Commonwealth of Australia Product Registration & Certification
Important Notes
- TGA Centralized Regulation & ARTG Listing: All medicines, medical devices, and complementary medicines must be registered with the Therapeutic Goods Administration (TGA) and listed on the Australian Register of Therapeutic Goods (ARTG) as the sole prerequisite for legal supply.
- Risk-Based Product Classification & Pathway: Medical devices strictly follow the EU IMDRF classification framework (Class I-IV) with evidence-based registration routes; cosmetics are regulated as "consumer goods" with no pre-market approval but strict post-market surveillance by ACCC under the Consumer Law.
- Complementary Medicines as a Statutory Category: Vitamins, herbs, nutritional supplements are classified as "Complementary Medicines," falling under the medicines category alongside pharmaceuticals, requiring ARTG listing with strict management of their "listed" (lower risk) or "registered" (higher risk) status.
- Local Sponsor Legal Responsibility: Foreign manufacturers must appoint a local Australian entity (company or individual) as the "Sponsor," who assumes all legal responsibilities for registration, quality, safety, and post-market vigilance.
- Stringent Evidence Requirements for Labeling & Claims: All "therapeutic use" claims (including health claims for complementary medicines) must be supported by TGA-accepted evidence, either "traditional use" or scientific evaluation. Unsubstantiated efficacy claims are prohibited.
- Mutual Recognition Agreements (MRA) & Acceptance of Overseas Certifications: TGA has MRAs with regulators like EU, Canada, and Singapore. Certifications obtained in these countries (e.g., CE Marking) can significantly streamline the assessment for some medical devices and medicines.
Australia Specific Requirements
- Mature Market with High Threshold, Standards & Reputation: TGA regulation is renowned for its rigor, transparency, and science-based approach. Its approval carries significant international credibility, providing a strong quality endorsement.
- Strict Dual Regulation of the "Complementary Medicines" Market: The market is large but maturely regulated. Products are divided into lower-risk "Listed medicines" (based on pre-approved ingredients and traditional claims) and higher-risk "Registered medicines" (requiring scientific evaluation), with clear but high compliance pathways.
- Strong Responsibility Chain under the Sponsor System: The local Sponsor is the absolute legal core, necessitating deep, trustworthy partnerships and comprehensive supply chain traceability and quality agreements.
- Proactive Regulatory Reform & Digitalization Trends: TGA continuously modernizes regulations, e.g., refining medical device classification rules, accepting real-world evidence, and strongly promoting electronic submissions and database transparency.
- Highly Rational Consumers & Professionalized Channels: Consumers are sensitive to product safety and the science behind claims, heavily reliant on pharmacy channels and healthcare professional advice. Brand reputation and clinical evidence are key to market success.
Medical Devices Registration
Regulatory Requirements
- Australian Register of Therapeutic Goods (ARTG) Certificate
- Risk classification per Medical Device Regulation Schedule 1 (Class I, IIa, IIb, III, AIMD)
- Complete Technical Documentation (Design Verification, Validation, Risk Management)
- TGA-recognized ISO 13485:2016 Quality Management System Certificate
- English labeling and IFU compliant with AS/NZS 4417.1
- Conformity Assessment Pathway: TGA Audit or EU CE MDR/IVDR Certificate
- Formal Appointment of Australian Sponsor
- Clinical Evidence documentation (Clinical Evaluation Report, PMCF for Class IIb/III)
- Post-Market Surveillance Plan
- Declaration of Conformity
- Unique Device Identification (UDI) Implementation Plan
- Product Change Control Procedure Documents
Main Process
- Product Classification Confirmation (Annex 1 Classification Rules)
- Sponsor Qualification Assessment and Contract Execution
- Selection of Conformity Assessment Pathway
- Compilation of Complete Technical Documentation
- Conduct Necessary Clinical Evaluation or Verification
- Submission of ARTG Application (Medical Device Application)
- TGA Technical Review and Possible Site Audit
- Receipt of ARTG Registration Certificate
- Implementation of Post-Market Surveillance System
Registration Timeline
Class I: 1-3 months
Class IIa: 4-8 months
Class IIb: 6-12 months
Class III/AIMD: 9-24 months
Official Fees
Application Fee: $1,150 - $58,200 AUD
Annual Retention Fee: $1,050 - $53,400 AUD
Conformity Assessment Fee: $5,000 - $120,000 AUD
Service Fees
Class I: $15,000 - $25,000
Class IIa: $25,000 - $45,000
Class IIb: $40,000 - $70,000
Class III: $60,000 - $120,000
Regulatory System Overview
TGA
Therapeutic Goods Administration
Under the Australian Government Department of Health and Aged Care, exercising authority under the Therapeutic Goods Act 1989, responsible for pre-market approval, quality management, post-market surveillance, and market regulation of therapeutic goods nationwide.
AICIS
Australian Industrial Chemicals Introduction Scheme
Responsible for regulation of industrial chemicals used in cosmetics and other products, managing chemical risk assessment and approval under the Industrial Chemicals Act 2019, replacing the former NICNAS system.
ACCC
Australian Competition and Consumer Commission
Exercising authority under the Australian Consumer Law 2010, responsible for product safety supervision, mandatory standards enforcement, consumer rights protection, and product recall management, regulating advertising claims for cosmetics and medical devices.
OGTR
Office of the Gene Technology Regulator
Responsible for risk assessment and management of gene technology products, specialized regulation and approval of therapeutic goods and foods containing genetically modified ingredients.
Medical Devices Registration Process
Regulatory Classification & Pathway Planning
Determine risk classification according to Medical Device Regulation Schedule 1, establish conformity assessment pathway (TGA direct assessment or EU CE certificate conversion)
Sponsor Legal Framework Establishment
Appoint qualified Australian Sponsor, execute formal agreement, establish legal responsibility framework complying with Sponsor Obligations
Technical Documentation Compliance Preparation
Compile complete technical documentation: design verification, risk analysis (ISO 14971), clinical evaluation (Class IIa+), performance verification, stability data
Conformity Assessment Completion
Obtain Conformity Assessment Certificate through selected pathway: TGA audit or EU Notified Body assessment
ARTG Application Submission
Submit complete application through TGA Business Services (TBS) portal, including all supporting documents and declaration information
Technical Review & Approval
TGA conducts technical review (Class I: 5-15 working days; Class III: 120-240 working days), may request additional information or audits
Post-Registration Compliance Management
Receive ARTG ID, implement UDI system, establish PMS, submit Annual Charge, manage change notifications
Cosmetics Registration
Regulatory Requirements
- Australian Industrial Chemicals Introduction Scheme (AICIS) Registration
- Safety Assessment Report by Qualified Assessor
- Good Manufacturing Practice Certificate compliant with AS/NZS 4397:1996
- English Product Labeling (Mandatory ingredient declaration, warnings)
- Ingredient Compliance Certificate (per Australia Industrial Chemicals Act)
- Cosmetic Product Information File
- Appointment of Australian Responsible Person
- Adverse Event Monitoring and Reporting System
- Stability Testing Data (Accelerated Stability Testing)
- Microbiological Limit Test Reports
- Toxicological Risk Assessment
- Packaging Material Compliance Assessment
Main Process
- AICIS Registration Confirmation for Ingredients
- Safety Assessment and Toxicological Dossier Establishment
- Responsible Person Qualification Assessment and Appointment
- GMP Compliance Evidence Collection
- Product Information File Compilation
- Labeling Compliance Review
- Adverse Event Reporting System Establishment
Registration Timeline
Standard Products: 3-6 months
Containing New Chemicals: 6-12 months
Products with Special Claims: 4-8 months
Official Fees
AICIS Registration Fee: $1,000 - $15,000 AUD
Annual Fee: $500 - $5,000 AUD
Change Notification Fee: $200 - $2,000 AUD
Service Fees
Standard Product Notification: $8,000 - $18,000
Products with New Ingredients: $15,000 - $30,000
Product Series Notification: $12,000 - $25,000
Regulatory System Overview
TGA
Therapeutic Goods Administration
Under the Australian Government Department of Health and Aged Care, exercising authority under the Therapeutic Goods Act 1989, responsible for pre-market approval, quality management, post-market surveillance, and market regulation of therapeutic goods nationwide.
AICIS
Australian Industrial Chemicals Introduction Scheme
Responsible for regulation of industrial chemicals used in cosmetics and other products, managing chemical risk assessment and approval under the Industrial Chemicals Act 2019, replacing the former NICNAS system.
ACCC
Australian Competition and Consumer Commission
Exercising authority under the Australian Consumer Law 2010, responsible for product safety supervision, mandatory standards enforcement, consumer rights protection, and product recall management, regulating advertising claims for cosmetics and medical devices.
OGTR
Office of the Gene Technology Regulator
Responsible for risk assessment and management of gene technology products, specialized regulation and approval of therapeutic goods and foods containing genetically modified ingredients.
Cosmetics Registration Process
Chemical Regulatory Compliance Verification
Confirm all ingredients have AICIS registration per Industrial Chemicals Act, assess need for exemptions or additional declarations
Safety Assessment & Toxicology Dossier
Prepare complete safety assessment report by Qualified Safety Assessor, including toxicological data and risk analysis
Legal Appointment of Responsible Person
Designate Australian-based Responsible Person, establish legal framework ensuring clear compliance responsibilities
GMP & Quality Management System
Manufacturing site provides AS/NZS 4397 GMP compliance certificate, establishes comprehensive quality control system
Product Information File Establishment
Compile complete Product Information File (PIF) containing formulation, manufacturing process, quality control, stability data, safety dossier
Labeling & Advertising Compliance Review
Ensure labels fully comply with Trade Practices Act and ACCC requirements, all claims scientifically supported
Post-Market Safety Monitoring
Establish product adverse event monitoring system, report to regulators as required, execute necessary market recalls
Complementary Medicines (Listed/Registered Medicines) Registration
Regulatory Requirements
- ARTG Registration Certificate (per Schedule 4 or Schedule 10)
- Evidence Documents for Quality, Safety, and Efficacy
- Scientific Evidence Supporting Therapeutic Claims (per Evidence Guidelines)
- TGA GMP Certification (Manufacturing Site Audit)
- English Product Labeling compliant with Therapeutic Goods Labeling Order
- Product Specifications and Stability Study Data
- Australian Sponsor Appointment and Qualification Documents
- Pharmacovigilance System
- Risk Management Plan
- Good Laboratory Practice Study Data
- Drug Master File or CTD Format Submission
- Product Information Document
Main Process
- Product Category Determination (Listed vs Registered)
- Sponsor Qualification Assessment and Appointment
- Evidence Package Establishment
- Manufacturing Site TGA GMP Audit
- Registration Dossier Compilation (CTD Format)
- ARTG Application Submission and Review
- Product Information Approval and Labeling Review
Registration Timeline
Listed Medicines: 2-5 months
Registered Medicines (Standard): 8-16 months
Registered Medicines (Assessed): 12-24 months
Official Fees
Listed Medicines: $1,030 - $5,150 AUD
Registered Medicines: $10,000 - $55,000 AUD
GMP Audit Fee: $15,000 - $60,000 AUD
Service Fees
Listed Medicines: $15,000 - $35,000
Registered Medicines: $40,000 - $100,000
Products with Clinical Trials: $80,000 - $200,000
Regulatory System Overview
TGA
Therapeutic Goods Administration
Under the Australian Government Department of Health and Aged Care, exercising authority under the Therapeutic Goods Act 1989, responsible for pre-market approval, quality management, post-market surveillance, and market regulation of therapeutic goods nationwide.
AICIS
Australian Industrial Chemicals Introduction Scheme
Responsible for regulation of industrial chemicals used in cosmetics and other products, managing chemical risk assessment and approval under the Industrial Chemicals Act 2019, replacing the former NICNAS system.
ACCC
Australian Competition and Consumer Commission
Exercising authority under the Australian Consumer Law 2010, responsible for product safety supervision, mandatory standards enforcement, consumer rights protection, and product recall management, regulating advertising claims for cosmetics and medical devices.
OGTR
Office of the Gene Technology Regulator
Responsible for risk assessment and management of gene technology products, specialized regulation and approval of therapeutic goods and foods containing genetically modified ingredients.
Complementary Medicines (Listed/Registered Medicines) Registration Process
Product Category & Pathway Determination
Determine if product is Listed Medicines (AUST L) or Registered Medicines (AUST R), classify per Schedule 4 or Schedule 10
Scientific Evidence Package Establishment
Prepare complete quality, safety, and efficacy evidence package per TGA Evidence Guidelines
GMP Certification & Manufacturing Control
Manufacturing site obtains TGA GMP certification, establishes comprehensive quality control system, prepares drug master file
Sponsor Legal Framework
Appoint qualified Australian Sponsor, establish legal compliance framework ensuring Sponsor Obligations compliance
CTD Format Dossier Preparation
Prepare complete registration dossier in Common Technical Document format (Module 1-5)
TGA Scientific Evaluation & Approval
TGA conducts scientific evaluation (Listed: 20-40 working days; Registered: 120-240 working days), may request additional information or expert committee review
Post-Market Compliance Management
Receive ARTG ID, establish pharmacovigilance system, execute Periodic Safety Update Reports, manage change notifications and annual renewals