With the focal point on regulatory and customer requirements, ISO 13485 is the most accepted standard worldwide for manufacturers of medical devices.

This standard is based on the ISO 9001 quality management system (QMS), but includes additional requirements specifically designed for the medical industry. ISO 13485 supports the reduction of unforeseen risks with regard to the devices and enhances the management thereof. This applies not only to companies that construct, produce and service medical devices, but also to organisations distributing and using them.


The South African government is in the process of implementing a licensing and registration procedure for all companies that import and manufacture medical devices. Companies will have to register their medical devices with the South African government or appointed regulatory authority to be able to supply to the South African Market. CE mark requirements, including a quality management system that complies with ISO 13485, will probably become mandatory for the registration purposes, although it could take time to promulgate the necessary acts. 

Living up to our promise to provide the best quality and design for all our products, we take pride in notifying our customers that Hutz Medical are putting all the processes in place to comply with the strict requirements of ISO 13485. The granting of our certification now depends on a rigorous auditing process that will be conducted in 2014. Our clients can be assured of the highest quality products that meet international standards!