Regulatory Authority
SAHPRA, South Africa Health Products Regulatory Authority
Classification
A, B, C, D
Quality system
ISO 13485:2016
No Medical Device may be manufactured, distributed, imported, exported or sold without a valid SAHPRA establishment license. Information on the Medical Devices to be marketed in the territory (of which a specific listing is made during the process) and the manufacturer’s system certifications must be included in the related application. Product registration is to this date still an ongoing process under development and not yet operational.
Applicant
Medical Device manufacturers who have applied for an establishment license must appoint an Authorized Local Representative, physically located in South Africa and responsible for compliance with local law, regulations and guidelines.
Timeframe and fees
Approximately 6-8 weeks are required for the establishment license upon payment of initial fee $1,010. An annual fee of $282 is charged for renewal.
Validity
Licence: 5 years
Labelling and documentation language
Documentation and labelling must be provided in English.
Useful information
The product registration process is currently being finalized by the South African Health Products Regulatory Authority (SAHPRA). It will be based on the type and class of device and will be formalized in the forthcoming “Registration Call-Up Plan.”
