The Most Relevant and Impactful Medical Device Regulations in China

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In China, the National Medical Products Administration (NMPA) – previously the China Food and Drug Administration (CFDA) is responsible for pharmaceuticals and medical device regulations. Similar to the United States, medical devices are classified into three classes (from I to III), which are based on potential risk. When placing medical device products onto the Chinese marketplace, a number of things must be taken into consideration.

An Overview of Electronic Product Regulations in the United States

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Placing products on the United States marketplace can be rather complicated when it comes to safety and compliance. In relation to electronic products, some aspects are covered by regulations and mandatory standards, while other aspects – including electrical safety – are covered by what is known as ‘voluntary’ safety standards. If you are a company wishing to sell products in the United States, this overview may be useful to refer to.

New Regulation For the Machinery Directive in Europe

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The Machinery Directive (also known as Directive (EU) 2006/42/EC) exists to establish a regulatory framework for placing machinery on the Single Market of the European Union. During the ‘REFIT’ evaluation of the Directive, stakeholders confirmed that this legislation, while important, contains a necessity to improve and adapt to the needs of the market. The revision was listed in the European Commission’s 2020 Work Programme.

CE Marking in the World of Robotics

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Robotics is a complex topic that requires the finest attention to detail in terms of ensuring compliance standards are met in any market. The European Commission has developed standards specifically relating to different types of robots, and it is important that manufacturers ensure they are meeting the correct standards for the type of robot they wish to put onto the market. We have simplified some of the information for you in this article.