Asia
The article provides a brief overview of Pakistan’s regulatory requirements in the sphere of importation and exportation of medical devices and highlights the key points to be considered by medical device manufacturers and other parties involved in placing medical...
Ethiopia
The new article provides additional details regarding the documents to be included in the submission dossier and also highlights some important aspects related to the procedures to be followed when applying for marketing approval. The general principles and...
Ethiopia
The new article provides an in-depth review of existing application submission pathways an interested party may follow when placing its product on the market. In particular, the present article describes the general principles and requirements to be considered when...
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...
Asia
The first article provides an overview of the general provisions of a new draft regulation on clinical trials for medical devices. Table of Contents The Turkish regulating authority has published a draft regulation on clinical trials for medical devices....
Ethiopia
The new article provides additional details regarding the documents required when importing medical devices in Ethiopia, as well as the information these documents should contain. Additionally, the article describes the procedures to be followed when importing medical...
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