South Africa Unveils New Regs Covering Devices, Diagnostics

South Africa’s Department of Health and Medicines Control Council is gearing up to implement the country’s first regulatory system covering medical devices and in vitro diagnostics.

The new regs are covered in four separate documents that cover licensing and importing medical devices and IVDs, classification of devices and IVDs, good manufacturing practices, and general safety principles.

South Africa’s Medicines Control Council released the proposed regulations in September 2015, and sought public comments (IDDM, Oct. 16, 2015).

The updated regs lay out a risk-based classification system based on good manufacturing practices. The updated document provides additional information on postmarketing safety requirements and reporting adverse events.

Under the risk-based classification system, there are four classes of devices or diagnostics:

• Class A – low risk;
• Class B – low to moderate risk;
• Class C – moderate to high risk; and
• Class D – high risk.

For licensing a Class C or Class D device or IVD in South Africa, manufacturers will need to show proof of premarket approval or registration from at least one regulatory authority in Australia, Brazil, Canada, the European Union, Japan, U.S. or the World Health Organization Prequalification status.

Read the final licensing guidelines here: www.fdanews.com/08-24-16-SouthAfricaguidelines.pdf and here: www.fdanews.com/08-26-16-SouthAfricaClassification.pdf, www.fdanews.com/08-26-16-SouthAfricasafetyprinciples.pdf, www.fdanews.com/08-26-16-SouthAfricageneralprinciples.pdf. — Tamra Sami