Medical Device Regulatory Services

TGA Submissions and ARTG Inclusions

End-to-end management of TGA submissions, ARTG applications and inclusions, and variations for medical devices entering the Australian market. TGA medical device registration is handled through ARTG inclusion.

• ARTG inclusion strategy, medical device classification, and pre-submission planning
• Maintain manufacturer relationships and confirm conformity assessment responsibilities before and after registrations.
• Document review and manufacturer evaluation
• Application drafting and electronic lodgement
• Response to TGA clarification requests
• Variation submissions for approved products
• Comprehensive audits of current registration to streamline regulatory compliance, improve and reduce regulatory costs and manage ‘scope creep’ in medical device classification.
• Consent to supply outside the Essential Principles and supply of unapproved therapeutic goods into the Australian market.
• MDD to MDR Conformity Assessment assistance
• Prosthesis list application, tender and reimbursement code assistance

• Facilitating Unique Device Identification (UDI) requirements and importing into the Australian AusUDID.

Medical Device Technical Documentation

Compilation of medical device technical documentation aligned to current TGA and international jurisdictions expectations.

• Medical device technical files
• Risk assessments and Essential Principles checklists
• Determining applicable ISO Standards
• Risk analysis and FMEA method
• Clinical Evidence Review writing
• Quality, non-clinical, and clinical overview drafting
• Gap analysis and remediation

Australian Sponsor

Acting as your Australian sponsor for medical devices under the Therapeutic Goods Act for overseas manufacturers and distributors.

• Sponsor of record for ARTG inclusions
• Maintaining documentation for Sponsor obligations for ongoing monitoring and reporting.
• Commercial in confidence communications, with your business and between regulators and manufacturers.
• Direct interface with TGA delegates
• Regulatory correspondence and reporting obligations
• Distributor authorisation management
• Prosthesis list and tender applications

Australian sponsor for overseas manufacturers →

TGA Post-Market Compliance

TGA post-market compliance, including ongoing surveillance and incident management for products on the ANZ market.

• Maintaining documentation for Sponsor obligations for ongoing monitoring and reporting.
• Distribution records
• Medical device annual reporting
• Maintaining documentation and regulatory compliance for post market audits
• Recall coordination and field corrective actions
• Adverse event responses and notifications to regulatory bodies and customers (consumer, health professionals and healthcare facilities)
• Assisting with device supply shortages

Labelling & Advertising

Review of Australian medical device labelling requirements, including product labelling, packaging, permitted indications, and consumer-facing advertising.

• Therapeutic Goods Advertising Code review
• Permitted indications matching
• Instructions for Use, product inserts and regulated patient information requirements
• Pre-publication review of marketing material, social media and health professional advertising

Quality System Implementation and Reviews

Quality management guidance and inspection readiness for sponsors, manufacturers, and contract sites performed by a qualified ISO 13485:2016 auditor.

• SOP development and review
• QMS Gap analysis
• Mock inspections and CAPA support
• Manufacturing site clearance applications
• Mergers and acquisition assistance