REGULATORY NEWS

August 30, 2019

The European Union is stepping up efforts to ensure that only products that are safe and compliant with EU legislation can be placed on the market. 

On June 25, 2019, the Regulation (EU) 2019/1020 on Market Surveillance and Compliance of Products and amending Direc...

July 18, 2019

On May 8, 2019, the US Food and Drug Administration (FDA) has issued two final guidance documents regarding X-ray devices designed to more closely align FDA requirements with internationally developed standards:

  • The Guidance “Policy Clarification for Certain Fluoros...

July 16, 2019

To comply with the ASEAN Medical Device Directive (AMDD), the Philippines issued new "Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements". The document governs the notification or registration...

June 27, 2019

The US Food and Drug Administration (FDA) determined the list of accessories suitable for Class I Medical Devices. This classification came into force on May 13, 2019. The Classification was carried out according to the risks of the accessory's intended application and...

May 27, 2019

In November 2017, the EAEU Council approved requirements for implementation, maintenance, and evaluation of the quality management system for medical devices with regards to the potential risk of their use. These measures were implemented to ensure that products sold i...

February 8, 2018

The first step to place medical products on the Russian market, is to go through State registration of medical products.

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