International regulatory affairs may be quite burdensome - very often underestimated language barriers and/or cultural differences impede an efficient implementation.

Our worldwide network and competent local contact partners help to promote international activities in close coordination with national authorities.

• USA/FDA: 510(k) / PMA (PreMarket Aproval)
• Canada: CMDCAS certification
• Brazil: registration process harmonized with other member states of MERCOSUR
• Japan: revised Japanese PAL (Pharmaceutical Affairs Law)
• China: SFDA (State Drug Administration of China) registration and CCC (China Compulsory Certification)
• Taiwan: PAL registration
• Australia: TGA (Therapeutic Goods Act)
• Other European markets not covered by CE Marking, e.g. Russia