principles to More risk-appropriate approach. decisions by the Regulatory scrutiny risk-proportionate. regulator (none at More effective risk management (regulator optimises present). resources across the spectrum of its responsibilities). Scope Medical devices all medical Impact will depend on regulatory approach. devices within Development and ongoing operational for regime. regulator. More information required on numbers and types and risk profiles. Significant transition possible. Likely large number of products affected / low to high compliance costs per product (depending on risk / complexity the majority of products by value are at – the low end). Cell and tissue Bring all CTT As above with respect to approach, costs, information therapies (CTT) within regime for required, and transition. first time. Likely very small number of products affected / low to high compliance costs per product. All hybrids, all Clarifies how such Similar to CTT above. other products products will be Few products now, but growing. defined as regulated. More customisation of regulatory approach possible. therapeutic products Powers Decisions on all Significant devolution of all powers for product and product approvals licensing decisions from Minister to regulator. and activity control Minister retains powers in relation to policy to be taken by issues, some committee appointments, and issues regulator, and where major ethical or public interest issues involved. ability to set Minister oversees regulator’s overall performance. regulatory Regulator flexibility to manage risk, subject to requirements. robust accountability (including appeal). More timely and less costly decision making. Greater conformity with public sector legislative and regulatory design standards / requirements. Reduced risk of perceived lack of political independence in decision making. Institutional form It is not yet clear The main alternatives are business unit within Ministry what if any (status quo), departmental agency, or Crown entity. changes to the institutional form of This will be subject to further reporting in 2016. the regulator are preferred. Accountability Updated Additional financial and performance reporting be organisational expected. accountability for This be aligned with the regulator’s expanded regulator. role. Updated The costs of change in accountability structures are review/appeal expected to be small and managed within baseline committees budgets. structure. New committee structure necessary in response to the devolution of powers. Review and quality control would continue to be robust.
principles to decisions by the regulator (none at present). More risk-appropriate approach. Regulatory scrutiny risk-proportionate. More effective risk management (regulator optimises resources across the spectrum of its responsibilities). Scope Medical devices Cell and tissue therapies (CTT) All hybrids, all other products defined as therapeutic products all medical devices within regime. Bring all CTT within regime for first time. Clarifies how such products will be regulated. Impact will depend on regulatory approach. Development and ongoing operational for regulator. More information required on numbers and types and risk profiles. Significant transition possible. Likely large number of products affected / low to high compliance costs per product (depending on risk / complexity – the majority of products by value are at the low end). As above with respect to approach, costs, information required, and transition. Likely very small number of products affected / low to high compliance costs per product. Similar to CTT above. Few products now, but growing. More customisation of regulatory approach possible. Powers Decisions on all product approvals and activity control to be taken by regulator, and ability to set regulatory requirements. Significant devolution of all powers for product and licensing decisions from Minister to regulator. Minister retains powers in relation to policy issues, some committee appointments, and issues where major ethical or public interest issues involved. Minister oversees regulator’s overall performance. Regulator flexibility to manage risk, subject to robust accountability (including appeal). More timely and less costly decision making. Greater conformity with public sector legislative and regulatory design standards / requirements. Reduced risk of perceived lack of political independence in decision making. Institutional form It is not yet clear what if any changes to the institutional form of the regulator are preferred. The main alternatives are business unit within Ministry (status quo), departmental agency, or Crown entity. This will be subject to further reporting in 2016. Accountability Updated organisational accountability for regulator. Updated review/appeal committees structure. Additional financial and performance reporting be expected. This be aligned with the regulator’s expanded role. The costs of change in accountability structures are expected to be small and managed within baseline budgets. New committee structure necessary in response to the devolution of powers. Review and quality control would continue to be robust.