Medical Devices
Malaysia and China launch a regulatory reliance pilot to streamline IVD medical device registration and accelerate cross-border market access.
Key outcomes from China’s 2025 Two Sessions highlight regulatory updates, innovation policies, and new market opportunities for international medical device manufacturers.
NMPA’s draft guide defines medical device registration self-testing and self-checking for Class II and III devices under China’s QMS rules.
Latest NMPA drafts propose expanding Unique Device Identification (UDI) rules to nearly all medical devices by 2029.
Malaysia MDA's Draft 7th Edition labelling requirements introduce broader e-labelling requirements and stronger accessibility standards.
The Department of Health has mandated MDACS listing for public procurement eligibility — see which devices are affected and how to prepare.
China’s H1 medical device imports reached approx. USD 24 billion, showing stable demand amid shifts in key categories and sourcing countries.
Learn about the 104 products China’s NMPA admitted into the Special Review Procedure for Innovative Medical Devices in 2025.
China’s National Medical Products Administration has issued its 2026 medical device standards plan, introducing 80+ new and revised standards
NMPA solicites public opinions on the draft proposal to reclassify IVD reagents in the 6840 Classified Subdirectory (2013 Version).
On 20.12.2019, the China NMPA (National Medical Products Administration) announced (No.91-2019) that it would add 148 medical devices and 23 in-vitro diagnostic reagents to the clinical trial exemption list, as well as to revise the names and descriptions of 48 medical devices and 4 in-vitro diagnostic reagents. Medical devices and in-vitro diagnostic reagents on the clinical trial exemption list won’t require completion of clinical trials in order to achieve NMPA certification.This new clinical trial exemption list is effective since the date of announcement on 20th December.Feel free to contact us if you would like to know what products were included in the clinical trial exemption list for medical devices, and the clinical trial exemption list for IVDs.
A total number of 10579 applications and 9849 approvals for medical device registrations in China were reported in 2020 along with a detailed breakdown.
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