Medical Devices Regulations

Canada · Last verified: 2026-09-08

Number

SOR/98-282

Type

Regulation

Issuer

Governor in Council (Health Canada), under the Food and Drugs Act

Status

in_force

Authority

Health Canada

What this covers

加拿大医疗器械核心条例，依《食品药品法》制定。规定器械 I–IV 类分级规则、安全与有效性要求、标签、器械许可（licence）与企业许可（establishment licence）、事故报告、召回与植入物登记。现行合并版本更新至 2026-06-17。

Source: e-Gov Law Search, Japan