SMART quality & compliance
Medical Devices; US and Chinese legislation
US and Chinese legislation US legislation What is the framework of US Legislation? Figure 1: Framework of FDA Legislation. Adapted from FDA Legislation. Copyright 2020, Kvalito Consulting Group. How to classify a device under US regulation? How to classify a device under US regulation? In the USA, there are 1700 generic groups of devices classified within 16 medical specialties (21 CFR 862-892). The classification is based on a risk approach. Medical devices classified as Class I are considered as having the lower risk, Class II is considered a moderate risk and class III is the higher risk. How are the…
Read More >
SMART quality & compliance
What are the principal differences between the conformity assessment process of a medical device in the USA and in the European Union?
Figure 1: Comparison of European and US Conformity Assessment process of Medical Devices. Adapted from European law and United States law. Copyright 2020, Kvalito Consulting Group. The difference in the conformity assessment process between the European Union and the USA, is the need of a notified body in the European Union. The notified body is an organization designed by a member state to assess the conformity of products against the current European regulations and directives. The legal manufacturer of the medical device must contact a Notified Body (not necessarily from his own country) in order to obtain the CE mark…
Read More >
SMART quality & compliance
Bite-sized Knowledge: Medical Device Regulation
2A Regulation shall be applied in its integrality in all the European Union. Unless a Directive is an objective provided by the European Union, each country is free to develop its own measures to achieve this objective. Figure 1: Overview of the difference between Direction and Regulation. Adapted from European Law. Copyright 2020, Kvalito Consulting Group. Citizens and Companies implement their policy (act) according to their National law which is an interpretation of the European law. Citizens and companies implement their policy (act) according to European law. What are the changes in Medical Devices regulation? The European Parliament has…
Read More >