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Singapore HSA’s GL-04 Revision 4 updates regulatory guidance for Software as a Medical Device (SaMD) and Machine Learning-enabled Medical Devices (MLMD). Key changes include expanded scope for ML functions, lifecycle governance, enhanced cybersecurity requirements, structured change management via CMP, and alignment with IMDRF/ISO standards. Manufacturers must strengthen lifecycle oversight, post-market monitoring, and ML model documentation to comply with the updated framework.

Malaysia’s Medical Device (Designated Medical Device) Order 2026 designates certain aesthetic devices—such as medical lasers, HIFU, and liposuction systems—as medical devices under Act 737. Effective 1 June 2026, these devices must comply with MDA registration and intended-use requirements. The Order clarifies regulatory obligations for manufacturers, importers, and clinics, reinforcing patient safety and regulatory oversight in Malaysia’s aesthetic medical sector.

Mexico’s General Health Law reform, published on 15 January 2026, updates Article 376 to allow medical device sanitary registration renewals for up to 10 years. Initial registrations remain valid for five years, but timely renewal requests and strict compliance are required to avoid cancellation by COFEPRIS. The change impacts long-term regulatory planning for medical device manufacturers in Mexico.

ANVISA’s 2025 manual clarifies how medical devices and Software as a Medical Device (SaMD) must be regularized in Brazil. It explains regulatory pathways, risk classification, documentation requirements, and registration or notification steps. By aligning with Brazil’s current regulatory framework, the guidance improves transparency and consistency for manufacturers, importers, and legal representatives seeking ANVISA market authorization.

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.