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regulations

EU Commission Publishes Updated “Blue Guide” on Product Rules

The Commission of the European Union (EU) has recently published an updated version of...

FCC Regulatory Process: Safety is Just One Consideration

Many people believe that the U.S. Federal Communications Commission (FCC) focuses primarily on public...

EU Commission Extends Transitional Provisions for In Vitro Diagnostics

The Commission of the European Union (EU) has amended key transitional provisions for certain...

EU Commission Modifies REACH Regulation on CMR Substances

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

FDA Publishes Principles for AI and ML in Medical Devices

Medical device regulatory agencies in the U.S., Canada, and the United Kingdom have recently...
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EU Market Surveillance Regulation Takes Effect

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

China Certification Authority CNCA Announces Important Changes to CCC Regulations

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.

The EU’s Medical Device Regulation (EU) 2017/745 – Are You Ready for Huge Sweeping Changes?

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.

New CCC Marking Regulations in China

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.

Electromagnetic Compliance: A View from the Field

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.
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