The South African Medicines Control Council (MCC) has issued draft regulations as well as Essential Principles for the mandatory registration of medical and in vitro diagnostic devices. Currently, only listed electro-medical devices and devices with pharmaceutical components require registration in the country.

The proposed legislative framework for device and IVD regulations employs recommendations from the International Medical Device Regulators Forum (IMDRF), and would also recognize “local and international medical device and IVD standards and conformity assessment standards” for South African registration purposes.

Proposed registration components

In draft form, the South African medical device regulatory framework fortunately does not attempt to reinvent the wheel in terms of registration requirements. Elements of the framework include:

• A four-tier classification system based on risk (Classes A, B, C and D)
• Authorized representation requirements for manufacturers with no presence in South Africa
• Essential Principles covering medical device and IVD quality, safety and performance
• Post-market surveillance of devices already registered for sale in the country

Registration applications would be submitted to the MCC’s Registrar of Medicines for approval; the MCC would reserve the right to evaluate conformity assessment documents for Essential Priniciples compliance.

Implications and questions

According to Brian Goemans, Country Manager for Emergo’s South Africa business, the new draft guidance show promising signs, but also raises some significant questions.

“These guidances were released under the MCC rather than the South Africa Health Products Regulatory Authority, as had been proposed, and closely follow IMDRF concepts,” says Goemans. “They also clearly differentiate between medical devices and medicines.”

However, Goemans also points out issues raised by the new proposals: Mistakes such as referencing defunct standards, inappropriate examples used for classification, and circulation of the proposals to pharmaceutical manufacturers but not medical device manufacturers.

South African regulators have set up a three-month time period for comments on the draft regulations and Essential Principles.