EMERGO SUMMARY OF KEY POINTS

• The South African Medicines Control Council has set an August 2017 deadline for all domestic medical device manufacturers and distributors to register with the regulator.
• Domestic device wholesalers have until February 2018 to register with the MCC.
• The registration requirements do not apply to foreign companies, but they must still ensure that their South African importers obtain MCC licenses.

South Africa’s Medicines Control Council (MCC) has set a six-month deadline for domestic medical device and IVD manufacturers and distributors to apply for licensing in order to legally operate in the country.

New South African manufacturer and distributor requirements

According to the South African Government Gazette (page 19 of the PDF), by August 24, 2017, any device manufacturer or distributor that has not yet obtained a license from the MCC will have to submit a license application to the regulator. The application should include documentation covering the firm’s business information, Authorized Representative details and proof of quality management system certification. Applicants must also specify which groups or families of devices they deal with.

For medical device and IVD wholesalers, license applications must be submitted to the MCC by February 24, 2018.

Although MCC licensing requirements apply only to medical device companies based in South Africa, foreign manufacturers should bear in mind that they can only access the South African market through an importer based in the country; thus, foreign firms will need to verify that their South African importing partners comply with these new licensing deadlines to avoid any business disruptions.