China – Chinese regulators recommend clinical evaluation paths for certain medical devices
China’s Center for Medical Device Evaluation (CMDE) published several new pieces of guidance that medical device manufacturers doing business in the country should review...
USA – FDA final rule reduces radiological devices reporting requirements
The US Food and Drug Administration (FDA) on Thursday issued a final rule that significantly reduces record-keeping requirements for medical devices such as x-rays....
International – Medical devices 2030 : Making a power play to avoid the commodity...
The days of simply manufacturing a device, and selling it to healthcare providers via distributors, have long vanished. Value is the new byword for...
USA – FDA finalizes guidance for containment system used with power morcellators
The US Food and Drug Administration (FDA) has finalized guidance that lists non-clinical testing information the agency wants from sponsors of tissue containment systems...
Europe – MDCG 2024-10 Clinical evaluation of orphan medical devices
The level of clinical evidence that is required to place medical devices on the market has been increased by the MDR, including an increased...
South Korea – South Korea rules on emergency production and distribution of medical products
Regulators in South Korea have introduced policies and procedures ordering the production and distribution of medical products during a public health emergency (PHE).
The Ministry...
USA – FDA proposes breakthrough status for devices that address health disparities
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has proposed that devices that aim to eliminate disparities in...
UK – UK regulator MHRA to raise medical device registration and other fees by...
The UK Medicines & Healthcare Products Regulatory Agency (MHRA) has published a consultation for industry comment regarding a proposed increase in fees the agency...
USA – Lasers: FDA publishes guidance on surveying, leveling and alignment products
The US Food and Drug Administration (FDA) has finalized a 2014 guidance that lays out its thinking what is and isn’t a regulated laser...
USA – FDA opens TAP
The US Food and Drug Administration (FDA) has initiated a soft launch of its Total Product Lifecycle Advisory Program (TAP), which was negotiated under...
