Medical Devices
Medical device manufacturers in Europe seeking to enter the Australia market must comply with local medical device regulations and demonstrate conformity through comprehensive technical documentation. Therapeutic Goods Administration (TGA) oversees medical device regulation in Australia, requiring manufacturers to establish proper representation and meet stringent safety and performance requirements.
Taylored Consultancy provides complete medical device regulatory support for Europe companies expanding to Australia. Our services include device classification, technical file preparation, clinical evaluation, UK Responsible Person (UKRP) or EC Representative (EC-REP) services, and ongoing post-market surveillance to ensure full compliance throughout your product lifecycle.
Comprehensive classification under Australian Therapeutic Goods (Medical Devices) Regulations 2002, risk class determination, and conformity assessment pathway selection.
Australian Register of Therapeutic Goods (ARTG) inclusion application, evidence of conformity preparation, and TGA submission management for Australia market authorization.
TGA sponsor responsibilities assessment, manufacturer evidence compilation, conformity assessment certificates, and quality management system verification for Australia.
Complete technical file preparation meeting Australian requirements, including design verification, clinical evidence, risk management, and manufacturing documentation.
Evidence of conformity to Essential Principles, certification documentation, third-party assessment coordination, and ongoing compliance demonstration for TGA approval.
Adverse event reporting systems, recall procedures, post-market surveillance obligations, and continuous TGA compliance monitoring for Australia market authorization.
