Regulatory Control

1. Purpose

This document provides the process to meet regulatory requirements and covers the process for determining, establishing and maintaining regulatory compliance for ISO 13485 and market legislative requirements. 

2. Approval

(Version at end of page)

Signed V13 RB 15.07.2024

3. Scope

The process covers all products listed on the SAHPRA licence refer to the  QMS Cloud drive

4. Responsibilities

Approval: Author of the Document, Marelize Robertson

Changes: Author of the Document, Dean Kowalski

5. Definitions

None

6. Abbreviations

QMS - Quality Management System

SOP - Standard Operating Procedure

OEM - Original Equipment (Device) Manufacturer (maybe the Producer for a Brand manufacturer e.g. SAP Pharmacy, Dischem)

DoC – Declaration of Conformity

COA – Certificate of Analysis

SAHPRA - South African Health Products Regulatory Authority 

7. References

ISO13485:2016 4.1.1

www.sahpra.org.za regulations, guidelines and forms

http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en 

https://www.fda.gov/medicaldevices/

SOP Management Review 

SOP QMS Auditing

SOP Documentation

SOP Non-Conformance Corrective Action

SOP Adverse Incidents & Recall

SOP Change Control

Recall, Adverse Event, Post-Marketing Vigilance Reporting of Medical Devices and IVDs

8.Procedure

8.1 Regulatory Requirements 

 1.     Relevant country regulatory requirements are located on the website www.sahpra.org.za, also  http://www.sahpra.org.za/acts-and-regulations/  guidance from IMDRF refer website http://www.imdrf.org/documents/documents.asph. 

Countries; List to be developed [ territory, products listed, applicable legislation, Comments]

2. CE requirements are addressed by the manufacturer refer located http://ec.europa.eu/growth/single-market/european-  standards/harmonised-standards_en for the medical devices, but not limited to,

• Acts and regulations, 

• Licencing guideline and application, 

• Classification,

•  Essential principles, 

• Conformity assessment

3.    The following information should be available from the OEM, where applicable or accessible as required; 

• Medical Device (Technical File), 

• Declaration of conformity, 

• Conformity assessment certification, 

• Regulatory applications

4.    A review for compliance to processes and products is required and the QMS Auditing process is followed

5.    Advisory Notices, Vigilance and Adverse Incidents are covered in the Adverse Incident and/or Recall SOP

6.    Regulatory information and documentation will be updated as required from action from the review 6.2 or output of Management Review (SOP) or QMS Auditing (SOP)

7.    Amendments maybe made according to the SAHPRA at https://www.sahpra.org.za/ requirements.  Amendments will be recorded as SOP Documentation

8.    Should regulatory input or reporting be required e.g. Advisory Notices for Adverse Incident and/or Recall SOP is followed

8.2 Regulatory Application 

Refer to Regulatory Drive. 

8.3 Essential Requirements

8.3.1. For each quality management system process, the organisation has established and maintained records needed to demonstrate conformance to this International Standard and compliance with applicable regulatory requirements through the Google Site QMS

8.3.2. The organisation shall manage these quality management system processes in accordance with the requirements of this International Standard and applicable regulatory requirements. Changes to be made to these processes are controlled in accordance with the requirements of this International Standard and applicable regulatory requirements as per SOP Change Control. 

8.3.3 Actions in response to nonconforming product detected after delivery refer SOP Non-conformance Corrective Action. 

For the organisation to document procedures for issuing advisory notices in accordance with applicable regulatory requirements and be capable of being put into effect at any time as per SAHPRA guidelines refer SOP Adverse Incident and/or Recall

 8.4 Regulatory Schedule 

DEPARTMENT OF HEALTH, N0.1515 MEDICINES AND RELATED SUBSTANCES ACT, 1965 (ACT NO. 101 OF 1965), REGULATIONS RELATING TO MEDICAL DEVICES AND IN VITRO DIAGNOSTIC MEDICAL DEVICES (IVDs); SCHEDULE;

8.5 Responsibilities Definitions

"authorised representative" means a natural person, resident in the Republic of South Africa, who-

(a)    has the written mandate to represent a manufacturer, importer, distributor, wholesaler, retailer or service provider in the Republic

(b) acts on behalf of a manufacturer, importer, distributor, wholesaler, retailer or service provider for specified tasks with regard to the latter's obligations and in whose name manufacturer license, distributor license, wholesaler license or certificate of registration is issued; and

(c) is responsible for all aspects of the medical device or IVD, including performance, quality, safety and compliance with conditions of registration, clinical trials or clinical investigations;

ISO 13485:2016 3.2 authorised representative natural or legal person established within a country or jurisdiction who has received a written mandate from the manufacturer to act on his behalf for specified tasks with regard to the latter’s obligations under that country or jurisdiction’s legislation

[SOURCE: GHTF/SG1/N055:2009, 5.2]

9. Risk Based Approach

In the event of non-compliance follow SOP Non-Conformance Corrective Action. 

The Risk Assessment to is found in SOP PREVENTIVE ACTION RISK ASSESSMENT   refer Document

10. Revision History 

Revision 13; 15.07.2024 - RB - Change over to SharePoint Site

Revision 12; 25.07.2022 - MR -  DK 25.07.2022 - 11.  Updated and linked where records are maintained, added to references:  https://www.sahpra.org.za/wp-content/uploads/2020/01/Recalls_Vigilance_Medical_Devices_IVDs_Nov19_v3.pdf  

Revision 11; 14.10.2021 - MR - Updated 4. Responsibilities, 

Revision 10; 10.08.2021 - MR - Reviewed

Revision 9;  23.06.2021 - TNA - updating links and forms for new format - Approval / Scope / Responsibilities / Risk based approach / Revision  History

Revision 8; digitally signed 22.06.2020 by TNA

Revision 1-7; unknown due to google classic site changed to google new format site

11. Records

Name Retained in Retention period Hard copies Destroyed by

SAHPRA / MCC License application Google Drive indefinite n/a

 SAHPRA / MCC License issued (Previous) Google Drive indefinite n/a

SAHPRA / MCC License issued (Current) Google Drive indefinite n/a

SAHPRA Master information Cloud Drive indefinite n/a

Product Certificates / Technical Files Principal n/a n/a