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Effective 29 October 2026, RS-01:2026(E) adds 12 AI standards and revises the Introduction. Manufacturers and LRPs should cite exact editions, assess the state of the art at checklist compilation, and identify evidence gaps beyond recognised standards.

The revised non-binding MDCG position paper plans manufacturer SSCP/SSP upload functionality for December 2026 and a 27 March 2027 upload target for devices placed on the market before mandatory use. Device registration and notified-body certificate milestones remain separate.

ANVISA's 22 October 2026 notice and updated standards page make three workbooks available — transversal v1.0 (60 entries), orthopedic implantable materials v1.1 (88 entries, adding 7 general ASTM standards over v1.0), and health-use materials v0.0 (62 rows covering 61 unique standards) — while maintaining voluntary recognition unless a sanitary regulation makes a standard compulsory.

On 22 October 2026, Czechia's SÚKL announced a temporary security shutdown of its electronic vigilance reporting interface following a NÚKIB PHP-vulnerability warning. Statutory reporting duties remain in force using the European Commission's MIR 7.3.1 (December 2025 SB-10781 or later, with May 2026 SB-11154 current) and FSCA forms, which SÚKL's vigilance instructions allow submitters to file as signed PDF and XML files via Data Box (qwfai2m) or email.

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.