Module 19: Regulation of In Vitro Diagnostic Medical Devices

20/04/2023

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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There are registration requirements: General points

 You can split other regulated markets into the following: ● Accept CE mark DoC (or top 5) (plus CFS) – Albania requires a CE marked product plus language ● Accept CE data plus other requirements ● Requirements vary (eg East African countries)  Other items often required

● Letter of Authorisation ● Distribution agreement

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