Medical Devices Regulations — PART 1: General

Canada · Last verified: 2026-09-08

Number

SOR/98-282, PART 1

Type

Regulation

Issuer

Governor in Council (Health Canada)

Status

in_force

Authority

Health Canada

What this covers

第 1 部分（总则）。医疗器械条例的主体：制造商义务、安全与有效性要求、标签要求、I 类器械与 II/III/IV 类器械的许可要求、企业许可、经销记录、投诉处理、事故报告、短缺与召回、植入物登记。

Source: e-Gov Law Search, Japan