Help us improve Public Health in Africa.

Falsified and substandard medicines threaten recent improvements to global public health–particularly in Africa. USP and its collaborators work across the region to ensure quality medicines availability. Join us in helping our partners develop skills needed to deliver quality assured medicines to citizens who need them most.

USP Ghana provides courses featuring lectures from working professionals in key sectors. We are currently recruiting experts to teach Medical Devices Course.

Successful applicant should demonstrate ability to teach below topics of interest and examine training candidates;

• Landscape of regulation of IVD Medical Devices (Global approaches)

• IMDRF (GHTF)/Harmonization
• AHWP
• PAHWP
• ALLADIV
• WHO

• Definition of a medical device and regulating medical devices

• Law
• Regulations/Guidelines
• Regulatory Authority/ Role
• Key stakeholders (Government and Non-Government Institutions)

• Elements and mechanisms for regulatory oversight

• Pre market controls
• Post market controls

• Key principles in establishing medical devices safety and performance

• Risk classification (Classification Rules)
• ISO Standards
• Global Medical Device Nomenclature (GMDN)
• UDI
• QMS (ISO 13485)
• Clinical Performance Studies
• Post Marketing surveillance

• Introduction to GHTF Guidelines for assessment of Technical files

• Content of Medical Devices Technical Documentation
• Medical devices exempted from registration (listing)
• Fees
• Abridged /Full assessment of Technical files (Dossier)
• CSDT (Common Submission Dossier Template) GHTF
• STED (Summary Technical Documentation)
• Renewal, alterations
• Labelling requirements

• Review of Information Provided to a Regulatory Authority

• Assessment of documentation submitted for marketing authorization purposes

Required Skills or Experience

• Applicant must have a minimum of Bachelor/Master’s degree in Pharmacy, Biomedical Sciences/Engineering or pharmaceutical sciences
• Not less than 10 years’ experience in the regulation of medicines (5 years in the area of medical devices)
• Applicant should demonstrate ability and skills to teach above identified topics relating to Medical Devices.
• Particular consideration will be given to current National regulators, Pharmaceutical manufacturers, and international supply chain consultants