Medical Device licenses are obtained from SAHPRA, the local regulator.

Licenses are issued according to the activities performed by the applicant. Contact your consultant or Consultico to assist.

Medical Device companies with a Manufacturing Establishment license and a Distribution Establishment License in South Africa need to implement a Quality Management System that aligns with ISO 13485 and SAHPRA regulations. They need to be certified by one of the SAHPRA approved Conformity Assessment Bodies (CAB).

For product-specific standards, we recommend searching for reliable resources or contacting Consultico for a consultation. With our many years of experience, we can help determine which standards apply to your product.

The main standards that apply to most medical device companies include ISO 13485, ISO 14791, ISO 15223-1, and IEC 62366.

For product-specific or country-specific standards, we recommend researching reliable sources or contacting Consultico for guidance.

This depends on the type of product, the intended use, the risk classification, and the market you want to access. We help determine the correct classification and identify which regulations and requirements apply. Many companies assume they fall under a single category, but most products overlap with multiple frameworks.

Yes. We assist with low-risk, moderate-risk, and high-risk devices, including IVDs and point-of-care technologies. The approach may differ depending on the class, but the support remains the same.

Yes. We help draft, compile, review, and update technical files. This includes structuring the file, identifying missing documents, correcting inconsistencies, and preparing content that aligns with regulatory expectations.

Yes. We help identify market-specific regulations, prepare the necessary documentation, and guide you through the steps needed for market access.

Yes. We offer training for teams that need support in understanding the requirements, implementing procedures, or maintaining a Quality Management System.

If you manufacture, distribute, or handle medical devices or IVDs, a QMS is expected regardless of company size. The system can be scaled to suit your operations, but it must cover the minimum requirements.

This depends on your current documentation, the state of your systems, and the standards or regulations you need to meet. Smaller gaps are resolved quickly; larger gaps require more structured work.

Yes. Some companies prefer to complete certain tasks internally. We can guide you, provide templates and procedures, and coach your team so that the work may be managed independently.