EU MDR/IVDR
The Medicines and Healthcare products Regulatory Agency (MHRA) has published detailed guidance dedicated to the new regulations that will take effect from January 1, 2021. Starting from the aforementioned date, the authority would be fully responsible for all...
EU MDR/IVDR
The Medical Devices Coordination Group (MDCG) has published special guidance providing medical device manufacturers and other parties involved with additional recommendations and clarifications regarding how Article 15 of the Medical Device Regulation 2017/745 (MDR)...
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission, has issued the first revision of guidance notes to the manufacturers of Class I medical devices initially published in December 2019. In particular, the document intends to...
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...
COVID-19
The LÆGEMIDDELSTYRELSEN, the Danish Medicines Agency, published guidance describing the extraordinary measures for clinical trials in the context of the outbreak of the Coronavirus Disease 2019 (COVID-19). COVID-related Regulatory Background The Danish Medicines...
