What steps do Chinese medical devices need to enter Australia?

Author:Sonictec · 2026-09-11 Updated

Confirm the product and intended use first

Before Australian entry, check device status, intended use and classification rules. Descriptions, IFU, labels, models and use methods support the assessment. IVDs and other devices follow different rules; similar product names alone do not determine pathways.

Clarify manufacturer and Australian Sponsor roles

The Sponsor handles relevant Australian applications and ongoing responsibilities and needs arrangements for document access and manufacturer cooperation. Technical documentation, changes, complaints and adverse events should be covered in the engagement. Sponsor, distributor and logistics roles must also be clearly distinguished.

Review existing evidence and identify missing documents

Review technical files, clinical/performance evidence, labels, IFU, quality systems and overseas authorizations. Overseas certification does not automatically confer Australian access. Verify evidence usability and matching product scope under the applicable pathway.

Progress according to prerequisites and application sequence

Where manufacturer evidence is required, meet those requirements before submitting the applicable device application. Preliminary assessment, additional information or audits may be involved depending on the product and pathway. Sonictec can coordinate preparation, submission and regulatory correspondence.

Continue supply and maintenance arrangements after ARTG inclusion

Most medical devices require ARTG inclusion before lawful supply in Australia; applicable exemptions or exceptions need separate verification. Inclusion does not end project responsibilities. Ongoing arrangements should cover document updates, changes, complaints and adverse events.

Four types of information to prepare

Product and use, existing authorizations and technical documentation, manufacturer and current Australian arrangements, and target launch date. A summary is sufficient initially; detailed information can be exchanged under the agreed process.