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Resource Library

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We invite you to use our Medical Resource Library. Below you will find information pertaining to current and new EU's EMEA and US' FDA directives, relevant medical industry organizations and related publications.


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EU REGULATORY BODIES, DIRECTIVES, RESOURCES AND PUBLICATIONS
 

  1. European Medicines Agency
    http://www.ema.europa.eu/ema/index.jsp?curl=/pages/home/Home_Page.jsp&jsenabled=true
  2. European Directorate for the Quality of Medicines & Healthcare (EDQM)
    http://www.edqm.eu/en/Homepage-628.html
  3. Public Health European Commission
    http://ec.europa.eu/health/healthcare/information_sheet/pharmaceutical_pricing_reimbursement/index_en.htm
  4. European Commission Medical Devices Standards
    http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/list-references/medical-devices/
  5. European Commission CE Marking
    http://ec.europa.eu/enterprise/policies/single-market-goods/cemarking/
  6. Medicines and Healthcare products Regulatory Agency
    http://www.mhra.gov.uk/index.htm
     
    DIRECTIVES
  7. Directive 2.5/5 on Medical Device Labeling Translation Procedure
    http://ec.europa.eu/consumers/sectors/medical-devices/documents/guidelines/index_en.htm
  8. Active Implantable Medical Device Directive (AIMD)
    http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/list-references/implantable-medical-devices/index_en.htm
  9. In Vitro Diagnostic Directive (Dir 98/79/EC) IVDD
    http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/list-references/iv-diagnostic-medical-devices/index_en.htm
  10. Medical Device Directive (93/42/EEC) (MDD)
    http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/list-references/medical-devices/

    Directive requires companies to adopt a specific multilingual documentation process. This requirement compels companies to make provisions for translating documents pertaining to their product packaging, end-user instructions, labels and other essential product documentation. These are particularly important when it comes to user instructions since the device's safety and purported performance could be compromised due to incompetent translation.

US REGULATORY BODIES, DIRECTIVES, RESOURCES AND PUBLICATIONS
 

  1. USA Food & Drug Administration (FDA)
    http://www.fda.gov/
  2. US Department of Health and Human Services
    http://www.hhs.gov/
    http://www.cms.gov/
  3. US Medicare
    http://www.medicare.gov/default.aspx?AspxAutoDetectCookieSupport=1
  4. Office of Minority Health (CLAS)
    http://minorityhealth.hhs.gov/templates/browse.aspx?lvl=2&lvlID=15

    REGULATION
  5. Emergency Medical Treatment and Active Labor Act (EMTALA)
    https://www.cms.gov/EMTALA/
  6. Health Insurance Portability and Accountability Act
    http://www.hhs.gov/ocr/privacy/hipaa/understanding/index.html
  7. California SB853
    http://info.sen.ca.gov/pub/03-04/bill/sen/sb_0851-0900/sb_853_cfa_20030530_130357_sen_floor.html

INTERNATIONAL MEDICAL/PHARMA ORGANIZATIONS
 

  1. Society of clinical research organizations (SOCRA)
    http://www.socra.org/
  2. Association of clinical research organizations (ACRO)
    http://www.acrohealth.org/

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