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Brazil's ANVISA and the Hong Kong Department of Health signed a five-year Memorandum of Understanding on 23 September 2026 for cooperation and information exchange, including on medical devices. The MoU is expressly non-binding and does not change device registration in Brazil or listing in Hong Kong.

Indonesia's Minister of Health issued KMK 951/2026 on 7 September 2026, a marketing authorization guideline for software as a medical device, software in a medical device and AI-enabled devices. It sets AI/ML dossier content, local clinical validation for certain imported software, a new-authorization rule for changes affecting indication for use, main function or clinical performance, and annual routine inspections.

In a 17 September 2026 press release, Singapore's HSA reported MOUs with the Saudi Food and Drug Authority and the African Medicines Agency, a Malaysian NPRA pilot referencing HSA's medicine assessments, continued work with the UK MHRA and its IMDRF chair deliverables. The release announces no change to device registration requirements and no reliance route open to device manufacturers.

On 25 September 2026 WHO launched medical device prequalification assessments. Condom and IUD prequalification moves from UNFPA to WHO, CAD-TB screening software becomes eligible, and WHO may remove UNFPA-prequalified contraceptives from its acknowledgment list if their manufacturers have not applied by 30 September 2028.

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.