Overview

AC Consulting has been established by a number of Specialists from the Medical industory. The sharedknowledge and experience is over 35 combined in the Medical Device and Pharma field.

AC Consulting was established to provide expert advisory and regulatory services to the Medical Device industry.

Our consultants have a sound understanding of the regulatory environment in South Africa, its history, trends, processes and policies.

Our aim is to provide exemplary support for all your advisory and regulatory challenges.

 

The cornerstone of compliance

Classification of medical devices is the cornerstone of pre-market regulatory controls. The intent of the classification system and the controls for each class of medical device is to safeguard the health and safety of patients, users and other persons.

The outcome of the system is to group medical devices into one of four risk classes (A to D).

The first step in differentiation is to determine if the medical device is used for purposes of diagnosis of a medical disease / pathology / condition where the diagnostic activity takes place outside of the body i.e. in vitro. This type of medical device is termed an In vitro diagnostic (IVD) medical device.

All other medical devices, are referred to as “Non- IVDs”.

 

Classification rules for IVDs and Non-IVDs

Having chosen the correct “classification pathway” – it is necessary to work through the full list of rules to determine the correct classification of your product.

Since regulatory control of South African manufacturers and distributors of medical devices has not been in place – classification has not been necessary. This is all about to change!

Correct classification of your medical devices, using the South African classification rules, is critical to ensure you are enabled to meet the South African regulatory requirements.

 

Services

  • Advisory
  • Implimentation, Training and Development
  • Regulatory
  • - Medical Devices
  • - ApLicense Applications
  • - Site masterfile Preparations
  • - Standard Operating Procedures
  • - Auditing Services
  • - Quality Management System