License Holding
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
Switzerland is preparing a national Medical Device ordinance (MepV), as reported by Swiss MedTech. The country is thus prepared to no longer be a direct part of the EU system, Because the negotiations with the EU are likely to fail. Due to these changes, manufacturers from outside Switzerland are only allowed to market their medical devices in Switzerland if they have a Swiss Rep.
Transition periods discussed in this context are:
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December 2021: Class III, Class IIb implantable devices, active implantable devices
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March 2022: Class IIa, Class IIb non-implantable devices
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July 2022: Class I, Systems and procedure packs Article
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
Gaining product approval from local authority and market entry has been more and more challenging in the ASEAN market over the years with rapid increase in regulatory requirement and challenges encountered during the custom clearance.
Many companies have outsourced their regulatory to simply appointing Regulatory consultancy firm to handle all the challenging regulatory requirement and opens up more options for the companies in terms of license holding, ease of appointing various distributors and acting on behalf of the company to face the expectations from the local authorities. The choice of your local representative is equally important so it is important to understand what the service and network coming from your local representative.
ARQon is a certified ISO13485 company that has manufacturer’s license, importer license and wholesaler license in Singapore, comprise of diverse background technical experts, and vast network in the ASEAN region and globally.
Whether you are a local or foreign manufacturer, ARQon can assist to:
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Be your local representative in the country.
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Submit product registrations for all product classifications.
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Set up the QMS & technical file for ISO13485, GDP and CE
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Hold product license in the country.
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Transfer product license to distributor (when manufacturer secure its preferred distributor in the country)
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Appoint multiple importers and distributors.
