Medical Devices

Medical Devices Compliance for European Companies Expanding to Australia

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.

Technical File Creation

We compile and review your Technical File to ensure it meets all regulatory requirements, including design specifications, testing data, and risk management documentation.

Risk Management

We support risk assessments and management processes to help identify, document, and mitigate potential product risks in line with ISO 14971.

QMS Supplier Audit

Supplier compliance is critical for medical devices. We assess your suppliers’ QMS performance to ensure regulatory and quality requirements are met.

What we do

TGA Device Classification

Comprehensive classification under Australian Therapeutic Goods (Medical Devices) Regulations 2002, risk class determination, and conformity assessment pathway selection.

Sponsor Requirements

TGA sponsor responsibilities assessment, manufacturer evidence compilation, conformity assessment certificates, and quality management system verification for Australia.

Conformity Assessment

Evidence of conformity to Essential Principles, certification documentation, third-party assessment coordination, and ongoing compliance demonstration for TGA approval.

Classification

Unsure how your product is classified? We determine the correct classification, ensuring you follow the right regulatory pathway.

ARTG Registration

Australian Register of Therapeutic Goods (ARTG) inclusion application, evidence of conformity preparation, and TGA submission management for Australia market authorization.

Technical Documentation

Complete technical file preparation meeting Australian requirements, including design verification, clinical evidence, risk management, and manufacturing documentation.

Post-Market Compliance

Adverse event reporting systems, recall procedures, post-market surveillance obligations, and continuous TGA compliance monitoring for Australia market authorization.

QMS Audit Support

Facing a Notified Body audit or regulatory inspection? We provide hands-on support to help you prepare, respond, and maintain compliance throughout the process.

Testimonials

Our happy clients say about us

Bethany has a wealth of experience in medical devices and is always providing a fantastic service. Having worked with Bethany on and off over the years I can safely say I would trust her regulatory advice. Thank you Taylored & the team!

The Cosmetic Regulator

We have been working with Bethany for 3 months now and are very impressed! She is super orgainsed, very knowledgable and does it all with a smile! Would highly recommend.

George Kruis

Amazing! Went over and above working longer hours communicating with suppliers and getting all the relevant info. Quick to find solutions and overall very helpful. Thank you!

Tom Attwood

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