MEDICAL DEVICE REGULATION IN TAIWAN
Medical devices are is regulated by the Taiwan Food and Drug Administration (TFDA) from the Ministry of Health and Welfare (MOHW) in Taiwan whose objective is to safeguard the national health and lead the nation to a new era of medical device management. Medical devices are regulated under the Pharmaceutical Affairs Act.
MEDICAL DEVICE REGISTRATION AND APPROVAL IN TAIWAN
Medical devices are classified into 3 categories namely class I, II, and III (I being the lowest risk and III being the highest risk).
Devices which are made and approved in US or EU would go under an easier registration route.
The classification in Taiwan was referenced from US FDA classification, hence there is a similarity between having 3 classes in Taiwan.
Class I requires simple registration with TFDA.
Class II and III registration with TFDA must be submitted with the dossier containing elements in STED (Summary Technical Documentation), in addition to other administrative legalization documents.
The registration process with TFDA requires good communication as the evaluation is quite in depth in Taiwan.
The ARQon team also experiences a product approval process from consumer products to the professional-use of medical devices in Class II and III.
ARQon also assists manufacturers in the QSD application with the customization for the TFDA quality system requirements procedure into the manufacturer's Quality Management System (QMS).
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:
Be your local representative in the country.
Submit product registrations for all product classifications.
Set up the QMS & technical file for ISO13485, GDP and CE
Hold product license in the country.
Transfer product license to distributor (when manufacturer secure its preferred distributor in the country)
Appoint multiple importers and distributors.