COFEPRIS
墨西哥联邦卫生风险防护委员会
Mexico
Last reviewed 2026-06-21
COFEPRIS根据《通用卫生法》监管墨西哥医疗器械。墨西哥使用三级分类（I、II、III）。已获FDA或EU批准的器械有互认路径。
器械分类
Class I, II, III
审批路径
COFEPRIS sanitary registration
核心监管职能
- ▸卫生注册
- ▸FDA/EU互认路径
- ▸GMP合规
- ▸进口许可
- ▸警戒报告
§ FAQ
What is COFEPRIS medical device registration?
COFEPRIS (Federal Commission for Protection against Health Risks) manages medical device registration in Mexico through a sanitary registration (registro sanitario) system. Class II and III devices require formal registration. Mexico offers expedited pathways for devices already approved by FDA, EU, or other reference authorities through mutual recognition agreements.
What is the COFEPRIS device classification system?
Mexico uses a three-class system: Class I (lowest risk), Class II (moderate risk, requires sanitary registration), and Class III (highest risk, requires sanitary registration with additional clinical evidence). Classification is determined by the General Health Council and aligns broadly with international standards.
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