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Malaysia MDA’s 2026 revised labelling guidelines introduce e-labelling for home-use medical devices, allowing electronic delivery of instructions and safety information. E-labelling must include all required label content, be accessible via URL or QR code, and undergo a risk assessment to ensure safety. Printed labels may still be required for critical information. This update improves accessibility, reduces printing costs, and reflects Malaysia’s commitment to modern, patient-friendly medical device regulation.

Malaysia’s 2026 MDA–HSA Regulatory Reliance update formally recognizes Singapore’s HSA as a reference authority after a six-month pilot. Devices registered with HSA may qualify for conformity assessment in Malaysia via verification, benefiting from lower CAB fees and shorter review timelines. The programme strengthens ASEAN regulatory convergence and supports faster Malaysia medical device registration while maintaining compliance and safety standards.

Brazil’s 2026 Anvisa–MFDS Cosmetics MoU strengthens regulatory cooperation between Brazil and South Korea. The agreement focuses on cosmetics regulation, safety assessment, post-market surveillance, and regulatory alignment. By enhancing technical exchange and harmonization efforts, the partnership supports smoother market access and stronger public health oversight. The MoU updates a 2014 agreement and reflects growing global convergence in cosmetics regulatory frameworks.

Indonesia Perpres 6/2023 requires Halal certification for drugs, biological products, and medical devices containing animal-derived materials. BPJPH issues the certificates, while foreign Halal certificates from bodies with an MRA are accepted after registration. Phased compliance is based on risk class: Class A by 2026, B by 2029, C by 2034, and D/biological products by 2039. Non-animal-based devices are exempt unless containing prohibited ingredients, which must be clearly labeled as non-Halal.

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.