representative in the US.
Some of the responsibilities include:
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Acting as a first point of contact with Regulatory authorities and import/customs offices
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Being responsible for pre-certification and post-approval inquiries
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Liaising between the Medical Device authority and foreign manufacturer in incident of Field Safety Corrective Action (FSCA), serious adverse event reporting to competent authorities, and in cooperation with manufacturer’s distributor
ASEAN / ASIA Rep
近年来，随着监管要求的快速增长以及海关清关过程中遇到的挑战，在东盟市场获得当地政府的产品批准和进入市场变得越来越具有挑战性。
许多公司已将监管事务外包，直接聘请监管咨询公司来处理所有复杂的监管要求，这为公司在许可证持有、便捷地指定分销商以及代表公司应对地方当局的期望等方面提供了更多选择。选择合适的当地代表同样重要，因此了解当地代表提供的服务和网络至关重要。
ARQon 是一家获得 ISO13485 认证的公司，在新加坡拥有制造商许可证、进口商许可证和批发商许可证，由背景多元化的技术专家组成，并在东盟地区和全球拥有广泛的网络。
无论您是本地制造商还是外国制造商，ARQon 都能为您提供以下帮助：
成为您所在国家/地区的当地代表。
提交所有产品分类的产品注册信息。
建立符合 ISO13485、GDP 和 CE 标准的质量管理体系和技术文件。
持有该国的产品许可证。
产品许可证转让给分销商（当制造商在该国找到其首选分销商后）
指定多家进口商和分销商。
