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....
China
Under the general rule, combination products constitute a specific group of products consisting of both medicine (drug) and medical device. In such a case, both products (medicine drug and medical device) are supplied together and intended to be used together for a...
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for medical devices, has published and questions-and-answers document dedicated to repacking and relabeling activities by the Medical Devices Regulation 2017/745...
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission in the sphere of medical devices, has published a guidance document dedicated to the current classification rules. The document is intended to assist medical device manufacturers...
EU MDR/IVDR
The European Medicines Agency (EMA) has published guidelines dedicated to the quality documentation to be provided for medicinal products intended for use with medical devices. The present article addresses matters related to medicinal products with co-packaged or...
EU MDR/IVDR
The European Medicines Agency (EMA) has published a guidance document dedicated to the quality documentation for medicinal products when used with a medical device. The present document constitutes a final version which will enter into force on January 1, 2022. Table...
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