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Industry Sector News

CANADA NEWS

  • Orion Registrars Cessation as CMDCAS Recognised Registrar by Health Canada
  • Health Canada Issues Private Label Medical Device Guidance and Forms

CLINICAL STUDIES NEWS

  • FDA Revises Computerized Clinical Trial Systems Guidance
  • FDA Issues Guidance for Orthopedic Device Clinical Data

MEDICAL DEVICE NEWS

  • FDA ISSUES FY2008 MEDICAL DEVICE USER FEE SMALL BUSINESS GUIDANCE
  • GHTF Releases proposed guidance on STED for medical devices

PART 11: ELECTRONIC SIGNATURE/RECORDS  NEWS

  • FDA Part 11 Enforcement Resumes: Return of Audit Trail Requirement

QUALITY SYSTEMS NEWS

  • Japan to require ISO 13485:2003 registration by 1 April 2005
  • Orion Registrars delisted as CMDCAS recognised registrars

REGULATORY NEWS

  • FDA ISSUES FY2008 MEDICAL DEVICE USER FEE SMALL BUSINESS GUIDANCE
  • FDA Postpones 2008 Establishment Registration
  • FDA Proposes Reinspection Fees

 

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