🇦🇺 Live Medical Devices & Diagnostics

Australian Therapeutic Goods Act 1989

Regulates the import, export, manufacture, and supply of therapeutic goods in Australia.

View official source document

Rules extracted

199

Obligations decomposed

15.3x

Avg obligations per rule

🇦🇺 Australia

Jurisdiction

About this regulation

The Therapeutic Goods Act 1989 establishes a national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods used in or exported from Australia. It establishes the Australian Register of Therapeutic Goods (ARTG) and provides for the registration, listing, and inclusion of medicines, medical devices, and biologicals. The Act is administered by the Therapeutic Goods Administration (TGA) within the Department of Health and Aged Care.

What AuditDSS covers

Source

Regulation

Extracted

Rules

Decomposed

199

Obligations

15.3x

Decomposition ratio

Each rule is decomposed into an average of 15.3 atomic obligations — the smallest testable units that can be independently violated.

Fully extracted & scored

All 199 obligations have been decomposed, titled, risk-scored, and embedded for semantic matching.

Risk scoring

Every obligation in TGA Act 1989 is scored across independent risk dimensions:

Obligation Weight

How critical within the regulatory framework

Violation Likelihood

How often breached in practice

Enforcement Evidence

Regulator enforcement history and penalties

Cascade Dependency

How many obligations depend on this one

Regulatory details

Full title: Australian Therapeutic Goods Act 1989
Regulatory body: Therapeutic Goods Administration
Jurisdiction: 🇦🇺 Australia
Document type: act
Effective date: February 15, 1991
Issuing authority: Parliament of Australia
Industry: Medical Devices & Diagnostics
Official source: View source document ↗

Who this applies to

therapeutic goods sponsorsmanufacturersimportersadvertisersclinical trial sponsorspharmacistsprescribers

Key requirements

ARTG registration/listing
conformity assessment for medical devices
GMP compliance
adverse event reporting
advertising restrictions
scheduling compliance
clinical trial notification

Frequently asked questions about TGA Act 1989

What is TGA Act 1989?

Who does TGA Act 1989 apply to?

TGA Act 1989 applies to therapeutic goods sponsors, manufacturers, importers, advertisers, clinical trial sponsors, pharmacists, prescribers.

How many obligations does TGA Act 1989 contain?

AuditDSS has decomposed TGA Act 1989 into 199 atomic obligations from 13 rules. Each obligation is independently testable and risk-scored.

What are the key requirements of TGA Act 1989?

The key requirements include: ARTG registration/listing, conformity assessment for medical devices, GMP compliance, adverse event reporting, advertising restrictions, scheduling compliance, clinical trial notification.

How can I assess my TGA Act 1989 compliance?

Upload your compliance policy to AuditDSS. The platform maps your document against all 199 TGA Act 1989 obligations using deterministic AI scoring — not checklists or LLM summaries. You get a risk-scored gap analysis showing exactly which obligations are covered, partially covered, or missing.

Which jurisdiction enforces TGA Act 1989?

TGA Act 1989 is enforced in Australia by Therapeutic Goods Administration.

When did TGA Act 1989 come into effect?

TGA Act 1989 became effective on February 15, 1991.

What industry does TGA Act 1989 apply to?

TGA Act 1989 is primarily relevant to the Medical Devices & Diagnostics industry. AuditDSS covers 64 regulations in this industry sector.

Build a TGA Act 1989 compliance pack

Don't have a compliance policy yet? AuditDSS generates a complete compliance pack for TGA Act 1989 — alone or combined with other regulations your business needs. Every clause is mapped to specific obligations.

Policy

High-level commitments and governance framework covering TGA Act 1989 requirements.

Procedures

Step-by-step operational procedures to implement each policy commitment.

Forms & checklists

Ready-to-use forms, registers, and checklists for day-to-day compliance operations.

Multi-regulation

Combine TGA Act 1989 with other regulations into a single unified compliance pack for your business.

Build TGA Act 1989 compliance pack

Already have a policy? Assess it against TGA Act 1989

Upload your document

Upload your compliance policy, program manual, or operational document. AuditDSS accepts any text-based document.

AI maps against 199 obligations

Your document is scored against every obligation in TGA Act 1989. Each claim is mapped to the obligation tree and evaluated for coverage.

Risk-scored gap report

Receive every gap ranked by risk priority with remediation guidance, enforcement evidence, and cascade impact analysis.