South African Medical Device Regulatory Agency

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Medical Devices - SAHPRA

https://www.sahpra.org.za/medical-devices/

The medical device unit of SAHPRA regulates the licencing of medical device establishments and the registration of medical devices (In vitro diagnostics (IVDs) and non-IVD medical …

SAHPRA - South African Health Products Regulatory …

https://www.sahpra.org.za/

Champix 0,5 mg and 1,0 mg (varenicline) film coated Tablets – combo. Following Test results that indicated levels of increased N-nitroso-varenicline that exceed the Acceptable …

Clinical Research Regulation For South Africa | ClinRegs

https://clinregs.niaid.nih.gov/country/south-africa

South African Health Products Regulatory Authority As stated in the MRSA, Proc20of2017, and ZAF-9, the South African Health Products Regulatory Authority (SAHPRA) is the …

Medical device regulation in South Africa: The Medicines …

https://pubmed.ncbi.nlm.nih.gov/30004357/

The Medicines and Related Substances Amendment Act, 14 of 2015, has brought significant changes in the regulation of medical devices in South Africa. The …

South Africa Medical Device Regulations | RegDesk

https://www.regdesk.co/resource-library/south-africa/

A medical device means any instrument, appliance, material, machine, apparatus, implant or diagnostic reagent a) used or purporting to be suitable for use or …

Medical Device Registration and Approval in South Africa

https://arazygroup.com/medical-device-registration-south-africa/

South Africa Medical Device Registration - MCC Approval | LICENSALE® Medical Device Registration and Approval in South Africa General country-specific …

Regulatory Services in South Africa - Freyr Solutions

https://www.freyrsolutions.com/regulatory-services-in-south-africa

To enter South Africa, foreign medicines and medical device manufacturers must comply with the regulations formed by the South African Health Products Regulatory Authority …

South Africa Healthcare (Pharma and Medical Devices) …

https://www.globaldata.com/store/report/south-africa-healthcare-regulatory-and-reimbursement-analysis/

The South Africa pharmaceutical market size was valued at $4.6 billion in 2021. The market is projected to grow at a CAGR of more than 4% during the forecast …

Guide for Medical Device Registration in 9 …

https://operonstrategist.com/medical-device-registration/

Classification Of Medical Device In South Africa: South Africa has a risk-based classification strategy, based on the GHTF scheme. Organizations who handle Class A devices are …

Global Regulatory Authority Websites - PDA

https://www.pda.org/scientific-and-regulatory-affairs/regulatory-resources/global-regulatory-authority-websites

International Organizations and Foreign Government Agencies: Asia and the Pacific Europe Middle East. Africa America. Multinational Organizations: World Health Organization Pan …

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