Innovations in medical devices have increased manifold in recent years. This acceleration can be especially attributed to the vast development in cloud computing and the Internet of Things (IoT). Similarly, Software as a Medical Device (SaMD) has seen an increase in demand and remains a major contributor to the overall growth of the device industry.
The 510(k)-clearance program, also known as Pre-Market Notification (PMN), is US FDA’s device review pathway to ensure safe and effective entry of medical devices into the US territory. US FDA requires manufacturers of the majority of Class II devices and a few Class I and III devices to obtain 510(k)-clearance.
The emergence of digital health technologies has fast-tracked the evolution of the healthcare sector. New-age healthcare products like wearables, telemedicine, and clinical decision-making tools use Artificial Intelligence (AI) and Machine Learning (ML) algorithms. Global Health Agencies, including CDSCO, are gearing up and devising new regulations to address the transformation.
There are various Economic Operators (EOs) who play a vital role in a device supply chain while delivering them to the point of use. Given the importance of each role, the Swiss Medical Device Ordinance (MedDO; SR 812.213) has set out the roles and responsibilities for each of these EOs. The three (03) major economic operators (EOs) in the supply chain are the Swiss Authorized Representative (Swiss AR/CH-Rep), importers, and distributors.
