Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

There are no registration requirements so I am OK?

 No! ● Import into countries generally requires import permit (tariffs) ● Initial application often requires labelling in local language and proof of compliance with other standards plus CFS ● High risk devices are most likely to attract attention ● WHO prequalification  Other items often required ● Letter of Authorisation

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Examples of No Regulation

 Some African Countries ● Algeria, Angola, Botswana, CAR, Chad, Congo, Djibouti, Egypt, Eritrea, Guinea Bissau, Lesotho, Liberia, Libya, Madagascar, Malawi, Mali, Mozambique, Namibia, Niger, Rwanda, Senegal, Swaziland, Togo, Tunisia, Uganda, Zambia  Some Caribbean Countries ● Antigua, Bahamas, Barbados, Cayman, Curacao, Dominican Republic, Haiti, Jamaica, St Kitts, St Lucia, St Vincent, Trinidad, Virgin Islands  Some Middle Eastern Countries ● Bahrain, Jordan, Kuwait, Lebanon, Oman, Qatar, Syria  Some Asia Pac Countries ● Bhutan, Brunei, Hong Kong, Macau, Mongolia?, Myanmar, PNG,

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