Overview of Services - ARQon International Business Group
ARQon – Regulatory
ARQon provides regulatory services and guidance to overseas and local MedTech companies. Our services include:
1. Product Registration (ASEAN, ASIA, EU, Global)
The submission checklist requirements can vary depending on each country. The registration team with vast industry and ex-regulatory experiences can support client to obtain approval strategically and efficiently by navigating the complex regulatory and market objectives.
2. In-Country Representative/License Holding (ASEAN, ASIA, EU, Global)
ARQon can be the license holder/authorized representative if client/manufacturer does not have a local company. This provides the client with the flexibility to appoint or change distributors in the country and the option to sell direct to customers with their own sales team. The licenses can be transferred back to the client if required.
MedtechBOSS - Compliance & Commercialization
MedtechBOSS provides a one-stop solution to clients for regulatory compliance and commercialization. The team helps clients, especially start-up companies, to grow their business presence globally. Our services include:
1. Global Regulatory Strategy
We help clients to establish effective regulatory strategies for market access and penetration by understanding the regulatory pathway and its regulations in quality system, technical and clinical requirements which is essential for budgeting and planning of time and resources.
2. Technical File/Medical Device File Setup (EU, US and ASEAN Compliance)
Our team of engineers, clinical experts and regulatory consultants have helped variety of clients to set up their technical file which consists of information such as designs, testing, clinical evaluation and risk management, to demonstrate compliance with applicable regulatory requirements for different authorities.
3. Quality Management System Setup (EN & US QSR Compliance)
Authorities require MedTech companies who deal with medical devices to establish quality management systems such as ISO 13485 (for manufacturers) or GDP (for importers and distributors) to ensure processes and activities are properly managed. Our consultants, with extensive experience as lead auditors, can help clients to set up their own quality systems that comply with EN and US QSR requirements.
4. License Tapping (Singapore)
Companies can opt to tap on MedtechBOSS dealer licenses (importer and distributor) in which they can import and distribute their products in Singapore using our licenses. This way, companies can start commercial activities with lower cost as they no longer need to set up their own quality systems and apply for dealer licenses to comply to regulations.
5. Commercialization and business matching
Our commercial team supports clients for business setup, marketing, IT, distributor search as well as networking for relevant industry players.
IMDS – Training
International Medical Device School organizes training annually for MedTech professionals, for them to understand the medical device lifecycle, from design, manufacturing, regulatory approval to commercialization.
ATTOPOLIS – B2B Community Platform
A B2B platform that gathers all players in MedTech industry and provides them an avenue to market their services or products. A one stop platform that promotes networking for all MedTech Professionals and Companies. Join this complimentary medical community.
Importation Flowchart (ARQon License Holder)
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