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Medical devices - BASG
- https://www.basg.gv.at/en/medical-devices/
- Medical devices may only be placed on the Union market if the requirements of the respective European regulation (MDR, IVDR) are met. These include, among other …
Home - BASG
- https://www.basg.gv.at/en/
- This is the subpage with information by the BASG directed to companies producing, controlling or distributing medicinal products or medical devices. read more Market …
About us - BASG
- https://www.basg.gv.at/en/about-us/
- BASG - Federal Office for Safety in Health Care / AGES MEA - Austrian Medicines and Medical Devices Agency. As of January 2, 2006, the BASG commenced …
Medical Devices and Pharmaceutical Products: GDP and …
- https://www.qualityaustria.com/en/product-groups/medical-devices/medical-devices-and-pharmaceutical-products-gdp-and-gmp/
- Medical Devices and Pharmaceutical Products: GDP and GMP. Overview. Good Manufacturing Practice (GMP) is part of quality assurance system for manufacturing …
Austrian Medicinal Product Index - BASG
- https://www.basg.gv.at/en/companies/marketing-authorisation-life-cycle/faq-marketing-authorisation-life-cycle/austrian-medicinal-product-index
- Ordinance of the Federal Minister of Health on the Austrian Medicinal Product Index 2013. The details of all medicinal products authorised in Austria can be retrieved …
Austria - Medical Devices - International Trade …
- https://www.trade.gov/country-commercial-guides/austria-medical-devices
- Market Drivers and Constraints: Austria’s medical device market is driven by three main factors: 1) an aging population and the accompanying increasing burden of …
Medical devices - BASG
- https://www.basg.gv.at/en/market-surveillance/official-announcements/medical-devices
- The Federal Office for Safety in Health Care (BASG) has been informed that "LOGIMED Medizinische Spezialprodukte Gesellschaft m.b.H., Gösserstraße 11, 8700 Leoben" …
Medical Devices - Quality Austria
- https://www.qualityaustria.com/en/product-groups/medical-devices/
- The devices range from sterile to non-sterile medical devices, invasive to non-invasive medical devices as well as non-active medical devices to active implants. >> Read on …
National competent authorities (human) | European …
- https://www.ema.europa.eu/en/partners-networks/eu-partners/eu-member-states/national-competent-authorities-human
- The European Medicines Agency works closely with the national competent authorities of the Member States of the European Union (EU) and the European …
Medical Devices; Current Good Manufacturing Practice …
- https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices/medical-devices-current-good-manufacturing-practice-cgmp-final-rule-quality-system-regulation
- The FDA is revising the current good manufacturing practice (CGMP) requirements for medical devices and incorporating them into a quality system regulation.
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