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 V12 TNA 24.08.2021
3. Scope
The process covers all products listed on the SAHPRA licence refer REGULATORY DRIVE Folder
4. Responsibilities
Approval: Author of the document, Alexi Arhondonis
Changes: Author of the document, Alexi Arhondonis
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 Non-Conformance Corrective Action
SOP Adverse Incidents & Recall
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 REGULATORY DRIVE
8.3 Essential Requirements
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
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
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 Assessment to is found in SOP PREVENTIVE ACTION RISK ASSESSMENT refer Document]
10. REVISION HISTORY
Revision V12 TNA 24.08.2021 amended link for List of External Documentation
Revision V11 AA 19.08.2021 Updated Responsibilities
Revision V10 AA 03.05.2021 Approved
Revision 9, 23.04.2021 - TNA - New format with Approval, Scope, Responsibilities, Risk based approach and Records added and new google site format. Amended links and forms
Revision 8, Digitally signed on 18.06.2020 by AA
Revision 1-7, unknown due to google site change to new google site
11. RECORDS
Name Retained by/ in Retention period Hard copies Destroyed by
REGULATORY DOCUMENTATION REGULATORY DRIVE indefinite n/a
LIST OF EXTERNAL DOCUMENTS DRIVE folder indefinite n/a