You can trust us to guide you through the regulatory processes; we will be there every step of the way

Medical device licensing

There are 3 economic operator licenses in South Africa when it comes to medical devices. The type of license applied for depends on the activities performed by the medical device establishment/ organisation:


  • License to Manufacture, Import, Distribute or Export
  • Includes those that import bulk stock & re-pack/ service/ refurbishes devices


  • License to, Import, Distribute or Export
  • No re-packing/ refurbishing/ servicing allowed (i.e. manipulations not permitted, only sell as is)


  • Acquire stock from a local distributor & re-sale
  • No importing/ exporting permitted

We assist clients with the compilation of the relevant license (based on activities performed) for submission to the local Regulator (SAHPRA). Furthermore, we assist with the supporting documents such as the quality manual or site master file (SMF).

We also assist with post-licensing regulatory work:

  • Medical device license amendment (change in physical address, change in key personnel, change in company name, change in class of authorised medical devices & change in any other particulars of license holder reflected on the license certificate)
  • Medical device license notification
  • Medical device license renewals
  • General queries (e.g. Risk classification, documentation <medical device file>, adverse event reporting, GMDN, Vigilance of devices etc)

ISO 13485:2016 implementation/ internal audits/ maintenance

Medical device establishments have been mandated by the local Regulator (SAHPRA) to obtain certification to the international standard, ISO 13485:2016 Medical Devices, by the time of license renewal and the deadline for this requirement was pushed to 2025 (extended for 3 years in a communication guideline dated 17 Jan 2022). This means that any organization involved in one or more stages of the life-cycle of a medical device must comply with the requirements of ISO 13485:2016 international standard. The stages of a life-cycle of a medical device includes, but not limited to, the design and development, production, storage and distribution, installation, servicing, final decommissioning and disposal of a medical devices, or provision of associated activities (e.g. technical support).

We assist medical device establishments/ organisations with the following:

  • Establish, implement, audit, maintain and continually improve an ISO 13485:2016 Quality Management System (QMS)
  • Conduct baseline review of your medical device establishment’s position with regards to ISO 13485:2016
  • Identifying steps with which your medical device establishment/ organisation needs to take in defining, planning & implementing an ISO 13485: 2016 QMS
    • Performing gap analysis (reviewing the current system, if any, against the criteria (standard)
    • Implementation outline and process
    • Identifying risks and opportunities of your medical device establishment
  • Compilation of manuals, procedures, work instructions, forms or any QMS-related documents
  • Conducting internal audits (by our certified internal auditors):
    • First party audits: auditing your organization’s processes against the criteria (ISO 13485:2016 standard). Note: if we have assisted your organisation in the implementation your QMS then this may be an exclusion to our services as we cannot audit what we assisted in implementing.
    • Second party audits: conduct supply chain audits, on behalf of your company, at your external providers e.g. for contractual reasons or regulatory compliance.
  • ISO readiness: Preparation for Stage 1 / Stage 2 audits & audit responses to gain certification for ISO 13485: 2016 compliance. These third-party audits are to be conducted by SAHPRA-approved conformity assessment bodies (CABs)
  • Maintaining compliance/certification to ISO 13485: 2016
  • Effectively implement corrective actions & preventative actions (CAPAs)