§ COMPARE REGULATORS
MHRA vs Medsafe：医疗器械监管对比
对比 MHRA (United Kingdom) 与 Medsafe (New Zealand) 的医疗器械注册路径、分类和监管要求。
MHRA
英国药品和医疗产品监管局
United Kingdom
脱欧后，MHRA在英国运营独立的医疗器械监管框架。英国合格评定（UKCA）标志正在取代CE标志。MHRA正在开发与EU MDR不同的独立器械法规框架。…
CLASSES
Class I, IIa, IIb, III
PATHWAY
UKCA marking via UK Approved Body
KEY FUNCTIONS
- ▸UKCA标志
- ▸英国器械注册
- ▸Yellow Card不良事件报告
- ▸英国批准机构监管
Medsafe
Medsafe — New Zealand医疗器械监管机构
New Zealand
Medsafe是New Zealand负责医疗器械监管的国家监管机构，负责器械注册、市场监督和不良事件报告。…
CLASSES
Class I, IIa, IIb, III
PATHWAY
Medsafe registration
KEY FUNCTIONS
- ▸器械注册
- ▸市场监督
- ▸不良事件报告
- ▸进出口管控
MedFlux monitors both MHRA and Medsafe in real time — every regulatory change, safety alert, and market signal delivered in under 90 seconds.
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