Medical Devices Regulations — PART 2: Custom-Made Devices and Medical Devices to Be Imported or Sold for Special Access

Canada · Last verified: 2026-09-08

Number
SOR/98-282, PART 2
Type
Regulation
Issuer
Governor in Council (Health Canada)
Status
in_force
Authority
Health Canada

What this covers

第 2 部分。定制器械与特殊准入(special access)进口/销售器械的授权条件、标签、经销记录、事故报告与植入物登记要求。

Official text: https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/page-1.html

Source: e-Gov Law Search, Japan

Facts only; not legal advice. The official current text prevails.