How Has the Pandemic Changed We Do Business? Everything has been affected since the Covid-19 pandemic hit the world. The virus has changed the way people do things in unprecedented ways. Today things such as stockpiling groceries, maintaining social distance, and refusing to shake hands are the new norm. Governments worldwide have devised strategies to…
The primary suppliers to the large medical device market in Italy are the United States, France, Germany, Belgium, and the Netherlands. High frequency medical lasers, home care equipment, remote monitoring equipment, anesthesiology equipment, stimulators, and defibrillators are in high demand. https://www.regdesk.co The four classes of medical devices must comply with International Standard of Organization(ISO) 13485:2016.…
Spanish Agency for Medicine and Health Products (AEMPS) regulates the quality, efficiency, and safety of medical devices(MD) in Spain. The agency regulates and certifies pharmaceuticals for humans and animals in addition to monitoring supplies and certifying medical devices. https://www.aemps.gob.es/ Spain has a population of over 47 million and the fourth largest economy in the European…
Registration of medical devices in Germany follows European Union (EU) regulations and the technical International Standard for Organization(ISO). Medical devices regulated by the Federal Institute for Drugs and Medical Devices (bfArM) are used for physical (not medicinal) purposes. Examples of these include implants, bandaging supplies, and dental devices. (https://www.regdesk.com) The five classes of medical devices…
The ANSM ensures all medical devices meet their standards for safety, efficiency, and quality. After a 3-year transition period plus a one year extension because of the effects of Covid-19. the MDR took effect in May 2020. EU Regulations 2017/745 and 2017/746 will be effective on the 26th of May 2021. In vitro regulations (IVRD)…
After considerable and often controversial negotiation between the UK and the EU, the Brexit free trade agreement became effective 31 Dec 2020. Free trade agreement terms include a number of significant provisions within the 1200 pages of this important document. MOVING FREIGHT Imports and exports will continue without tariffs or quotas. Beginning in January,…