Asia
The article provides an overview of the regulatory requirements related to recalls and withdrawals for general and in vitro diagnostic medical devices allowed to be marketed and used in Turkey. Table of Contents The Turkish regulatory agency in the...
FDA
The article provides an overview of the regulatory requirements for medical devices used to improve glycemic control. The document constitutes a draft guidance the authority has published in order to collect feedback from industry representatives and other parties...
Asia
The second article provides additional details regarding the responsibilities of the parties involved in clinical trials and the most important aspects associated thereto. Table of Contents Turkey has published a new regulation on clinical trials...
Kazakhstan
Kazakhstan has recently adopted new rules on clinical trials for medicines and medical devices, including clinical and laboratory examination of in vitro diagnostic medical devices. The new Order of the Minister of Healthcare of the Republic of Kazakhstan dated...
Uncategorized
The International Medical Device Regulators Forum (IMDRF) has released guidelines on clinical evaluations, clinical investigations, and clinical evidence for medical devices. These documents replaced the previous documents that regulated the same areas as issued by...
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