TGA regulatory strategy
Classification review, regulatory pathway assessment, evidence gap analysis, timeline planning, and risk-based market access advice.
Regulatory services
Services for TGA market access and lifecycle compliance.
Ocevia helps manufacturers understand the regulatory pathway, prepare evidence, manage ARTG inclusion, and maintain sponsor obligations after market entry.
ARTG inclusion support
Application preparation, manufacturer evidence review, TGA submission support, and response coordination for TGA queries or audits.
Australian sponsor services
Independent sponsor representation, TGA correspondence, ARTG entry management, records, and post-market obligations.
Technical documentation
Review of technical files, design documentation, risk management, IFU, labelling, clinical evidence, and Australian evidence gaps.
Clinical and performance evidence
Evidence readiness review, clinical evaluation support coordination, IVD performance evidence review, and gap summaries for submission planning.
QMS and audit readiness
ISO 13485 evidence review, supplier and distributor quality agreement support, audit readiness checks, and compliance process mapping.
Labelling and advertising review
Review of labels, packaging, instructions for use, website claims, promotional material, and Australian compliance considerations.
Post-market compliance
Adverse event reporting support, complaint and recall workflows, change control, annual maintenance, and post-market records.
Standards and evidence
We help translate global evidence into an Australian pathway.
Manufacturers often already hold evidence from EU MDR, FDA, UKCA, Health Canada, MDSAP, or ISO programs. Ocevia helps identify what can support the Australian submission and what may need additional review.
ISO 13485
ISO 14971
EU MDR / IVDR
FDA 510(k) / De Novo
MDSAP
Clinical evidence
Performance evidence
Post-market data
Next step