# Connect and stay on top of the MedTech regulatory landscape globally. Pure Global is a trusted global leader and growth partner in the healthcare technology industry. Find regulatory insights from our expert team, AI-powered regulatory news tools, and ways to meet us at upcoming events. [Sign up to newsletter](https://www.pureglobal.com/resources/community#newsletter_highlight) Join Our Community ## What you get from signing up Subscribe to our MedTech newsletter for regulatory insights, early resource access, and practical updates that help you stay ahead. Regulatory Updates ### Be informed on regulatory changes Stay ahead of the curve with timely updates on the latest regulatory changes impacting the MedTech industry. Upcoming Events ### Find us at future MedTech events Explore our participation in key conferences, summits, and networking opportunities through our upcoming events list. Blog ### Get insights from industry experts Gain valuable perspectives from experienced MedTech professionals through our blog articles. News ## Regulatory News Explore regulatory updates and industry insights designed to help you take your product global. [View all](https://www.pureglobal.com/resources/regulatory-updates) Regulatory Update November 6, 2026 [EU MDCG 2026-6: Clinical Evidence Guidance for Orphan IVDs](https://www.pureglobal.com/news/eu-mdcg-2026-6-clinical-evidence-orphan-ivds) The EU published non-binding MDCG 2026-6 on 3 November 2026, explaining orphan IVD eligibility, justified clinical evidence limitations, post-market conditions, and voluntary expert-panel advice. [ Read full story ](https://www.pureglobal.com/news/eu-mdcg-2026-6-clinical-evidence-orphan-ivds) Regulatory Update November 6, 2026 [Thai FDA Class 2–4 Device Change Timelines and Fees](https://www.pureglobal.com/news/thailand-fda-class-2-4-change-notification-timelines-fees-2026) Thai FDA publicized Class 2–4 device change review conditions applicable from 21 October 2026. The matrix distinguishes reference-country-approved changes, topic bundles, expert review, and fees; two overlapping thresholds require confirmation. [ Read full story ](https://www.pureglobal.com/news/thailand-fda-class-2-4-change-notification-timelines-fees-2026) Regulatory Update November 6, 2026 [Türkiye TİTCK 2026/KKB-2: ÜTS E-Signature Document Uploads](https://www.pureglobal.com/news/turkey-titck-2026-kkb-2-uts-e-signature-upload-process) Türkiye’s TİTCK issued an importer secure e-signature option for ÜTS conformity documents on 2 November 2026, with per-importer authorization, three-business-day email verification, and specific upload and translation rules. [ Read full story ](https://www.pureglobal.com/news/turkey-titck-2026-kkb-2-uts-e-signature-upload-process) Regulatory Update November 1, 2026 [Hong Kong Revises MDACS Standards in RS-01:2026(E)](https://www.pureglobal.com/news/hong-kong-mdacs-rs-01-2026-recognised-standards) 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. [ Read full story ](https://www.pureglobal.com/news/hong-kong-mdacs-rs-01-2026-recognised-standards) News ## Company News Browse company milestones, strategic updates, and announcements from Pure Global. [View all](https://www.pureglobal.com/resources/news) Company News January 13, 2026 [Pure Global Introduces Flat Fee Pricing for Medical Device Market Access](https://www.pureglobal.com/news/pure-global-introduces-flat-fee-pricing-for-medical-device-market-access) 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. [ Read full story ](https://www.pureglobal.com/news/pure-global-introduces-flat-fee-pricing-for-medical-device-market-access) Company News November 6, 2025 [Pure Global Launches AI Builder](https://www.pureglobal.com/news/pure-global-launches-ai-builder-platform-to-cut-regulatory-submission-time-from-weeks-to-days) 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. [ Read full story ](https://www.pureglobal.com/news/pure-global-launches-ai-builder-platform-to-cut-regulatory-submission-time-from-weeks-to-days) Company News June 2, 2025 [Pure Global appoints Ran Chen as Chief Technology Officer](https://www.pureglobal.com/news/pure-global-appoints-ran-chen-as-chief-technology-officer) Pure Global's new CTO, Ran Chen, brings over a decade of experience in building and scaling machine learning products. [ Read full story ](https://www.pureglobal.com/news/pure-global-appoints-ran-chen-as-chief-technology-officer) Company News November 21, 2024 [Pure Global Joins International Trade Administration’s BSP Directory for China](https://www.pureglobal.com/news/pure-global-joins-international-trade-administrations-bsp-directory-for-china) Pure Global is proud to announce its inclusion in the China Business Service Providers (BSP) directory on the International Trade Administration website. [ Read full story ](https://www.pureglobal.com/news/pure-global-joins-international-trade-administrations-bsp-directory-for-china) Blog ## Recent Blog Posts Read articles, success stories, and regulatory insights from our global market access experts. [View all](https://www.pureglobal.com/resources/blog) [![Conceptual illustration of separate device classification and evidence decisions across four markets.](https://www.pureglobal.com/assets/generated/blog-covers/rsc_d8ejm4v079a4tbrdnkqrs6n0tx/en-553a2a821416459b.webp)](https://www.pureglobal.com/blog-posts/apac-eu-us-device-classification-clinical-pathway-divergence-japan-vietnam-mdr-2026) [ Deep Research ](https://www.pureglobal.com/resources/blog?tag=deep-research) ### [Device Classification and Clinical Evidence Across Four Markets in 2026](https://www.pureglobal.com/blog-posts/apac-eu-us-device-classification-clinical-pathway-divergence-japan-vietnam-mdr-2026) Assess device classification and clinical-data pathways across Japan, Vietnam, the US and EU, with dated registration and cost evidence. [ Read full story ](https://www.pureglobal.com/blog-posts/apac-eu-us-device-classification-clinical-pathway-divergence-japan-vietnam-mdr-2026) [![Conceptual illustration of a device change moving through separate local regulatory release decisions.](https://www.pureglobal.com/assets/generated/blog-covers/rsc_w0bpapxjpnjn6qn6hzt2hpnnp1/en-bcc5c5be978694ec.webp)](https://www.pureglobal.com/blog-posts/apac-latam-post-approval-device-change-control-singapore-malaysia-hongkong-mexico-2026) [ Deep Research ](https://www.pureglobal.com/resources/blog?tag=deep-research) ### [Device Change Control: A Five-Market Release Plan for 2026](https://www.pureglobal.com/blog-posts/apac-latam-post-approval-device-change-control-singapore-malaysia-hongkong-mexico-2026) Classify device changes in five markets, identify local release conditions, and separate annual representation fees from government charges. [ Read full story ](https://www.pureglobal.com/blog-posts/apac-latam-post-approval-device-change-control-singapore-malaysia-hongkong-mexico-2026) [![FDA 510(k) Pathway Selection: Evidence, Review Clocks and Costs in 2026](https://www.pureglobal.com/assets/generated/blog-covers/rsc_gch6xjx8rmdpssq2ckv5xnsmq5/en-b3937af3d17f1320.webp)](https://www.pureglobal.com/blog-posts/us-fda-510k-pathway-selection-3p510k-estar-review-clocks-2026) [ Deep Research ](https://www.pureglobal.com/resources/blog?tag=deep-research) ### [FDA 510(k) Pathway Selection: Evidence, Review Clocks and Costs in 2026](https://www.pureglobal.com/blog-posts/us-fda-510k-pathway-selection-3p510k-estar-review-clocks-2026) A data-backed guide to Traditional, Special, Abbreviated and third-party 510(k) decisions, with clear limits on what historical clearance times can predict. [ Read full story ](https://www.pureglobal.com/blog-posts/us-fda-510k-pathway-selection-3p510k-estar-review-clocks-2026) [![Team-NB MDR Documentation: Submission Completeness Checks (2026)](https://www.pureglobal.com/assets/generated/blog-covers/rsc_3tsgpnb6f5zdpfb4m7sazs3dzf/en-ab0a139680571b18.webp)](https://www.pureglobal.com/blog-posts/team-nb-mdr-technical-documentation-completeness-2026) [ Deep Research ](https://www.pureglobal.com/resources/blog?tag=deep-research) ### [Team-NB MDR Documentation: Submission Completeness Checks (2026)](https://www.pureglobal.com/blog-posts/team-nb-mdr-technical-documentation-completeness-2026) Interpret Team-NB’s notified-body completeness survey correctly and turn MDR technical-documentation guidance into a scoped evidence and submission check. [ Read full story ](https://www.pureglobal.com/blog-posts/team-nb-mdr-technical-documentation-completeness-2026) Events ## Events Meet the Pure Global team at upcoming events and discuss your regulatory and market access questions. [View all](https://www.pureglobal.com/resources/events) Trade Fair Düsseldorf, Germany Nov 16, 2026 ### MEDICA Trade Fair One of the largest medical B2B trade fairs globally, showcasing products and services across medical imaging, diagnostics, health IT, and more. [ Visit event page ](https://www.medica-tradefair.com/) Trade Fair Dubai, United Arab Emirates Jan 25 – 28, 2027 ### WHX Pure Global will attend WHX in 2027. [ Visit event page ](https://www.worldhealthexpo.com/events/healthcare/dubai/) Trade Fair Cologne, Germany Mar 16 – 20, 2027 ### IDS Pure Global will attend IDS in 2027. [ Visit event page ](https://www.ids-cologne.de/) [Canonical page](https://www.pureglobal.com/resources/community)