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 Clear definition of terms and nomenclature is required to inform the and Unique device identifier regulations. Adherence to internationally accepted definitions, such as (UDI) 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 To assess quality, safety, performance, benefits and The assessment 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
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
DRAFT%209%20EAC%20MEDICALDEVICES-DIAGNOSTICS%20REGULATION%20PROJECT%20PROPOSAL-FINAL%20MAY%202015.docx