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 ISO13485 and market legislative requirements 

2. Approval

(Version at end of page)

Signed V2 NG 23.01.2025

3. Scope

The process covers all products listed on the SAHPRA licence refer DRIVE folder

4. Responsibilities

Approval: Bruce Manuel

Changes: Nicholas Gilbert

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

ISO13485 Clause 5 & 8.2.3

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

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 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 Regulatory Drive  - licence application / Medical Device Information held on file. 

8.3 Essential Requirements

(ISO 13485 4.1.3) For each quality management system process, the organization has established and maintained records needed to demonstrate conformance to this International Standard and compliance with applicable regulatory requirements through the Google Site QMS

(ISO 13485 4.1.4) The organization 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

(Clause 13485 8.3.3) Actions in response to nonconforming product detected after delivery refer SOP Non-conformance Corrective Action

For the organization 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 licence, distributor licence, wholesaler licence 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;

ISO13485:2016 3.2 authorized 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]

EU Article 15 Person responsible for regulatory compliance

1. Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices. The requisite expertise shall be demonstrated by either of the following qualifications:

(a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices;

(b) four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.

Without prejudice to national provisions regarding professional qualifications, manufacturers of custom-made devices may demonstrate the requisite expertise referred to in the first subparagraph by having at least two years of professional experience within a relevant field of manufacturing.

(35) For manufacturers who are not established in the Union, the authorised representative plays a pivotal role in ensuring the compliance of the devices produced by those manufacturers and in serving as their contact person established in the Union. Given that pivotal role, for the purposes of enforcement it is appropriate to make the authorised representative legally liable for defective devices in the event that a manufacturer established outside the Union has not complied with its general obligations. The liability of the authorised representative provided for in this Regulation is without prejudice to the provisions of Directive 85/374/EEC, and accordingly the authorised representative should be jointly and severally liable with the importer and the manufacturer. The tasks of an authorised representative should be defined in a written mandate. Considering the role of authorised representatives, the minimum requirements they should meet should be clearly defined, including the requirement of having available a person who fulfills minimum conditions of qualification which should be similar to those for a manufacturer's person responsible for regulatory compliance.

9. Risk Based Approach

In the event of non compliance follow SOP  NON CONFORMANCE CORRECTIVE ACTION

Risk Based Approach Report

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

10. REVISION HISTORY

Revision 2 NG 23.01.2025 Changed Ownership

Revision 1 New HJM 5.09.2024

11. RECORDS

Name Retained by/ in Retention period Hard copies Destroyed by

REGULATORY DOCUMENTATION DRIVE folder indefinite n/a