SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAHPRA)

EXPRESSION OF INTEREST 

Independent Expert Review of South Africa’s Draft Medical Devices Regulations 

Issued by: South African Health Products Regulatory Authority (SAHPRA) 

CALL FOR EXPRESSIONS OF INTEREST FROM MEDICAL DEVICES REGULATORY EXPERTS 

The South African Health Products Regulatory Authority (SAHPRA) is South Africa’s national regulatory authority responsible for the regulation of health products, including medicines, medical devices, In Vitro Diagnostic (IVDs)medical devices, radiation-emitting products and related health technologies, with a mandate to ensure access to safe, effective and quality health products. 

SAHPRA invites suitably qualified medical devices regulatory experts to submit an Expression of Interest to conduct an independent expert review of South Africa’s revised draft Medical Devices Regulations. 

This Expression of Interest is targeted at individuals with demonstrable expertise in medical devices regulation, particularly those affiliated with, or who have contributed to, the International Medical Device Regulators Forum (IMDRF), the African Medical Devices Regulatory Forum (AMDRF), or who are currently or previously employed by regulatory authorities responsible for the oversight of medical devices and in vitro diagnostic medical devices. The purpose of this process is to identify and appoint an independent expert or panel of experts who can provide an objective assessment of the draft regulations prior to their finalisation and implementation. 

BACKGROUND

South Africa has revised its Medical Devices Regulations under section 35 of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965). The revised regulations are intended to replace the current Regulations Relating to Medical Devices and In Vitro Diagnostic Medical Devices published in Government Gazette No. 40480 of 9 December 2016. The draft regulations have undergone public consultation, including consideration of comments from industry, professional associations, public health stakeholders and other interested parties. The final regulatory package has also been supported by a Socio-Economic Impact Assessment (SEIAS) sign-off process. 

PURPOSE OF THE ASSIGNMENT 

The appointed expert will be required to provide an independent written review of the revised draft Medical Devices Regulations, and assess whether the regulations are globally aligned, contextually appropriate for Africa and South Africa, and capable of enabling a safe, competitive and sustainable South African medical devices industry. 

SCOPE OF THE INDEPENDENT REVIEW 

1. Global alignment: assess the extent to which the draft regulations align with IMDRF principles and related international good regulatory practices, including risk-based classification, essential principles of safety and performance, conformity assessment, vigilance, reliance, clinical evidence, software as a medical device, post-market surveillance and quality management systems. 

2. Regulatory reliance and convergence: comment on whether the regulations create sufficient enabling provisions for reliance on trusted regulatory authorities, recognised conformity assessment bodies, WHO Prequalification, Medical Device Single Audit Program (MDSAP) /ISO 13485 evidence and internationally accepted technical documentation, while preserving SAHPRA’s sovereign decision-making authority. 

3. Relevance to the African context: assess the appropriateness of regulations for implementation in an African regulatory environment, including regional harmonisation, alignment with AMDF and African Medicines Regulatory Harmonisation (AMRH) objectives, scarce regulatory capacity, cross-border trade, public sector procurement realities and access to essential diagnostics and medical technologies. 

4. Relevance to the South African context: review whether the regulations adequately address South Africa’s health system realities, including public and private sector use, rural access constraints, digital access limitations, post-market vigilance, importation routes, local accountability, use of local authorised representatives, and the need for traceability and patient protection. 

5. Impact on industry enablement: assess whether the regulations are likely to enable or constrain the South African medical devices industry, including local manufacturers, importers, distributors, wholesalers, service providers, diagnostic laboratories and innovators, and whether they support competitiveness, investment, innovation and regional export potential. 

6. Implementation feasibility: provide an opinion on whether the requirements are proportionate and practically implementable, particularly in relation to product registration, call-up notices, transitional arrangements, labelling, instructions for use, electronic information, ISO 13485 certification, conformity assessment body recognition, timelines and regulatory capacity. 

7. Key risks and unintended consequences: identify any provisions that may unintentionally restrict access to medical technologies, increase regulatory burden without commensurate public health benefit, create ambiguity in supply-chain responsibilities, duplicate international controls, or impede South Africa’s role as a regional medical devices hub. 

8. Recommendations: provide concrete recommendations on amendments, clarifications, guidance documents, transitional mechanisms or implementation sequencing that would strengthen the regulations prior to their finalisation. 

ELIGIBILITY CRITERIA 

·       Respondents should meet one or more of the following criteria: 

·       demonstrated expertise in medical devices and/or in vitro diagnostic medical devices regulation; 

·       current or previous affiliation with IMDRF, AMDRF, or related international or regional medical devices regulatory harmonisation initiatives; 

·       current or previous employment by a regulatory authority responsible for the regulation of medical devices or in vitro diagnostic medical devices; 

·       experience in regulatory reliance, convergence, conformity assessment, classification, clinical evidence, vigilance, post-market surveillance, quality management systems, or software as a medical device; 

·       understanding of regulatory implementation in low- and middle-income country contexts, preferably including African regulatory systems; and 

·       ability to provide an independent, evidence-based and practical written assessment within the agreed timeframe. 

DOCUMENTS TO BE MADE AVAILABLE 

For purposes of the review, SAHPRA will provide the revised draft Medical Devices Regulations, the consolidated responses to public comments, and the SEIAS sign-off documentation. These documents reflect the policy intent, stakeholder concerns and regulatory rationale underlying the current draft. 

EXPECTED DELIVERABLES 

We would appreciate a written independent review report that includes an executive summary, a high-level assessment of the overall regulatory approach, clause-specific or thematic comments where necessary, a view on readiness for implementation, and clear recommendations for strengthening global alignment and local applicability. Where appropriate, the report may distinguish between matters that should be addressed in the regulations themselves and matters that could be addressed through guidelines, transitional plans, implementation notices or operational procedures. 

SUBMISSION REQUIREMENTS 

Interested experts are invited to submit an Expression of Interest containing the following information: a brief motivation indicating suitability for the assignment; a curriculum vitae; details of relevant regulatory experience; a declaration of current or previous affiliation with IMDRF, AMDRF or a medical devices regulatory authority; confirmation of independence and absence of conflict of interest; availability to complete the assignment within four to six weeks from receipt of the full document pack; and an indication of proposed fees or remuneration expectations, where applicable. 

EVALUATION OF EXPRESSIONS OF INTEREST 

Expressions of Interest will be considered based on relevant medical devices regulatory expertise, demonstrated international or regional regulatory experience, familiarity with IMDRF and/or AMDF principles, understanding of African and South African public health and regulatory contexts, independence, availability, and ability to produce a clear and practical expert report. 

INDEPENDENCE AND CONFIDENTIALITY 

The review will be an independent expert assessment and should not be construed as an endorsement by IMDRF, AMDF or any regulatory authority unless formally authorised through the appropriate institutional processes. SAHPRA will treat the findings as expert advisory input to support evidence-informed regulatory decision-making. Any non-public documentation shared for purposes of the review must be treated as confidential and used only for the agreed purpose. 

PROCEDURE

·       Expressions of Interest must be submitted online at https://apply.sahpra.org.za:6006

·       Only documents in pdf must be uploaded. 

·       Further communication will be limited to nominated candidates with appropriate skill sets. 

·       Closing date for nominations is Friday, 11 September 2026 at 16h30. No late submissions will be accepted. 

Enquiries: Office of the CEO at CEOOffice@sahpra.org.za

The South African Health Products Regulatory Authority (SAHPRA) is the National Medicines Regulatory Authority established in terms of the Medicines and Related Substances Act, 101 of 1965, as amended, to monitor, evaluate, regulate, investigate, inspect, register and control medicines, schedule substances, clinical trials and medical devices, including IVDs, and related matters in the public interest. 

TECHNICAL OFFICER: MEDICAL DEVICES COMPLIANCE 

SALARY: 562,800.00 – 681,300.00 PER ANNUM (TOTAL COST TO COMPANY) 

Ref No.: SAHPRA 32 of 2026/27 

CENTRE: PRETORIA 

REQUIREMENTS: ● A matric/grade 12 certificate and a degree in Natural/Medical Sciences/Clinical Engineering/Pharmacy at NQF level 8 as recognised by the South African Qualification Authority. A postgraduate qualification will be an added advantage. The candidate must be registered with a relevant professional body where applicable. 

A minimum of 3 years’ experience, including at least 2 years in the medical devices and in-vitro diagnostics (IVDs) regulatory environment, with knowledge and understanding of regulatory compliance, quality management systems (QMS) and legislative requirements for medical devices licensing. 

CORE COMPETENCIES, TECHNICAL PROFICIENCIES, AND VALUES: 

·       Strong knowledge and understanding of Medicine and Related Substances Act No. 101 of 1965 and Regulations with specific application to the regulation, licencing and handling of medical devices and IVDs. 

·       Computer literacy and Microsoft applications. 

·       Good report writing and presentation skills. 

·       Good planning and organisational skills. 

·       Good verbal and written communication skills. 

·       Self-motivated and ability to work independently. 

·       Ability to manage a variety of cross-functional team members. 

·       Strong attention to detail and ability to evaluate information accurately. 

·       Ethical conduct and adherence to the SAHPRA Code of Conduct. 

·       Demonstrate SAHPRA’s values in the execution of their duties. 

DUTIES:

·       Evaluate and manage licence applications for medical device establishments and ensuring accurate records and up to date databases. 

·       Prepare compliance-related reports for SAHPRA and relevant advisory committees to support regulatory decision-making. 

·       Assist in capturing the recommendations of relevant SAHPRA advisory committees relating Medical Devices Unit. 

·       Liaise with international regulatory authorities. 

·       Monitor compliance with the provisions of the Medicines Act and other health related legislations applicable to medical devices and IVDs. 

·       Draft, develop and review guidelines and Standard Operating Procedures for licencing of medical devices as per organisational requirements. 

·       Proactively audit processes, practices, guidelines, and Standard Operating Procedures for licencing of medical devices. 

·       Facilitate training for employees who are responsible for licencing of medical devices on matters regarding changes in the legislation and updates on compliance guidelines. 

·       Investigate complaints raised by Regulatory Compliance Unit regarding noncompliance with the Medicines Act and other health related legislations relating to medical devices and IVDs. 

·       Keep industry stakeholders informed about SAHPRA Board resolutions and legislative requirements regarding medical devices and IVDs. 

·       Investigate and attend to the queries of the industry stakeholders or applicants. 

·       Capture and maintain data performance data, peer-reviewed reports, and related statistics 

·       Manage risks regarding licencing of medical devices, handle audit queries, and correspondence from applicants and stakeholders. 

·       Submit weekly work plans and output reports to the Medical Devices Unit manager 

·       Perform other related functions that as required from time to time. 

HOW TO APPLY (INSTRUCTIONS TO APPLICANTS): 

·       Interested candidates who meet the above requirements should submit their applications, clearly indicating the title of the position and the reference number. Applications must include a signed cover letter, a detailed Curriculum Vitae (CV) with the names and email addresses of three (3) referees, and certified copies of the required qualifications (including matric). Only shortlisted candidates will be required to submit certified copies of qualifications and other relevant documents on or before the interview date, as communicated by Human Resources. 

·       Should you have a foreign qualification, your application must be accompanied by an evaluation certificate (report) from the SAQA. 

·       Incomplete applications or applications without the aforementioned documents or information will not be considered. 

·       No late applications will be accepted. Any submissions received after the closing date and time will not be considered. 

·       Due to the anticipated high volume of applications, communication will be limited to short-listed candidates only. Candidates who have not been contacted within three (3) months after the closing date, should consider their application unsuccessful. 

·       Shortlisted candidates will be expected to attend selection interviews on a specific date, time, and location as communicated by SAHPRA. 

·       Applicants should note that pre-suitability checks will be conducted after they have been shortlisted. Their appointment is subject to positive outcomes from these checks, which include security clearance, verification of qualifications, criminal records, credit checks, citizenship status, and work experience. 

·       SAHPRA is committed to being an equal opportunity employer. When filling vacant positions, the entity will consider the principles outlined in Section 195(1)(i) of the Constitution of the Republic of South Africa, Act 108 of 1996, and the Employment Equity Act, 55 of 1998. 

·       People with disabilities (should indicate their disability status), males (all races) and females (Coloured and White) will be given preference. 

·       SAHPRA reserves the right not to appoint any candidate to the advertised post. 

·       SAHPRA adheres to the provisions of the Protection of Personal Information Act (POPIA), 4 of 2013. CVs will not be returned, as the personal information you provide will be used solely for recruitment purposes, specifically for the position or vacancy you have applied for. If your application is unsuccessful, your personal information will be retained for internal audit purposes. 

·       Applications should be submitted through the SAHPRA Website Online Portal: http://www.sahpra.org.za/vacancies

·       For enquiries: Please contact Mr T Khunou or Ms B Rakgotho, HR Business Partners, via email at Tshepo.Khunou@sahpra.org.za or Bafedile.Rakgotho@sahpra.org.za

NOTE: APPLICATIONS SUBMITTED TO HIS EMAIL ADDRESS WILL NOT BE CONSIDERED AS PART OF THE RECRUITMENT PROCESS. 

The closing date is 04 September 2026 at 16:00.

The South African Health Products Regulatory Authority (SAHPRA) is the National Medicines Regulatory Authority established in terms of the Medicines and Related Substances Act, 101 of 1965, as amended, to monitor, evaluate, regulate, investigate, inspect, register and control medicines, schedule substances, clinical trials and medical devices, including IVDs, and related matters in the public interest. 

ADMIN SCREENER - CLINICAL TRIALS 

SALARY: R 271,900.00 – R 321,000.00 PER ANNUM (TOTAL COST TO COMPANY) 

Ref No.: SAHPRA 31 of 2026/27 

CENTRE: PRETORIA 

REQUIREMENTS: A matric certificate and an appropriate post - matric qualification in Business Administration or similar at NQF Level 5 as recognised by the South African Qualifications Authority (SAQA). A National Diploma at NQF 6 will be an added advantage. The candidate must have a minimum of 1 – 2 years of administrative experience in a regulatory environment and possess basic knowledge in a pharmaceutical environment. 

COMPETENCIES, KNOWLEDGE, AND SKILLS: 

·       Knowledge and application of the Medicines and Related Substances Act No. 101 of 1965 as amended, and its related Regulations. 

·       Data capturing skills 

·       Strong administrative and organisational skills. 

·       Willingness to work extended hours as and when required. 

·       Be dedicated, deadline driven and pay attention to details. 

·       Innovative thinking. 

·       Be a team player, but also able to work independently. 

·       Must have interpersonal and communication skills (written and verbal). 

·       Must have good customer service. 

·       Computer skills. 

·       Maintain a high level of accuracy in preparing and entering information and attention to detail. 

·       Ability to maintain high levels of confidentiality. 

·       Proactive Stakeholder Management. 

DUTIES:

·       Upload applications and related documentation as outlined in the standard operating procedures. 

·       Receive and sort electronic applications from industry. 

·       Capture information in the database as outlined in the standard operating procedures 

·       Screen applications according to the checklist and identify missing documents. 

·       Assess applications according to the relevant electronic administrative checklist. 

·       Submit queries resulting from screening and applicants to the relevant Medicine Control Officer or Medicine Registration Officer or Manager. 

·       Communicate outcomes of the screening process to the applicants. 

·       Ensure the business unit complies with the approved standard operating procedures. 

·       Manage and update the electronic data storage. 

·       Regularly generate correspondence and allocate to the technical staff ((protocol amendments, additional investigators/ sites and other notifications correspondence). 

·       Ensure that the tracker of applications/correspondence is updated regularly. 

·       Prepare correspondence for protocol amendments, additional amendments, additional investigators and sites and other notifications. 

·       Acknowledge applicants through letters or notifications. 

·       Check proof of payments and ensure that portfolio of evidence on applications or correspondences is saved regularly at area of work (available for reporting). 

·       Attend to internal and external audit queries. 

·       Arrange Expert Committee meetings. 

·       Capture minutes of the Expert Committee or Business Unit meetings. 

·       Ensure that the claim forms are processed in time. 

·       Keep the records of the meetings, including declarations and minutes. 

HOW TO APPLY (INSTRUCTIONS TO APPLICANTS): 

·       Interested candidates who meet the above-mentioned requirements should submit their application, clearly stating the position title and post reference number, together a signed cover letter, detailed Curriculum Vitae (CV) containing the names and email addresses of three (3) referees, copies of qualifications (including matric) and a copy Identity Document. 

·       ONLY shortlisted candidates will be required to submit certified copies of qualifications and other related documents on or before the day of the interview, following communication from Human Resources Unit. 

·       Should you have a foreign qualification, your application must be accompanied by an evaluation certificate (report) from SAQA. 

·       Incomplete applications or applications without the aforementioned documents or information will not be considered. 

·       No late applications will be accepted. Any submissions received after the specified date and time will not be considered. 

·       Due to the larger number of responses anticipated, communication will be limited to short-listed candidates only. Applicants who have not been contacted within three (3) months after the closing date should consider their application unsuccessful. 

·       Shortlisted candidates will be expected to attend selection interviews at a date, time, and location as specified by SAHPRA. 

·       Applicants should note that pre-suitability checks will be conducted after they have been shortlisted. Their appointment is subject to positive outcomes from these checks, which include security clearance, verification of qualifications, criminal records, credit checks, citizenship status, and work experience. 

·       SAHPRA is committed to being an equal opportunity employer. When filling vacant positions, the entity will consider the principles outlined in Section 195(1)(i) of the Constitution of the Republic of South Africa (1996), the Employment Equity Act, 55 of 1998. 

·       SAHPRA promotes equity (race, gender, and disability) in line with the numeric targets in our Employment Equity plan. We are committed to this when recruiting internally and externally, with a policy to promote from within wherever possible. Preference will be given to suitably qualified individuals from previously disadvantaged groups. 

·       People with disabilities (should indicate their disability status), males (all races) and females (Coloured and White) will be given preference.

·       SAHPRA reserves the right not to make any appointment to the advertised posts. 

·       SAHPRA adheres to the provisions of the Protection of Personal Information Act (POPIA), 4 of 2013. CVs will not be returned, as the personal information you provide will be used solely for recruitment purposes, specifically for the position or vacancy you have applied for. If your application is unsuccessful, your personal information will be retained for internal audit purposes. 

·       Applications should be submitted through the SAHPRA Website Online Portal: SAHPRA website (https://www.sahpra.org.za/vacancies) / Portal Link (https://apply.sahpra.org.za:6006/).

·       For enquiries: Please contact Ms Bafedile Rakgotho, via email at bafedile.rakgotho@sahpra.org.za.

NOTE: APPLICATIONS SUBMITTED TO THIS EMAIL ADDRESS WILL NOT BE CONSIDERED AS PART OF THE RECRUITMENT PROCESS. 

The closing date is 03 September 2026 at 16:00.