Applicability:
Applies to an Establishment (Manufacturer/Wholesaler/Distributor) of medicine, scheduled substances, medical devices, and/or in-vitro diagnostics (IVDs) that manufacture, import, export, and/or act as a Wholesaler and/or Distributor.
Statutory/Regulatory Requirement:
All Medical Establishments (Manufacturers/Wholesalers/Distributors) are required by law to have a Medical Device Establishment License.
Such a license is issued upon the fulfillment of the regulatory model requirements that include, but are not limited to,
managing a (scope-relevant) quality management system which meets the recognised international standard for medical device establishments, i.e., ISO 13485.
Intention:
Ensuring that end-users have confidence in the safety and performance of medicine, scheduled substances, medical devices, and/or in-vitro diagnostics (IVDs) available for use.
Background (past/present):
On the 24 February 2017, a call-up notice was published in the Government Gazette (No. 40637) whereby Manufacturers and Distributors of medical devices were required to apply for a Medical Device Establishment Licence within six (6) months of the publication of said call-up notice, i.e., the initial deadline was 24 August 2017.
However, due to the delay in the accreditation of South African Conformity Assessment Bodies, the requirement to provide an ISO 13485 certificate upon application for renewal of a Medical Device Establishment Licence was extended for a period of three (3) years from the date of signing of the extension-notice and/or until further communication is shared by SAHPRA.
Click on the following link to access the extension notice:
Contact 9001 Consult for assistance to become ISO 13485 compliant by contacting us via telephone or e-mail or by logging a ticket on the Contact Us Tab or red Tag on the right-hand side of this page.
For clarity about what the process entails, please go to the Understanding/Approach Tab at the top of this page.