The South African Department of Health has published draft regulations for the country’s medical and in vitro diagnostic (IVD) device market for a three-month public comment period.

The proposed regulations would fall under South Africa’s Medicines and Related Substances Act of 1965, which would grant the health ministry’s Medicines Control Council the authority to oversee medical device and IVD registrations.

Classification

The South African regulatory system would include a four-tier, risk-based device classification system—Class A (lowest risk), Class B (low to moderate risk), Class C (moderate to high risk) and Class D (highest risk). The Medicines Control Council would determine proper classification of devices based on their designs and individual uses.

Required registration components

Foreign manufacturers would need to appoint in-country representatives to manage their medical device and IVD registrations in South Africa, according to the draft regulation. Through their authorized representatives, registrants would have to provide materials to Medicines Control Council reviewers such as:

• Proposed device labeling
• Proof of current quality management system certification
• Safety and performance data
• Country of origin and registration status data
• Clinical data, if applicable

The Medicines Control Council would then review registration applications and, for approved devices, issue registration certificates.

Next steps

The South African government’s proposed regulatory system would replace a current system in which only electromagnetic and radiation-emitting devices require registration and prior European CE Marking. But Brian Goemans, Country Manager for Emergo Group’s South African business, says the likelihood of this latest proposal becoming law in South Africa is still unclear.

“Given that medical device regulations have had several false starts in South Africa over the past several years, it’s too soon to know if these new regulations will come into force, and in what form,” Goemans says.

Emergo Group will provide more in-depth analysis of the proposed South African regulatory system as well as news regarding implementation as these details become available.

Stewart Eisenhart