Regulatory Information

Publication policy

Regent does not state or imply that any device is TGA approved, included in the Australian Register of Therapeutic Goods, registered with the TGA, clinically proven, FDA approved, medically approved or guaranteed safe unless written documentation supporting that exact device, manufacturer and configuration has been supplied and verified.

Where an ARTG inclusion is verified, Regent publishes factual wording in the form: "Included in the Australian Register of Therapeutic Goods — ARTG [number]".

Recorded fields

For each platform, Regent maintains an Australian Regulatory Status record covering ARTG status, ARTG number, Australian sponsor, intended purpose, device classification, approved indications, evidence document and verification date. These fields remain unpublished until the regulatory claim is marked as verified.

Certification records

Certification documentation — including CE, MDR, ISO 13485, IEC/EN testing, electrical safety, EMC testing and ARTG inclusion — is recorded with certificate number, issuing body, manufacturer, covered model, issue date, expiry date and verification status. Only verified certifications are displayed publicly.

Current status

• Regent R7 Diode — No verified regulatory claim published.
• Regent R5 Q-Switched — No verified regulatory claim published.
• Regent R4 Thulium — No verified regulatory claim published.
• Regent R3 CO₂ — No verified regulatory claim published.