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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
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 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 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 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
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
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 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
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