Regulatory Affairs

Perform Regulatory Path Analysis.

Facilitate the Compliance of your Product to the Regulatory Requirements worldwide:

  • In Australia — TG Regulations

  • In EU — CE Mark, MDD93/42/EEC, IVD 98/79/EEC, AIMD 90/385/EEC, EU MDs Regulations

  • In the US — FDA QSR, 510(k), PMA

  • In Canada — CMDR/CMDCAS

  • In Singapore – HAS

  • In Japan — PMDA

  • In China — sFDA

  • Other Countries Regulations

 

Advise on & Help prepare documentation

  • Product Classification

  • Technical File preparation

  • Essential Requirements – TGA

  • Essential Principals – EU, Canada, others

  • Risk Management / Analysis - EN ISO 14971

  • Human factor engineering/ Usability Study - EN ISO 62366  

Regulatory services

  • CE Mark Application

  • UL and CSA Mark Applications

  • We can represent your company with the TGA and perform all required services from submissions to registrations and inclusion of your product on the ARTG.