Market access process

A practical pathway from assessment to post-market support.

Ocevia structures Australian market access around early pathway clarity, evidence readiness, sponsor responsibilities, and long-term compliance.

Laboratory team reviewing diagnostic system data and records

Initial assessment

Review intended purpose, device type, classification, existing approvals, manufacturer evidence, and Australian supply goals.

Pathway planning

Define ARTG route, sponsor model, application risk, likely documentation gaps, and commercial launch dependencies.

Evidence preparation

Review technical, clinical, performance, labelling, QMS, and manufacturer evidence against Australian expectations.

Submission support

Prepare submission materials, manage application steps, and coordinate responses to TGA requests or audit questions.

Lifecycle compliance

Maintain records, manage changes, support adverse event reporting, and keep sponsor obligations active after inclusion.

Evidence readiness

Good submissions start before the application is filed.

Ocevia helps identify gaps early so manufacturers can avoid preventable delays, clarify responsibilities with distributors, and prepare records that can withstand TGA review.

Device classification Intended purpose Manufacturer evidence Technical file Clinical evidence Risk management Labelling and IFU Post-market plan

Pathway review

Want to know what your Australian pathway requires?

Request pathway review