Question 1

What is TGA and why is it important for medical device manufacturers?

Accepted Answer

The Therapeutic Goods Administration (TGA) is Australia's regulatory authority for therapeutic goods including medical devices, operating under the Therapeutic Goods Act 1989. TGA oversees the Australian Register of Therapeutic Goods (ARTG), conducts conformity assessments, enforces quality standards, and performs post-market surveillance. All medical devices marketed in Australia must be included in the ARTG, and foreign manufacturers must designate an Australian sponsor. TGA is recognized internationally for rigorous standards and participates in the Medical Device Single Audit Program (MDSAP), facilitating global regulatory alignment.

Question 2

What is ARTG and how do I include my device?

Accepted Answer

The Australian Register of Therapeutic Goods (ARTG) is the official register of medical devices (and other therapeutic goods) approved for supply in Australia. ARTG inclusion is mandatory before commercialization. Application Process: Australian sponsor designation (mandatory for foreign manufacturers), device classification (Class I, IIa, IIb, III), conformity assessment (self-assessment for Class I, third-party for higher classes), conformity assessment certificates (from TGA or recognized bodies like EU Notified Bodies), quality management system evidence (ISO 13485, MDSAP, etc.), technical documentation and labeling review. Pathways: Full Assessment: TGA conducts comprehensive evaluation, Comparable Overseas Regulator pathway: Streamlined for devices approved in EU, USA, Canada, Japan, Conformity Assessment pathway: For devices with certificates from recognized bodies. Timelines: Class I: 1-2 months, Class IIa/IIb: 3-6 months, Class III: 6-12+ months (depending on pathway and device complexity).

Question 3

What is an Australian Sponsor and what are their responsibilities?

Accepted Answer

An Australian Sponsor is a person or company established in Australia that takes legal responsibility for the therapeutic good (medical device) in Australia. Requirements: Must be domiciled in Australia (individual or company), registered as a sponsor with TGA, holds the ARTG entry for the device(s), Responsibilities: Submit ARTG inclusion applications to TGA, hold and maintain conformity assessment certificates and technical documentation, serve as primary contact with TGA for regulatory matters, conduct post-market surveillance and adverse event reporting to TGA, manage product recalls and corrective actions, ensure continued compliance with Australian standards and regulations, maintain manufacturer authorization to act as sponsor. Options for Foreign Manufacturers: Australian subsidiary of the manufacturer, Australian distributor/importer serving as sponsor, regulatory consulting firm acting as sponsor. An Australian Sponsor is mandatory for all foreign manufacturers seeking to market devices in Australia.

Question 4

How does Australia classify medical devices?

Accepted Answer

Australia uses a risk-based classification system aligned with the EU MDR: Class I: Low risk (e.g., non-invasive devices, surgical instruments), self-assessment of conformity, Australian sponsor can apply directly to TGA, Class IIa: Low-medium risk (e.g., short-term invasive, some active devices), conformity assessment by TGA or recognized body required, Class IIb: Medium-high risk (e.g., long-term invasive, contraceptive devices), third-party conformity assessment required, Class III: High risk (e.g., implantable, life-sustaining devices), most stringent conformity assessment and clinical evidence. Classification rules follow EU MDR Annex VIII, considering factors like: invasiveness, duration of use, whether device is active, intended purpose and critical nature, body systems affected. TGA provides classification guidance and manufacturers can request classification advice.

Question 5

What is MDSAP and how does it relate to TGA?

Accepted Answer

MDSAP (Medical Device Single Audit Program) is a multi-country quality management system audit program that allows manufacturers to undergo a single audit to satisfy regulatory requirements in participating countries. MDSAP Participants: Australia (TGA), USA (FDA), Canada (Health Canada), Brazil (ANVISA), Japan (PMDA/MHLW). Benefits for Australia: Single MDSAP audit satisfies TGA's QMS requirements, reduces audit burden and costs for global manufacturers, internationally recognized and accepted by TGA, facilitates ARTG inclusion process. TGA's Role: TGA recognizes MDSAP audit reports as evidence of QMS compliance, manufacturers can submit MDSAP certificates for ARTG applications, TGA may still conduct additional audits for specific concerns. Recommendation: Global manufacturers targeting multiple markets should strongly consider MDSAP to maximize efficiency, especially if planning Australia + USA + Canada + others.

Question 6

What conformity assessment pathways does TGA offer?

Accepted Answer

TGA offers several pathways for conformity assessment depending on device class and manufacturer circumstances. TGA Conformity Assessment: TGA acts as the conformity assessment body, comprehensive technical review by TGA, available for all device classes. Comparable Overseas Regulator Pathway: For devices approved in USA (FDA), EU (CE marking), Canada (Health Canada), Japan (PMDA), streamlined process relying on overseas assessment, faster timelines, lower fees. EU Notified Body Pathway: Devices with valid CE marking certificates from EU Notified Bodies, TGA recognizes EU conformity assessment, still requires ARTG inclusion application. Recommendations: Class I: Direct application to TGA (simple), Class IIa/IIb/III with FDA or CE: Use Comparable Overseas Regulator pathway (fastest), Class IIa/IIb/III without overseas approval: Consider obtaining CE first, then applying to TGA. TGA's acceptance of overseas approvals makes strategic regulatory planning important.

Question 7

How often is Australia TGA regulatory news updated and how can I stay informed?

Accepted Answer

TGA regularly publishes guidance documents, safety alerts, regulatory updates, and consultations related to medical devices, ARTG requirements, and post-market obligations. Recent focus includes digital health devices, software as medical devices (SaMD), personalized medical devices, and international harmonization. Our platform aggregates daily updates from 7 premium commercial sources including RAPS, Emergo by UL, Citeline, and Pacific Bridge Medical. We recommend checking this page regularly, subscribing to TGA's Device Update bulletin, and working with your Australian Sponsor to monitor regulatory developments.

Question 8

What commercial sources does this platform use for Australia news?

Accepted Answer

We aggregate Australian regulatory intelligence from 7 premium sources: RAPS (Regulatory Affairs Professionals Society), Emergo by UL, Citeline MedTech Insight, Pacific Bridge Medical, Asia Actual, Pure Global's proprietary research, and Qualtechs. These sources provide expert analysis, real-time updates, and strategic insights beyond basic TGA announcements, helping you navigate ARTG inclusion pathways, Australian sponsor designation, conformity assessment options, MDSAP benefits, and comparable overseas regulator strategies.

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