Your Trusted Regulatory Partner For Success in South Africa
- Team of Industry Experts
- Expertise in Regulatory Submissions
- Clear and Effective Communication with Client
South Africa
Entering the South African market as a foreign manufacturer of medicines and medical devices requires adherence to regulations set forth by the South African Health Products Regulatory Authority (SAHPRA), formerly known as MCC. Recent legislation has established SAHPRA as the new regulatory agency overseeing drugs, biologics, medical devices, in vitro diagnostics, complementary medicinal products, food, and cosmetics. This transition may present procedural challenges for manufacturers seeking registrations and approvals.
At MedWisdom Life Science Company, we understand the complexities and uncertainties surrounding regulatory transitions in South Africa. We offer comprehensive regulatory services that encompass strategic advice, regulatory intelligence, and hands-on support throughout the entire regulatory process.
Medwisdom Lifescience Offerings in South Africa
Pharmaceuticals | Medical Devices | Cosmetics |
SAHPRA Drug Registration | SAHPRA Medical Device Registration | SAHPRA Cosmetic Product Registration |
Clinical Trial Applications (CTA) | Clinical Evaluation and Performance Studies | Safety and Efficacy Assessments |
Product Registration Amendments | Quality Management System (QMS) Audits | Labelling Compliance |
Pharmacovigilance and Drug Safety | Risk Management and ISO 13485 Compliance | Advertising Compliance |
GMP Compliance | Technical File Preparation and Submission | Import and Export Services |
Pharmacy Licensing | Labelling and Instructions for Use Compliance | Compliance with Prohibited Substances |