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Malaysia’s Medical Device Authority (MDA) has published the first edition of MDA/GD/0072 Change Management for Registered Medical Devices, which will replace MDA/GD/0020 following the official launch of MedCAST 3.0. Until implementation takes effect, the current change notification guidance remains applicable. Companies should review the new guidance and prepare for upcoming regulatory process changes.

Malaysia’s MDA updated the Requirements for Labelling of Medical Devices in 2026 by revising Clause 4.8(e) for foreign manufacturers. Under the new requirement, manufacturer name and address remain mandatory, while contact details such as email, phone number, or website address for technical assistance are now optional. The update provides greater flexibility for medical device labelling compliance in Malaysia.

Singapore and China have renewed their health products regulatory partnership, expanding collaboration into cutting-edge therapies including cell, tissue, and gene therapy products. The updated MOU between Singapore's HSA and China's NMPA aims to streamline regulatory pathways and accelerate patient access to innovative treatments across both countries. For healthcare companies and researchers, the strengthened agreement could unlock new cross-border opportunities in one of the world's fastest-growing life sciences markets.

The CMS and FDA RAPID Coverage Pathway 2026 accelerates Medicare access to breakthrough medical devices by aligning regulatory approval and coverage decisions. It enables early CMS–FDA collaboration, shared clinical evidence, and same-day proposed coverage decisions upon FDA authorization. Eligible devices include certain Class II and Class III breakthrough devices studied in Medicare populations, reducing coverage timelines from over a year to approximately two months.

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.