Canada Health Canada, the Canadian regulating authority, has published a notice to the medical devices manufacturers, dedicated to the technical requirements for decontamination devices employing ultraviolet (UV) radiation. The scope of the document covers both...
FDA The Food and Drug Administration (FDA) has published amended draft guidance on electromagnetic compatibility (EMC) of medical devices. The Agency encourages the industry representatives and other parties involved in operations with medical devices to provide their...
FDA The Food and Drug Administration (FDA) has published guidance on certificates of confidentiality. The document is intended to provide additional clarifications to study sponsors, investigators, researchers, and other industry representatives. All interested parties...
MDCG The Medical Device Coordination Group (MDCG), an advisory body of the European Commission focused on the improvement of the regulatory framework for medical devices, has published guidance on classification rules for in vitro diagnostic medical devices (IVDs). The...
FDA The Food And Drug Administration (FDA), the US regulating authority in the sphere of medical devices, has published guidance on micro-needling products. Notes The present document constitutes a final version of the draft guidance issued previously in September 2017....
Saudi Arabia The Saudi Food and Drug Authority (SFDA) has adopted an implementing rule regarding the requirements for Quality Management System (QMS) Auditing Organizations. The document is based on the Medical Devices Interim Regulation and is intended to clarify and specify the...
