MEDICAL DEVICE REGULATION IN JAPAN
Medical devices are regulated by the Pharmaceuticals and Medical Devices Agency from the Ministry of Health, Labour and Welfare (MHLW) whose objective is to improve the public health and safety of Japan by reviewing applications for marketing approval of medical devices, conducting safety measures, and providing relief to people who have suffered from adverse reactions. Medical devices are regulated under the Pharmaceuticals and Medical Devices Act.
Japan is one of the member countries in the current IMDRF (also the founder members of the previous GHTF). Japan has been involved in the drafting process of IMDRF/GHTF documents, in principle, the country also updates their regulation in alignment to IMDRF/GHTF harmonization initiatives actively. These include the 4 risk classification, essential principles, quality system as well as its audit.
MEDICAL DEVICE REGISTRATION AND APPROVAL IN JAPAN
Medical devices are classified in the table below (Class I being the lowest risk category while Class IV is the highest risk category):
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.