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

INVIMA's Specialized Chamber says watches, bracelets, bands, rings, and similar wearables are medical devices when intended for diagnosis or clinical monitoring, but not when limited to wellness without medical claims. In-scope products generally fall under Rule 10 as Class IIa, or Class IIb when specifically intended to monitor vital parameters whose variation may present an immediate danger to life.

ANVISA’s IVD regularization manual (GEVIT, RDC 830/2023) and class I/II materials-notification manual (GEMAT, RDC 751/2022) are orientation texts. Missing documents mean summary refusal. Notification under this class I/II materials route does not require technical analysis for regularization but remains subject to review and audit.

From 1 September 2026, Czech free-sale certificate (FSC) applications go only through ISZP. RZPRO FSC filing ends 31 August 2026. The device must be in EUDAMED status Registered. The fee is 1,000 CZK. RZPRO records are not transferred.

The Digital Omnibus on AI is in force. High-risk rules in Chapter III, Sections 1 to 3, apply from 2 December 2027 for Annex III systems and from 2 August 2028 for Annex I systems, including medical devices and IVDs that meet Article 6(1). Article 50's general application date was not postponed; a separate transition applies to specified Article 50(2) marking.

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.