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Time is running out for devicemakers to meet the May 26 deadline to renew or extend their device certificates under the new EU Medical Devices Regulation, MedTech Europe stressed in its latest status report. Read More
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The FDA released draft guidance for devicemakers on 510(k) submissions for catheter-based devices intended to treat peripheral vasculature lesions, including suggestions on labeling and performance testing. Read More
Health Canada has finalized guidance on software as a medical device (SaMD) that clarifies how it fits into the agency’s regulatory framework and how devicemakers can comply. Read More
The device for use by patients that cannot move independently and must stay in a prone or supine position, will continue to be seen as Class II, the agency said. Read More
Labeling should include information on indications, contraindications, warnings, product information and directions for use, the agency said. Read More
Devicemakers should ensure their devices are designed and manufactured such that the risks associated with “reasonably foreseeable environmental conditions” are removed or minimized. Read More
The committee met in 2019 to discuss how healthcare providers and the agency should communicate medical device cybersecurity risks to patients and the public. Read More
The FDA has released a new draft guidance that lays out a step-by-step process for applying data from a previously approved delivery system, a practice commonly known as bridging, to an application for a combination product. Read More