Services

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

Medical Device Licensing & Regulatory Compliance

Navigating the medical device licensing process in South Africa requires a clear understanding of SAHPRA’s regulations. At Medical Maestros (Pty) Ltd, we assist medical device establishments in obtaining the correct economic operator license based on their activities.

Types of Medical Device Licenses in South Africa



Manufacturer

License to Manufacture, Import, Distribute, or Export
Includes businesses that import bulk stock, repackage, service, or refurbish medical devices



Distributor

License to Import, Distribute, or Export
No repackaging, refurbishing, or servicing allowed—devices must be sold as-is



wholesaler

License to Acquire stock from a local distributor and resell
No importing or exporting permitted

How We Assist

License Application & Submission – We compile and submit license applications based on your business activities.
Supporting Documentation – Assistance with preparing required documents such as a Quality Manual or Site Master File (SMF).

Post-Licensing Regulatory Support

License Amendments (e.g., change of address, personnel, company name, device class, or other details)
License Notifications & Renewals
Regulatory Compliance & Risk Management (e.g., risk classification, medical device documentation, vigilance reporting, adverse event management, GMDN codes)

With our expertise in regulatory compliance, we streamline the SAHPRA licensing process so your business remains fully compliant.

Contact Us Today

Let’s secure your medical device license with ease.

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. The deadline for this requirement was extended to 2025, as outlined in the 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.

The life cycle stages of a medical device include, but are not limited to, design and development, production, storage and distribution, installation, servicing, final decommissioning, disposal, and provision of associated activities such as technical support.

Our Services

We assist medical device establishments and organizations with:

Establishing, implementing, auditing, maintaining, and continually improving an ISO 13485:2016 Quality Management System (QMS).
Conducting a baseline review of your medical device establishment’s current position concerning ISO 13485:2016.
Identifying necessary steps for defining, planning, and implementing an ISO 13485:2016 QMS.
Performing a gap analysis—reviewing the existing system (if any) against the standard’s criteria.
Developing an implementation outline and process.
Identifying risks and opportunities for your medical device establishment.
Compiling manuals, procedures, work instructions, forms, or any other QMS-related documents.

Internal Audits

Our certified internal auditors conduct:

First-party audits – Auditing your organization’s processes against the ISO 13485:2016 standard. (Note: If we assisted in implementing your QMS, this service may be excluded to maintain audit integrity.)
Second-party audits – Conducting supply chain audits on behalf of your company at external providers for contractual or regulatory compliance.

ISO Readiness & Compliance

Preparing for Stage 1 and Stage 2 audits, including audit responses, to gain ISO 13485:2016 certification. These third-party audits are conducted by SAHPRA-approved conformity assessment bodies (CABs).
Maintaining ongoing compliance and certification to ISO 13485:2016.
Implementing effective corrective and preventive actions (CAPAs).

Let us help you navigate ISO 13485:2016 certification with ease—ensuring compliance, quality, and operational excellence.