MEDICAL DEVICE REGULATION IN AUSTRALIA
Medical devices are regulated by the Therapeutic Goods Administration (TGA) in Australia whose aim is to ensure the Australian community has access within a realistic time frame to therapeutic goods by evaluating and monitoring devices that are of an acceptable standard. Medical devices are regulated under the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods (Medical Devices) Regulations 2002.
MEDICAL DEVICE REGISTRATION AND APPROVAL IN AUSTRALIA
Therapeutic goods (medical devices) must be included on the Australian Register of Therapeutic Goods (ARTG) before the device can be supplied in Australia.
Medical device (non-IVD) in Australian are classified into 4 categories namely class I, IIa, IIb and III (Similar to EU Classification).
IVD products in Australia are classified into class 1 IVD, 2 IVD, 3 IVD, and 4 IVD.
For medical devices (except class I devices, non-sterile and non-measuring), a manufacturer must hold an acceptable Conformity Assessment Certificate for the medical device to be included on the ARTG.
For devices with EC certification, the ARTG inclusion process will be much easier. The EC Conformity Assessment certification should be issued by an acceptable EU Notified Body in accordance to the Medical Device Directive 93/42/EEC (MDD) or In-Vitro Diagnostic Medical Devices Directive (IVDD), or ISO 13485 Certificates for IVD.
High-risk medical devices require TGA Conformity Assessment and the EC certification is not an acceptable evidence of compliance.
Medical devices must be included on the ARTG before the device can be imported and/or supplied in Australia.
Example Of Approval
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.