By Stewart Eisenhart, Emergo Group
South Africa’s Department of Health has released new draft regulations for medical devices and IVDs that accompanies proposed rules issued by the government in 2014.
The new rules incorporate feedback from industry following the government’s initial draft regulations published last year. Those rules included a four-tier device classification system, authorized representation requirements for foreign companies, proof of quality management system certification, and other requirements similar to those of other established regulatory systems in other countries. Oversight of the South African medical device registration process would be handled by the Medicines Control Council, a division of the Department of Health.
More tailoring for medical devices rather than drugs?
According to Brian Goemans, Country Manager for South Africa at Emergo, some of these latest revisions appear more finely tuned to medical device rather than pharmaceutical markets—but not all.
“There are some improvements in that the more ‘medicine-related’ clauses have been removed, but these regulations are still written to be applied by the Medicines Control Council, and some vestiges of the ‘medicine’ thinking remain,” Goemans observes.
As an example, he cites the provisions in the new draft for authorized representation; entities acting as in-country representatives must ensure adherence to the Medicines Act, which covers both devices and pharmaceutical products.
Foreign registration allowances
A promising provision in the draft regulations is the apparent allowance for registration of devices for manufacturers whose products have already been cleared or approved by other market regulators. Details, however, remain vague on this issue.
“Although the regulations allow for foreign registration with regulatory authorities in other countries, it has not yet been stated which registrations will be accepted for issue of a license for sale,” explains Goemans.
Implementation timeframes for the new regulatory system remain unknown. A one-month comment period will follow publication of the new regulations, but beyond that, no deadlines have been set. Goemans says the South African Parliament must enact relevant amendments to the Medicines Act in order for implementation to proceed.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.