On June 1, 2014, China’s new “Regulations on the Supervision and Administration of Medical Devices” went into effect.
New regulations are intended to establish a more efficient and scientific regulatory regime for supervision and administration of Medical Devices. Generally, the New Regulation moderates the oversight of low-risk Medical Devices and strengthens the supervision on high-risk devices.
Among other things, the New Regulation enhances post-marketing supervision by enacting provisions to establish mechanisms for adverse event monitoring, re-evaluating registered products and product recalls. Such provisions aim to effectively identify problematic Medical Devices in the market and provide statutory remedies to stop the manufacturing, sales, distribution and use of unsafe Medical Devices in the market.