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Brazilian Regulators Update Economic Monitoring Requirements for Some Medical Devices
Brazilian medical device regulator ANVISA has issued new regulations regarding economic monitoring of certain device types in order to boost transparency and establish reference pricing for these products.
Guidelines Released for Transition in Philippines to ASEAN Harmonized Requirements
The Food and Drug Administration (FDA) of the Philippines published Circular No. 2021-002, providing for further implementation of the Association of Southeast Asian Nations (ASEAN) regulatory framework for medical devices.
UK MHRA Provides Registration Requirements for IVDs Undergoing Performance Evaluation
The United Kingdom's medicines and healthcare products regulatory agency, (MHRA) updated its medical device and IVD registration guidance to include a section on IVDs undergoing performance evaluation.