South Africa is the biggest Medical device market in sub Saharan Africa and is heavily reliant on Imports.
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.
- 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.
Let Lexium assist you with your South Africa’s Regulatory Approval Process
- 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
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
- 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