South Africa Case Law

Homemed (PTY) Ltd v Claasen and Others (2022/004040)

Homemed (PTY) Ltd v Claasen and Others (2022/004040) [2022] ZAGPJHC 494 (1 August 2022)

Court

South Gauteng High Court, Johannesburg

Case number

2022/004040

Judge

Gilbert AJ

The court found that the applicant established a prima facie right to restrain ELS from distributing DOA rapid screening tests without a medical establishment licence, as the products are, at least prima facie, medical devices not falling within the Class A exclusion of the 2017 Directive. The regulatory authority (SAHPRA), the FDA, and the EU MDCG support the classification of these products as Class B medical devices. The applicant demonstrated ongoing irreparable harm and lack of adequate alternative remedy, and the balance of convenience favoured granting interim relief. The court decline…

Source excerpt

• Restraint Of Trade
• Unlawful Competition
• Medical Device Regulation
• Interim Interdict
• Confidential Information

Allergan Pharmaceuticals (Pty) Ltd v Medicines Control Council and Others (992/2015)

Allergan Pharmaceuticals (Pty) Ltd v Medicines Control Council and Others (992/2015) [2015] ZAGPPHC 319; [2015] 3 All SA 173 (GP) (5 May 2015)

Court

North Gauteng High Court, Pretoria

Case number

992/2015

Judge

Jansen

The court held that the Optive range was a medical device, not a medicine, and ordered the respondents to release detained products and pay costs.

• Medicines And Related Substances Act
• Medical Device Regulation
• Declaratory Relief
• Call Up Notice Interpretation
• Medical-device-regulation
• Medicines-and-related-substances-act