Overview of Services

ARQon – Regulatory

ARQon provides regulatory services and guidance to overseas and local MedTech companies. Our services include:

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.

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:

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.

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.

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.

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.

Commercialization and business matching

Our commercial team supports clients for business setup, marketing, IT, distributor search as well as networking for relevant industry players.

Rushes Group

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Services - ARQon International Business Group

PRODUCT REGISTRATION
(ASEAN, ASIA, EU, Global)

IN-COUNTRY REPRESENTATIVE/ LICENSE HOLDING
(ASEAN, ASIA, EU, Global)

Global Regulatory Strategy

Technical File/Medical Device File Setup
(EU, US and ASEAN Compliance)

Commercialization and business matching

Importation Flowchart (ARQon License Holder)

Need more details?
We are here to assist. Contact us at ATTOPOLIS.

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Services - ARQon International Business Group

PRODUCT REGISTRATION (ASEAN, ASIA, EU, Global)

IN-COUNTRY REPRESENTATIVE/ LICENSE HOLDING (ASEAN, ASIA, EU, Global)

Importation Flowchart (ARQon License Holder)

PRODUCT REGISTRATION
(ASEAN, ASIA, EU, Global)

IN-COUNTRY REPRESENTATIVE/ LICENSE HOLDING
(ASEAN, ASIA, EU, Global)