Regulatory Consulting

AcmeBiotechs Consulting Co. is a regulatory consulting firm serving the medical device and IVD industries. We offer professional consulting to assist our clients with regulatory issues on their way to entering new foreign countries.It is especially important for medical device firms to comply with regulations in different countries in order to access those markets. Regional regulations have varied requirements on labeling, device registration, premarket notification, and other approvals. We help our clients complete and submit these complex and significant files and assist them through any administrative processes. Shown below are links to basic information about regulations in different countries.
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United States
  • Premarket Notification, 510(k)
  • Establishment Registration and Device Listing
  • Investigational Device Exemption, IDE
  • Premarket Approval, PMA
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Taiwan
  • Device Registration   
  • Quality System Documents (QSD)
  • Taiwan Product License Holder
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Europe
  • CE Marking Certification
  • MDR Technical Construction File
  • Risk Management Report
  • Clinical Evaluation
  • European Authorized Representative
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China
  • Device Registration
  • In-Country Representation
  • CFDA Approval