News, insights and highlights
Volume August 2022
ARQon launches a B2B International Medical Digital Platform that connects your business and showcase the variety of products and services globally.
ARQon will be participating in this year's MEDICA Trade Fair 2022 in Düsseldorf, Germany from 14-17 November 2022. The international trade fair with forums and conferences ranging from medical technology, medical imaging, IT systems, and many more. This is an opportunity for ARQon to broaden its network and exposure.
A partnership between ARQon and Singapore Health Services (SingHealth) seeks to build and aim for better healthcare equipment and services.
ASEAN / Asia
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.
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:
Acting as a first point of contact with Regulatory authorities and import/customs offices
Being responsible for pre-certification and post-approval inquiries
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
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:
European Medical Device Regulation (MDR 2017/745), with 3 years transition and extended until effective on 26 May 2021
In-vitro Diagnostic Medical Device Regulation (IVDR 2017/746), with 5 years transition until effective on 26 May 2022
EU MDD/AIMDD/IVDD directives
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.
Global standard throughout the world ISO 10993
Every website has a story, and your visitors want to hear yours. This space is a great opportunity to give a full background on who you are, what your team does, and what your site has to offer. Double click on the text box to start editing your content and make sure to add all the relevant details you want site visitors to know.
Digitalization in healthcare
Innovation cycles in healthcare are becoming shorter due to the progress of digitalization, and knowledge is becoming more fast-moving. With MEDICA DEEP DIVE, we are giving trends and insights a stage even before MEDICA in November - live online on your screen.
Medical Fair Asia 2022
The new experience – a live 3-day exhibition in Marina Bay Sands, Singapore, and a week-long digital extension, will ensure exhibitors and visitors can continue networking and doing business with a global audience.
Use this space to introduce yourself and share your professional history.
Gazette Volume 2022