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What we aim for:The aim of HPRC is to ensure that all medical companies in South
Africa are compliant with the regulators within the medical industryGet in touch -
Our services:Read MoreProduct RegistrationAssistance with ISO accreditationCompany Licence RegistrationGuidance with registration and marketingAdvice on all regulatory frame work
Vision
HPRC envisions that all health products trading on the South African market are safe and affordable to citizens of the Republic.
Our Goal
The aim of HPRC is to ensure that all medical companies in South Africa are compliant with the regulators within the medical industry.
Welcome to Health Products Regulatory Consulting
The Department of Health, Radiation Control (Department of Health) and the South African Health Products Regulatory Authority publishes various regulations and amendments to the Medicines and Related Substance Act, No. 101 of 1965 (as amended) which requires compliance from companies in South Africa. In order for all medical/ pharmaceutical companies to trade legally and appropriately in the Republic of South Africa, they are required to attain certifications and accreditations from various statutory bodies.
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Frequently Asked Questions
These are just some of the regular questions we get. For more info please contact us.
FAQs
If you manufacture, import, export, distribute or wholesale medical devices you must be regulated as per the regulations in South Africa
You will be required to attain a licence, undergo inspections and have compliance standards implemented in your company. HPRC will assist you will all the documentation and provide guidance on compliance for pharmaceuticals for sale in South Africa
You will be required to comply to pharmaceutical practices (GMP, GWP, GCP) as well as other regulatory standards set out by the regulator. For medical devices you will be required to comply to ISO 13485:2016 and good wholesaling practices.
All medical device establishments must have an authorized representative whom is a natural legal person that is responsible for the medical device on the market. This person must have knowledge of the devices and should be held accountable for the device in the country. It is not a necessity that the appointed authorized representative is a qualified pharmacist.
The South African Health Products Regulatory Authority has a pharmacovigilance unit in which there is an oversight of all reporting of adverse events incidents. The recommended documents must be completed and submitted upon notification of the adverse event incident.
Book an appointment
Please call +27 79 872 1793 if urgent. Or get in touch by filling in the form below, and will get back to you as soon as possible, and ensure that you receive the best possible service.