regulations

The Commission of the European Union (EU) has amended portions of its regulation on...

Medical device regulatory agencies in the U.S., Canada, and the United Kingdom have recently...

A landmark piece of European Union (EU) legislation intended to strengthen market surveillance of...

The latest announcement by Chinese Certification Authority CNCA has a significant impact on many automotive suppliers and car manufacturers. Several products were removed from the list of products that require compulsory product certification. Other products must now obtain a CCC Self-Declaration.

This article discusses the history of why the EU MDR came into existence. It goes into the critical dates to be aware of, many of the significant changes, and impacts on many of the players (Notified Bodies, manufacturers, etc.). Lastly, it details the key steps that device manufacturers should take to implement the provisions of the MDR.

China is the second biggest economy in the world. The strong economic growth of the last decades has lead the country to develop its own quality standardization system. The China Compulsory Certification (CCC) is a system which is comparable, but not identical in terms of standards and requirements to the EU’s CE mark or the FCC’s declaration of conformity in the U.S.

This article will look at what causes harmful interference and how EMC regulations address them. It will examine three typical and largely encompassing cases that can be extrapolated to many other applications.

The U.S. Federal Communications Commission (FCC) has finalized its regulations covering personal radio services,...

The U.S. Food and Drug Administration (FDA) has identified an extensive list of Class...

Transported lithium-based batteries are divided into two types: lithium-ion found in mobile phones and laptops, and non-rechargeable lithium-metal used in medical devices and a number of consumer grade AA, AAA and 9V batteries.