South Africa is the biggest Medical device market in sub Saharan Africa and is heavily reliant on Imports.

Regulatory Authority

South African Health products Regulatory Authority (SAHPRA)

Regulatory Guidance for Medical Devices

• Medicines and Related Substance Act 1965
• Regulatory Guidance for Medical Devices

With Partner offices in South Africa, Lexium’s team in SAhas the expertise to help you navigate MHRA’s regulatory requirements and begin selling your device in SA.

Registration Process
• Appoint an authorized representative (AR) in South Africa
• Demonstrate the device meets essential principles
• Demonstrate conformity by applying to a conformity assessment body (CAB) or international notified body for the CA certificate
• If the application is successful and the CA certificate is granted the RA will now prepare DOC.
• Prepare necessary documentation including conformity Assessment body (CAB) & Doc.
• AR submits an application to the medicine control council s(MCC)
• A medical device will be included in the medical device register.

Documents Required
• Completed Application Form
• Labels, IFU, Package, Inserts or Promotional Material
• Letter of appointment as an authorized Representative of the original manufacturer
• Copy of the EC certificate issued by the recognized NB
• Copy of the EC declaration of conformity issued by the original manufacturer
• Technical Documentation

Let Lexium assist you with your South Africa’s Regulatory Approval Process

Lexium assists manufacturers to identify the device classification as a first step. Lexium helps client in procuring certification such as INMETRO and BGMP by helping in rectifying the regulatory hassles involved. Our partner companies are having vast experience in launching numerous devices in the region.

Post Approval Services

Lexium supports the foreign manufacturers in start to end medical device life cycle management, including post approval activities such as:

• Post approval change management, modifications to existing medical device approvals such as addition of new variants, accessories & addition of new indications of use among others.
• Maintenance of approvals and registration through timely payment of administrative & registration fees.
• Renewal of License
• Liaison between ANVISA and the Manufacturer
• Importation Arrangement

Lexium Expertise
• Regulatory Due Diligence Services
• Official Classification Services
• MDSAP Certification
• Economic Information Report (EIR) Services
• Device Registration Through the Right Pathway
• South African Authorized Representative (AR) Services
• Translation Services
• Labelling Services
• Distributor Identification & Qualification Services
• Operating Permits and Authorization
• Post Approval Change Management
• License Renewal and Transfer Services

Ready to get started – Request a free consultation