Workshop on Good Regulatory and its implementation in the Medical Device Sector

The COVID-19 Medical Device Regulatory Convergence Project (MDRC) together with South Africa and Kenya Medical Device Authorities will hold on 31 January and February 1st the Workshop on Good Regulatory Practices and its implementation in the Medical Device Sector according to the agenda below.

The event will be held in English with simultaneous interpretation to Portuguese and French.

For registration to participate, please click here.

Agenda

“Good Regulatory Practices and its implementation in the Medical Devices Sector”

The COVID-19 Medical Device Regulatory Convergence Project (MDRC) and the South African Health Products Regulatory Authority (SAHPRA) held two Sessions on Good Regulatory Practices and Its Implementation in the Medical Device Sector, which took place on 10 and 11 August 2022.

These training sessions intended to promote, through the exchange of experiences, the utilization of Good Regulatory Practices in the process to implement international standards with regulatory purposes for Medical Devices.

Agenda

Session I

Recording

Presentations

Introduction and Overview on Good Regulatory Practices (GRP) – Renata Amaral, MDRC

International Benchmarks for Medical Device Regulatory Frameworks and Authorities:

Health References & Recommendations: Good Regulatory Practices and Good Reliance Practices – Agnes Sitta Kijo, WHO

International Benchmarks for Medical Device Regulatory Frameworks and Authorities: Health References & Recommendations – Khanyisile Nkuku, SAHPRA

Trade & Legal References and Obligations:

TBT Agreement and medical devices – Lauro Locks, WTO

Session II

Recording

Presentations

South African Legislative & Regulatory Framework for Medical Devices – Current Situation and Roadmap for the future:

Medical Device Regulations Status – Lydia Motlogelwa, SAHPRA

Review of South African Medical Device Technical Standardization & Stakeholder Participation:

Standards Development Process, Phollen Murivhula, SABS