South African Medical Device Regulatory System Set for Implementation
The South African government has set an August 2016 implementation date for registration of domestic medical device manufacturers, importers and distributors first proposed in late 2015.
According to new guidelines issued by the South African Department of Health and Medicines Control Council (MCC), the new regulations apply to the manufacturing, importing, exporting and distribution of medium- and high-risk devices. Class B, C and D devices as well as IVDs fall under the scope of the new requirements, while low-risk Class A devices are exempt. Although MCC licensing requirements applies to local companies, foreign manufacturers exporting to South Africa will also be affected; foreign firms will have to provide their importers and local distributors with basic device information including Global Medical Device Nomenclature (GMDN) codes, Certificates of Free Sale (CFS) from reference countries for Class C and D devices, and CFSs or Certificates to Foreign Countries (CFG) for Class B and D devices.
The components of the proposed South African system, first reported by Emergo in July 2015, include a four-tier, risk-based classification system, as well as requirements for obtaining licenses for device and IVD manufacturers, importers and distributors.
Proof of registration in other markets
The latest version of the MCC guidance includes specific requirements that manufacturers and distributors of moderate- to high-risk Class C and D devices and IVDs show proof of market registration with one or more of the following regulators as part of their South African registration:
- Australian Therapeutic Goods Administration (TGA)
- Brazil’s ANVISA
- Health Canada (Medical Device License)
- European Competent Authority (CE Marking)
- Japanese Pharmaceuticals and Medical Devices Agency (PMDA) (Marketing Authorization Holder License)
- US FDA (510(k) premarket notification or Premarket Authorization (PMA))
Manufacturers and distributors of Class B, C and D devices and IVDs seeking MCC registration must also provide Certificates of Free Sale (CFS) from countries where they are produced.
Additional specified requirements
The new guidance also specifies that manufacturers and distributors applying for MCC licenses must also be able to submit full technical documentation on their devices or IVDs to the South African regulator on request.
Foreign manufacturers will need to support their importers and/or distributors in South Africa with the required Free Sales Certificates and technical documentation. The South African importer/distributor will have to appoint a natural person to be the Authorised Representative.
“Note that the Authorised Representative is a natural person, not a legal entity,” says Brian Goemans, Country Manager for Emergo’s South Africa business. “This person is responsible to the regulator for all activities including importation, transportation, storage, distribution, marketing and sales.”
According to the MCC, domestic manufacturers must apply for South African registration between August 1, 2016 and January 31, 2017.