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Taiwan’s legislature passed the Medical Device Management Law, which separates the country’s regulation of medical devices from pharmaceutical products for the first time. Read More
China’s National Medical Products Administration (NMPA) updated its clinical trial regulations for medical devices last month, designating eight device categories that require clinical trials. It also added new exemptions from clinical trial requirements, allowed conditional approval with limited clinical data and published guidelines on the use of real-world data (RWD). Read More
The FDA slapped Henan Kangdi Medical Devices with a warning letter over repeat CGMP failures at its Zhoukou, Henan facility, including a lack of testing.
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The Federal Court of Australia has found Johnson & Johnson responsible in a lawsuit by more than 1,350 women over injuries linked to failures of its pelvic mesh. Read More
South Korea has updated its medical device regulations to provide a pathway for innovative technologies such as artificial intelligence, robotics and 3D printing technology applied to medical devices. Read More
China’s State Council unveiled a plan to drive down high prices for medical devices and substitute expensive imports with locally made products. Read More
At the recent International Medical Device Regulators Forum (IMDRF) meeting in Moscow, Japanese and South Korean regulators said they plan to introduce mechanisms to allow for rapid access to needed devices and in vitro diagnostics. Read More
Australia’s Therapeutic Goods Administration has implemented new recall procedures that clarify when to quarantine products as well as how to communicate information about recalls. Read More
China’s Copious International fell short on submitting medical device reports and tracking complaints, as well as validation procedures, a Feb. 5 to Feb. 8 inspection of the firm’s Guang Dong, China facility revealed. Read More
China’s State Drug Administration is implementing a new device review procedure to bring innovative devices to market faster and to encourage more innovation in China’s supply chain. Read More
Procedures for submitting medical device reports to the FDA, as well as inadequate CAPA procedures were among the numerous quality system failures uncovered during a Jan. 29 to Feb. 1 inspection of Beijing Polycon Medical Engineering’s plant in Beijing. Read More