Connect and stay on top of the MedTech regulatory landscape globally.

Singapore plans more integrated health regulation. Device manufacturers should distinguish AI oversight coordination from the ACE–HSA Priority Track’s current drug and CTGTP scope.

On 16 October 2026, Australia's TGA published its digital scribe targeted review outcomes and updated guidance. Although none of the 12 reviewed suppliers identified their product as a medical device, TGA found 8 of 12 included likely medical device functions.

On 6 October 2026, the US FDA published a Final Order (91 FR 63478) amending 14 Class II clinical toxicology regulations in 21 CFR Part 862 to expand 510(k) exemptions to devices intended for Federal drug testing programs, subject to labeling and 21 CFR 862.9 limits.

Taiwan designated mdctp.fda.gov.tw for GCP Article 7 registry updates from 1 October 2026. Revised application guidelines effective 5 October reflect electronic submission already in use and update the forms, file formats and reporting dossiers.

Pure Global has launched a flat-fee pricing model for medical device registration that simplifies global expansion across 13 key markets. With AI-assisted dossier preparation and in-country representation included, manufacturers can easily plan their market access budgets.

Pure Global has launched AI Builder, a proprietary automation platform that cuts medical device dossier preparation time by up to 75%. The launch introduces a new flat annual pricing model and marks a major step toward on-demand, AI-powered global medical device registration.

Pure Global's new CTO, Ran Chen, brings over a decade of experience in building and scaling machine learning products.

Pure Global is proud to announce its inclusion in the China Business Service Providers (BSP) directory on the International Trade Administration website.