Asia
The Medical Device Authority (MDA), a branch of the Ministry of Health Malaysia responsible for medical device regulation, issued guidance documents dedicated to handling complaints, and mandatory problem reporting. Regulatory Background The Malaysian regulating...
FDA
The Food and Drug Administration (FDA) issued select updates for guidance relating to animal studies for the non-clinical and clinical investigation of medical devices used for the treatment of benign prostatic hyperplasia (BHP). Regulatory Background and Scope of the...
Poland
The Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products (URPL), the Polish regulating authority in the sphere of medical devices, published a detailed overview of the current regulatory framework in order to assist medical device...
FDA
The Saudi Food and Drug Administration (SFDA) issued updated guidance requirements for medical device listing and marketing authorization. The document is intended to provide medical device manufacturers, their authorized representatives, distributors, and other...
FDA
The European Commission issued a Question and Answer document in order to provide medical device manufacturers with the information regarding the way the new Manufacturer Incident Report (MIR) Form shall be implemented. New Manufacturer Incident Report Form in Brief...
FDA
The Food and Drug Administration (FDA), the US authority responsible for medical devices regulation, issued guidance on supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) submissions in the context of the outbreak of the...
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