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

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.

DRAP's 16 October 2026 letter (posted 17 October 2026) directs medical-device importers to submit import clearance applications through the Pakistan Single Window (PSW) system, restricts the Online Import & Export System (OIES) during the transitional phase to applicants blocked by data-updating issues, and instructs all importers to complete establishment licence and device registration data updates in DRAP's system.

TMDA's 2027 annual retention notice sets a 1 November 2026 continued-marketing declaration deadline, a 31 January 2027 fee deadline (USD 200 per registered imported medical device or IVD and USD 50 per notified imported device or IVD under GN No. 686 of 2021), a 15% late-payment penalty window from 1 February to 31 March 2027, and registration suspension plus import-permit blocks from 1 April 2027.

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.