Regulatory and quality documents

CLS(MD) Level 1

Cybersecurity label

Published CLS(MD) Level 1 label for aiTriage v1, reference CSA/MDX00001. The scheme link explains the label requirements.

Singapore: Class C registration

The Singapore Medical Device Register lists aiTriage v1 (DE0507506) as a Class C medical device, registered on 18 November 2022.

ISO 13485:2016

Quality management system certificates

BSI certificates MD 722215 (UKAS accreditation) and MD 814895 (SAC accreditation, issued by BSI Singapore) cover the design, development, manufacture and distribution of triage risk stratification software, plus the import, storage, distribution, installation and servicing of patient monitoring and electrocardiograph devices. MD 814895 also covers general active medical devices and monitoring devices. Both are effective from 5 April 2026 to 4 April 2029.

Document date: April 5, 2026

Expiry shown: April 4, 2029

Malaysia: Class C registration

The MDA certificate records aiTriage v1 as a Class C medical device, registration GC8288223-137875.

Document date: June 28, 2023

Expiry shown: June 27, 2028

Vietnam: Class B declaration

The Hanoi Department of Health document records a Class B declaration for aiTriage v1, number 230002997/PCBB-HN.

Document date: November 15, 2023