Asia-Pacific

TFDA regulates medical devices in Taiwan under the Medical Devices Act. Taiwan’s classification system follows a risk-based approach similar to […]

Thai FDA regulates medical devices in Thailand. Devices are classified as general, controlled, or specially controlled medical devices.

Medsafe regulates medical devices in New Zealand. New Zealand has close regulatory alignment with Australia’s TGA through the Trans-Tasman mutual

HSA regulates medical devices in Singapore under the Health Products Act. Singapore’s regulatory framework is risk-based and aligned with IMDRF

MDA regulates medical devices in Malaysia under the Medical Device Act 2012. It manages device registration, establishment licensing, and post-market

MFDS regulates medical devices in South Korea under the Medical Devices Act. It operates the Korean Good Manufacturing Practice (KGMP)

TGA regulates medical devices in Australia through the Australian Register of Therapeutic Goods (ARTG). It participates in MDSAP and recognizes

PMDA regulates medical devices in Japan under the PMD Act. It conducts premarket reviews (Shonin approval), GMP inspections, and post-market

NMPA (formerly CFDA) is China’s regulatory authority for medical devices. Device registration requires clinical trials for Class II and III