Authorised Representative for Medical Devices – South Africa Bringing Your Medical Devices to the South African Market with Confidence
To place medical devices on the South African market, non-local manufacturers must comply with regulatory requirements set by the South African Health Products Regulatory Authority (SAHPRA). This includes appointing a local Authorised Representative (AR) to act as the manufacturer’s legal liaison.
International Associates Limited (IA) can serve as your AR or assist in establishing a compliant local presence, guiding you through SAHPRA licensing, product registration, and ongoing regulatory obligations. Partnering with IA ensures your medical devices reach the South African market efficiently, safely, and in full compliance with local regulations.
Recognizing that the program’s credibility depends on ensuring objectivity, WRAP is specifically organized to be independent – both financially and in terms of governance – of the apparel industry. This starts with the make-up of its independent Board of Directors. Although the apparel industry is represented on the Board to provide insight and perspective, by charter the majority of the Board is comprised of individuals not affiliated with the industry. Further, structurally, WRAP is not set up as a membership organization (yet, despite receiving no income from dues, memberships or government grants, WRAP is financially sound, with its revenue being generated entirely through facility registration fees and training revenues).
Today, WRAP has grown to become a global leader in social compliance and a trusted independent supply chain partner for dozens of companies around the world. Its comprehensive facility-based model has made it the world’s largest independent social compliance certification program for the apparel/textile industry (according to a 2010 UNIDO Study, Making Private Standards Work For You, WRAP is the “standard most often cited” for social compliance certification in the textile sector). There are currently over 2,200 WRAP-certified facilities found throughout the world employing over 2 million workers.
The wrap Principles are based on generally accepted international workplace standards, local laws, and workplace regulations, and include the spirit or language of relevant conventions of the International Labor Organization (ILO). The Principles encompass human resources management, health and safety, environmental practices, and legal compliance including import/export and customs compliance and security standards.
International Associates Limited are accredited to the WRAP Certification Program who’s objective is to independently monitor and certify compliance with these standards, to ensure that sewn products are being produced under lawful, humane and ethical conditions. Participating facilities voluntarily commit to ensuring that their manufacturing practices will meet these standards, and further commit to passing along, on their part, the expectation that their contractors and suppliers likewise comply with these standards.
What You Need to Know: SAHPRA Regulatory Requirements
Establishment Licence & Local Authorised Representative
- Foreign manufacturers, importers or distributors must obtain a valid SAHPRA medical-device establishment licence before they can legally distribute, import, or sell devices in South Africa. SAHPRA+2SAHPRA+2
- The authorised representative must be physically resident in South Africa, acting as your local contact for SAHPRA and accountable for compliance with relevant legislation and regulations. Samed+2Trade.gov+2
Device Classification & Conformity Assessment
- Devices must be classified according to SAHPRA’s risk-based classification system (e.g. Class A, B, C, D) before registration. Medic Pro+2Operon Strategist+2
- For higher-risk devices (e.g. Class B, C, D) a conformity assessment (often involving a certification body) will generally be required to demonstrate compliance to essential safety, quality and performance requirements. lexiumconsulting.com+2SAHPRA+2
Technical Documentation, Quality Management & Compliance Evidence
- Applicants must submit full technical documentation, including device descriptions, performance data, risk assessments, labelling and packaging information, instructions for use, etc. lexiumconsulting.com+2Operon Strategist+2
- As of 2025, SAHPRA requires valid ISO 13485 certification for companies applying for or renewing medical-device establishment licences — this reflects SAHPRA’s commitment to internationally recognised Quality Management System (QMS) standards. jcauditors.com+2SAHPRA+2
Registration, Post-Market Obligations & Vigilance
- Once documentation and certification are accepted, SAHPRA registration enables the device to be legally marketed in South Africa. Operon Strategist+2SAHPRA+2
- Post-market surveillance — including reporting adverse events, recalls, product vigilance and compliance with SAHPRA’s regulatory requirements — is mandatory for all device holders. SAHPRA+1
Language, Labelling & Local Regulatory Compliance
- Labelling, packaging and instructions for use must comply with SAHPRA regulations. The local AR often plays a key role in ensuring that all materials meet South African requirements (labelling, translations, documentation, etc.).
- Any changes to manufacturing, device design, or distribution arrangements must be communicated to SAHPRA, handled via the local authorised representative.
How IA Can Help as Your South Africa Authorised Representative
By partnering with IA, you gain:
- A trusted point of contact resident in South Africa, acting on your behalf with SAHPRA.
- Support with preparing and submitting the full registration dossier, including device classification, conformity documentation, ISO 13485 evidence, technical files, labelling/IFU and other required documentation.
- Guidance navigating SAHPRA’s licensing procedures (establishment licence, renewal, local representation).
- Ongoing post-market support including vigilance reporting, regulatory updates, device changes, and compliance monitoring.
- Global consistency and assurance — leveraging IA’s international experience in regulatory compliance, certification and audits.
Next Steps — What We Need from You
To begin the process we typically require:
- A full technical file of the medical device (device description, intended purpose, risk classification, labelling/IFU draft, manufacturing data, CE / international certification if applicable).
- Evidence of QMS (ISO 13485) certification or plan for obtaining it prior to SAHPRA licence application.
- Confirmation of intended distribution/ importation route and desired South African authorised-representative arrangement.
Once received, we will assess the regulatory pathway, prepare the SAHPRA submission, and guide you through every step — from initial licence application to post-market maintenance.
WAGES, BENEFITS & COMPENSATION
All legal requirements relating to wages and benefits must be met. Wages must equal or exceed the minimum wage required by law or the prevailing industry wage, whichever is higher. In addition to compensation for regular working hours, employees must be compensated for overtime hours at the rate legally required in the country of manufacture or, in those countries where such laws do not exist, at a rate exceeding the regular hourly compensation rate.Workers have the right to compensation for a regular work week that is sufficient to meet workers’ basic needs and provide some discretionary income. Where compensation does not meet workers’ basic needs and provide some discretionary income, business partners must take appropriate actions to progressively raise employee compensation and living standards through improved wage systems, benefits, welfare programmes and other services.
WORKING HOURS
FREEDOM OF ASSOCIATION & COLLECTIVE BARGAINING
DISCIPLINARY PRACTICES
Employees must be treated with respect and dignity. No employee may be subjected to any physical, sexual, psychological or verbal harassment or abuse, or to fines or penalties as a disciplinary measure.
Business partners must publicise and enforce a non-retaliation policy that permits factory employees to express their concerns about workplace conditions directly to factory management or to adidas without fear of retribution or losing their jobs.
HEALTH & SAFETY
A safe and hygienic working environment must be provided, and occupational health and safety practices which prevent accidents and injury must be promoted. This includes protection from fire, accidents and toxic substances. Lighting, heating and ventilation systems must be adequate. Employees must have access at all times to sanitary facilities which should be adequate and clean. Business partners must have health and safety policies which are clearly communicated to employees. Where residential facilities are provided to employees, the same standards apply.
ENVIRONMENTAL REQUIREMENTS
FORCED LABOUR
CHILD LABOUR
Business partners must not employ children who are less than fifteen (15) years old, or less than the age for completing compulsory education in the country of manufacture where such age is higher than fifteen (15).
DISCRIMINATION
Business partners must not discriminate in recruitment and employment practices. Decisions about hiring, salary, benefits, training opportunities, work assignments, advancement, discipline and termination must be based solely on ability to perform the job, rather than on the basis of personal characteristics or beliefs, such as race, national origin gender, religion, age, disability, marital status, parental status, association membership, sexual orientation or political opinion. Additionally, business partners must implement effective measures to protect migrant employees against any form of discrimination and to provide appropriate support services that reflect their special status.