This Standard is based on the requirements of ISO 9001:2008, and includes additional requirements for medical devices, including risk management.

The standard has been revised in 2016, and unlike the management system standards for quality (ISO 9001:2015), environmental (ISO 14001:2015) and safety (ISO 45001:2016), the high level structure of ISO 13485:2016 has not changed in line with Appendix SL of the ISO/IEC Directives, Part 1.

So the structure of ISO 13485:2016 is based on the 2008 version of ISO 9001.

As from about the first quarter of 2018, new certification assessments will only be conducted to the 2016 version, and from about the first quarter of 2019 certificates not to the 2016 version will be invalid.

South African Legislation

Legislation has been drafted to require companies that manufacture or sell medical devices in South Africa to register their company and each device category with the South African Medical and Dental Council.

A Government Gazette has been published which outlines the requirements.

Indications are that these requirements will be similar to those in ISO 13485 and those for CE marking.

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