AUSTRALIAN MEDICAL DEVICE FRAMEWORK
Medtechnica Services operates within the Australian medical device regulatory framework administered by the Therapeutic Goods Administration (TGA). We assist healthcare facilities and equipment owners in meeting their obligations across device registration, electrical safety certification, and ongoing performance compliance.
Our compliance practice covers the full lifecycle of a medical device — from TGA registration and ARTG listing at import, through RCM electrical safety marking, to annual AS/NZS 3551 safety testing and calibration. Each engagement produces documented evidence suitable for accreditation audits, insurance, and regulatory record-keeping.
Therapeutic Goods Administration
Device classification — confirming the GMDN classification and risk class applicable to the device.
Evidence compilation — assembling technical documentation, conformity evidence, and manufacturer authorisation.
ARTG listing — submission and listing on the Australian Register of Therapeutic Goods.
Ongoing maintenance — maintaining listing currency and managing variations or re-registrations.
Medical devices supplied in Australia must be entered on the Australian Register of Therapeutic Goods (ARTG) by the TGA before they may be lawfully supplied. Medtechnica assists clients with the registration process, working through classification, evidence compilation, and submission.
We help confirm the applicable device classification, compile the required conformity documentation from the manufacturer, and support the ARTG listing submission. Once listed, we assist with maintaining the registration's currency — including variations, re-registrations, and record-keeping obligations placed on the sponsor.
ARTG listing requirement: every medical device imported and supplied in Australia requires a current ARTG entry held by an Australian sponsor. We act as a knowledgeable interface between manufacturers, sponsors, and the TGA throughout this process.
The Regulatory Compliance Mark (RCM) is the compliance triangle-logo marking indicating that a device meets applicable Australian electrical safety and electromagnetic compatibility (EMC) requirements. For medical electrical equipment, the RCM signifies conformity with the relevant electrical safety standard.
Medtechnica assists clients in confirming that supplied equipment carries valid RCM compliance, and that electrical safety is verified during installation and maintained through annual testing. Where equipment is modified or repaired, we assess the ongoing validity of the RCM compliance status.
Electrical Safety
Verified at install & annually
EMC Conformity
Confirmed on supplied devices
The RCM indicates a device meets Australian electrical safety and EMC requirements. We verify compliant marking and maintain safety status through scheduled testing.
AS/NZS 3551 is the joint Australian/New Zealand standard governing the management of medical electrical equipment. It defines the requirements for the ongoing program of safety inspection and performance verification that keeps medical devices fit for service throughout their operational life.
Annual testing to AS/NZS 3551 is the recognised mechanism for demonstrating that medical electrical equipment remains electrically safe and continues to perform within specification. Our testing program is structured to this standard and produces documentation aligned with its requirements.
What our calibration reports include:
Protective earth continuity, enclosure and patient leakage current, and insulation resistance measured against standard limits.
Functional checks confirming the device's measured outputs remain within the manufacturer's specified tolerances.
A scheduled annual program maintains continuous compliance status and prevents lapses in safety verification.
Each tested device receives an AS/NZS 3551-aligned certificate retained for audit and accreditation purposes.
STANDARDS & FRAMEWORKS
Our compliance and servicing activities are aligned with the Australian regulatory standards and international quality frameworks governing medical devices.
Therapeutic Goods Administration — the Australian regulator responsible for medical device approval, listing on the ARTG, and post-market oversight.
Regulatory Compliance Mark — the compliance mark indicating conformity with Australian electrical safety and electromagnetic compatibility requirements.
The joint standard for the management of medical electrical equipment — defines annual safety inspection, performance verification, and calibration requirements.
International quality management system standard specific to medical devices — governing design, production, and servicing processes for device conformity.
The series of joint standards adopting IEC 60601 — specifying essential safety and performance requirements for medical electrical equipment.
Australian Register of Therapeutic Goods — the public register of devices lawfully supplied in Australia, maintained by the TGA.
DOCUMENTATION
Each service engagement produces documented evidence retained for accreditation audits, insurance, and regulatory record-keeping.
Per-device certificates recording measured values, applied tolerances, instrument traceability, and pass/fail status.
AS/NZS 3551-aligned electrical safety test reports documenting earth continuity, leakage current, and insulation results.
ARTG listing references, manufacturer conformity evidence, and sponsor documentation supporting lawful supply.
Maintained service and compliance history per asset, enabling continuous demonstration of regulatory status over time.
Medtechnica Services adheres to the Therapeutic Goods Advertising Code and relevant TGA advertising guidelines. The information presented on this website describes equipment functions, technical services, and compliance standards only. It does not make therapeutic claims, and does not promote any device for a clinical use beyond its registered purpose. Product descriptions are factual and refer to device function and regulatory status rather than clinical outcomes.
GET IN TOUCH
Whether you need TGA registration support, annual AS/NZS 3551 testing, or a compliance documentation review, our team can assist. Contact us for a tailored quotation within one business day.
Address
QLD 4000, Australia
Phone
07 0000 0000
services@medtechnicaservices.com.au