We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA has accredited 68 testing laboratories so far under its Accreditation Scheme for Conformity Assessment (ASCA) pilot, in which testing labs may be accredited by accreditation bodies to assess the conformance of a device with certain FDA-recognized standards. Read More
The European Commission’s Medical Device Coordination Group (MDCG) issued guidance that clarifies when certifications for high-risk Class D in vitro diagnostics would need to involve an expert review panel. Read More
The FDA has issued a warning letter to a Chinese devicemaker, Tianjin Bolang Science-Technology Development, listing nine violations for ear, nose and throat (ENT) devices exported to the U.S. Read More
The Philippines FDA is advising devicemakers on documents needed as the agency transitions to new harmonized technical requirements as part of the Association of Southeast Asian Nations (ASEAN). Read More
The EU’s Medical Device Coordination Group (MDCG) released guidance on evaluating the performance of in vitro diagnostics that detect SARS-CoV-2 nucleic acid, antigens and that quantify antibodies. Read More
The International Coalition of Medicines Regulatory Authorities (ICMRA) urged regulators to consider taking a risk-based approach to the use of artificial intelligence (AI) in the pharmaceutical industry in a new report. Read More
Australia’s Therapeutic Goods Administration (TGA) is requiring manufacturers of permanently implantable devices to provide patient implant cards and consumer device leaflets with their devices. Read More
Health Canada issued a notice explaining how it classifies ultraviolet (UV) light-emitting decontamination products making COVID-19 claims and the pathways for market authorization. Read More
Reports of a vulnerability in the Blackberry operating system used in certain medical devices and device manufacturing equipment as well in pharmaceutical manufacturing equipment has prompted the FDA to issue a cybersecurity alert. Read More
Remote audits are turning up roughly the same number of non-conformities as seen in onsite audits, a majority of EU notified bodies said in response to a survey. Read More
Australia’s Therapeutic Goods Administration (TGA) has released updated guidance on new regulations for software-based medical devices that became effective in February 2021. Read More
Australia’s Therapeutic Good Administration has begun a postmarket review of all continuous and non-continuous ventilators, acute care ventilators, ambulatory ventilators including positive airway pressure (CPAP) devices and bi-level positive airway pressure (BiPAP) devices on the Australian Register of Therapeutic Goods (ARTG). Read More
