This section contains information already published by SAHPRA and other organisations, and is intended to provide a consolidated list of documents relating to quality and regulatory requirements for Medical Technology in South Africa.

Covid Related documents

Acts

NATIONAL-HEALTH-ACT-61-of-2003_2-Sep-2013-to-date
Medicines-and-Related-Substances-Act-101-of-1965-_1-Jun-2017-to-date
HAZARDOUS-SUBSTANCES-ACT 15-OF-1973_24-Feb-2000-to-date

Regulations

101-of-1965-Guide-to-Regulations-and-Notices
N157-MCC-Licencing-Call-up
Medicines-Fees-payable-in-terms-of-the-provisions-20190524-GGN-42474-00695
Regulations-relating-to-Medical-Devices-and-IVDs-20161209

Guidance Documents

2.32-Wound_Dressings_Nov11_v1
2.45-Borderline_Products_Feb17_v1_for_comment
4.02-SA-Guide-to-GWP-v2-Nov15-MEDS
5.07-Recall-Guideline-for-Medical-Devices-Showing-Changes
6.04-Licence_Wholesaler_Medical_Devices_IVDs_Apr17_v1_for_comment
8.01-General-Information
8.02-Medical_Device_IVD_Essential_Principles_Nov19_v2
8.03-Conformity-Assessment-for-Medical-Devices-for-comment
8.04-Recalls_Vigilance_Medical_Devices_IVDs_Nov19_v3
8.05-Classification-Medical-Devices-IVDS
8.06-Access_and_Control_Medical_Devices_IVDs_Apr17_v1_for_comment
8.07-Medical_Device_Quality_Manual_Jun17_v2
8.10-QA_Licensing_Medical_Devices_Nov17_v1
9.76-Disinfectants_Antiseptics_Germicides_v1_Jul16
9.79-Medical_Device_Establishments_Licence_Sept16_v1
9.96-Transitional_Arrangements_Medical_Devices_Apr17_v1
9.103-Tissue_Engineering_Products_Nov17_v1
9.105-Section_21_Medical_Devices_Sept17_v1
9.106-Class_A_Medical_Devices_Sept17_v1
9.106_Class_A_Medical_Devices_Sept17_v1
9.119-Medical_Devices_Section_36_exemption_Sections_18A_B_Dec18_v1
10_Q_A_Licensing_Medical_Devices_Nov17_v1-2
16.03-Licence_Medical_Devices_IVDs_Nov19_v3
16.04-Licence_Wholesaler_Medical_Devices_IVDs_Apr17_v1_for_comment

Position Statements

MD020-Certificate-of-Free-Sale_v2-22072020
20180201_SAHPRA-Registration_Medical-Devices_Call-up-plan_v1
Communication-to-industry_licence_AcknowledgementLetter_Nov2019
Communication-to-industry_licence_amendment_Nov2019