![\"Bandeira](\"https:\/\/passarini.com.br\/wp-content\/uploads\/2023\/08\/1920x500_banner_EN_country_South-Africa-scaled.webp\")
<\/span><\/li><\/ul><\/div><\/div><\/div><\/div><\/div><\/div>Medical device regulation in South Africa<\/h2>\n
The regulation of medical devices in South Africa is carried out by the South African Health Products Regulatory Authority (SAHPRA<\/a>). This government agency is responsible for ensuring that all medical devices marketed in the country are safe, effective and of high quality.<\/p>\n
The regulatory process involves a detailed assessment of each device, taking into account factors such as its composition, functionality, associated risks and clinical efficacy. Medical devices are classified into categories, depending on the degree of risk they present to patients and users.<\/p>\n
Check out some of the services we provide in South Africa:<\/p>\n<\/div>
- <\/i><\/span>\n
Classification Recommendation<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nMedical Device Compliance Review<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nLicense Amendment (Hosting) or License Application<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nAmendment (Hosting) or Submission of Application<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nImportation Administration<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nDistribution Administration<\/p>\n<\/div><\/li><\/ul>
<\/div><\/div><\/div>1. Classification Recommendation<\/h2>\n
The starting point for all medical devices and IVDs intended for the South African
\nmarket undergo a formal classification and compliance review according to the local
\nguidelines, following the receipt of the following technical documentation:<\/p>\n<\/div><\/i><\/i><\/span>Label Artwork<\/span><\/a><\/h4><\/div>
<\/div><\/div><\/div><\/i><\/i><\/span>Instructions for Use Artwork<\/span><\/a><\/h4><\/div>
\nYour Content Goes Here<\/p>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Manufacturer\u2019s ISO13485:2016 Certificate<\/span><\/a><\/h4><\/div>
\nYour Content Goes Here<\/p>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Product Declaration of Conformity (Class A and B devices)<\/span><\/a><\/h4><\/div>
\nYour Content Goes Here<\/p>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Product Originating Approval (for Class C and D devices)<\/span><\/a><\/h4><\/div>
\n- \n
- MHRA UK<\/li>\n
- Japan PMDA<\/li>\n
- ANVISA<\/li>\n
- Health Canada<\/li>\n
- Australian TGA<\/li>\n
- US FDA PMA<\/li>\n
- WHO<\/li>\n<\/ul>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Product GMDN Code<\/span><\/a><\/h4><\/div>
\nYour Content Goes Here<\/p>\n<\/div><\/div><\/div><\/div><\/div>
The medical device regulatory framework has a classification system for medical
\ndevices and IVDs, as per the medical device Regulations of Act 101 of 1965 set out
\nin the Classification Rules of Medical Devices. The manufacturers intended us of the
\nmedical device is crucial when determining the classification of a medical device.<\/p>\nMedical devices are classified in the following levels:<\/p>\n<\/div>\n
\n
- <\/i><\/span>
- <\/i><\/span>
![](\"https:\/\/passarini.com.br\/wp-content\/uploads\/2023\/08\/Fluxo_Etapas_EN_South-Africa_Process_SAHPRA-400x242.webp\")
<\/a>