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...
Europe
The Bosnia and Herzegovina Agency for Medicines and Medical Devices, the country’s regulating authority in the sphere of healthcare products, has published a user guide dedicated to the national information system for medical devices. The present article describes the...
Europe
The Bosnia and Herzegovina Agency for Medicines and Medical Devices, the country’s regulating authority in the sphere of healthcare products, has published a user guide dedicated to the national information system for medical devices. General Information About...
