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Argentina's Disposición ANMAT Nº 5461/2026 adds an ARS 5,000,000 ceiling to the 1.25% medical-product import-intervention fee from 1 September 2026. The ARS 55,000,000 tier threshold, both percentage rates, and the fixed device and IVD fees in Anexo II are numerically unchanged from the May 2026 schedule.

The Medical Devices (Third Amendment) Rules, 2026 add “or European Union countries” to Rule 63(1) proviso (iv) for devices without a predicate. The two-year marketing, CLA, and post-marketing-investigation conditions are unchanged. Class A NSNM manufacturers and importers must now self-certify compliance with the Quality Management System as well as standards specified in the rules.

The Medical Devices (Second Amendment) Rules, 2026 add Rule 44(p): when sterilisation is outsourced to another licensed facility, that site’s licence number must appear on the device label. Compliance is mandatory six months from 14 August 2026 (14 February 2027). A Ninth Schedule of test fees applies from gazette publication.

Dated 28 July 2026, FDA Advisory No. 2026-1007 clarifies that a medical-device CPR remains valid after its expiry date if renewal was filed within 120 days of original expiry and applicable fees were paid, but only until FDA decides the application. It does not amend the IRR of RA 9711.

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.