Australia
8 articles
Asia-Pacific Medical Device Registration: Market Comparison and Entry Strategy (2026)
Compare medical device registration across APAC markets — China, Japan, South Korea, Australia, Singapore, India, ASEAN — including timelines, fees, reliance pathways, and strategic entry order.
Australia ARTG Sponsor Map: Who Controls Market Access for 63,000 Devices?
Analysis of Australia's ARTG reveals 3,377 sponsors managing 63,131 device listings — top 10 sponsors control 22%, and Emergo Australia represents 375 overseas manufacturers.
Australia Medical Device Registration Cost: Sponsor Pricing Guide (2026)
Buyer-side guide to Australia medical device registration costs, sponsor pricing models, flat fees versus hourly billing, and 3-year cash flow for ARTG inclusion across device classes.
MDSAP Audit Preparation: Complete Guide for Medical Device Manufacturers (2026)
Everything you need to prepare for an MDSAP audit — the 2026 updated audit approach (AU P0002.010), QMSR alignment, step-by-step preparation checklist, costs, timelines, and common nonconformities.
Global CE Mark Reliance Map for Medical Device Manufacturers
See where CE marking supports device approvals across 25+ markets, including full reliance, abridged review, evidence acceptance, and remaining local steps.
Medical Device Regulatory Consulting Hourly Rates by Region (2026)
Benchmark medical device regulatory consulting rates by region and consultant tier, with cost drivers and budgeting guidance for registration projects in major markets.
MDSAP Audit: The Complete Guide to the Medical Device Single Audit Program
Everything about MDSAP — the single audit program covering FDA, Health Canada, TGA, ANVISA, and MHLW. Audit process, grading, preparation, costs, and how to pass.
Australia TGA Medical Device Registration: The Complete Guide
How to register medical devices with Australia's TGA — classification, ARTG inclusion, sponsor requirements, MDSAP, fees, and practical guidance for the Australian market.