Objective Year 1 Year 2 Year 3 Responsible Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8 Q9 Q10 Q11 Q12 1 To establish and strengthen the legal and policy framework on regulation of (i) medical devices and (ii) in vitro diagnostics within each of the Partner States Assessment report of the existing policy and legal framework Policy framework Legal framework For each Partner an established regulatory body, or a business plan and timelines for establishment of a NRA, with capacity for harmonized regulation of medical devices and in vitro diagnostics.
regulation of (i) medical devices and (ii) in vitro diagnostics based on risk classification common definitions for medical devices and IVD A strategy to determine risk classification for technologies/products seeking market entry. List of EAC Partner States priority IVDs and medical devices, by type and disease and risk classification regulations, guidelines and standard operating procedures for regulation of medical devices and IVDs Recommendations for recognizing regulatory decisions of stringent NRAs or WHO Prequalification Program and process for expedited review, if appropriate.
and affordable medical devices and diagnostics though harmonized regulation. 8 To work in collaboration with the London School of Hygiene and Tropical Medicine and other partners to establish mechanisms to ensure that regulatory decisions are based on strong and clear science and that regulatory science keeps pace with technological innovation To establish a forum for collaboration, technical exchanges on new science and technologies among regulators, healthcare professional groups, academia and consumers. To foster mechanisms for harmonized assessment of new technologies and develop regulatory science in keeping with technological innovation
Corrections/Recall A by which corrections can be made and where there is a risk to public health substandard products can be removed from the market. Reference: GHTF SG2/N57R8:2006 Information Exchange Establishment of systems to ensure timely exchange in confidence, of adverse events and other aspects associated with quality, safety and performance of a medical device or diagnostic. References: GHTF/SG2/ N38R19:2009; GHTF/SG2/N9R11:2003; GHTF/SG2/N20R10:2002 Post market inspections Mechanism to inspect as required in response to a concern regarding the quality, safety and performance of a medical device or diagnostic. See references from premarket controls. Penalties Legislation should include relevant and appropriate penalties to ensure that manufacturers and suppliers comply with the regulation. Premarket controls Policy and Framework A legal framework allows national regulatory control authorities to administer and enforce the regulations. Regulations may pertain to safety, performance, quality, good manufacturing practices, labelling, advertising and other such matters deemed in the interest of public health protection. For a regulatory system to be effective it must be enforceable in both the public and private healthcare sector. Definitions, nomenclature and Unique device identifier (UDI) Clear definition of terms and nomenclature is required to inform the regulations. Adherence to internationally accepted definitions, such as those proposed by IMDRF/GHTF, and Global Medical Device Nomenclature (GMDN) advances harmonisation efforts and reduces barriers to trade. Risk Based classification Activities undertaken by or on behalf of the regulator should be proportional to the product under consideration where products are stratified according to the risk (or hazard) they pose to public or personal health according to the intended use. References: GHTF/SG1/N77:2012;GHTF/SG1/N045:2008 Premarket conformity assessment To assess quality, safety, performance, benefits and The conformity assessment activity will be determined by the risk class of the medical device or diagnostic. References: GHTF/SG1/N78:2012; GHTF/SG1/N046:2008; GHTF/SG1/N063:2011; GHTF/SG1/N011:2008