COFEPRIS
墨西哥聯邦衛生風險防護委員會
Mexico
Last reviewed 2026-06-21
COFEPRIS根據《通用衛生法》監管墨西哥醫療器材。墨西哥使用三級分類（I、II、III）。已獲FDA或EU批准的器材有互認路徑。
器材分類
Class I, II, III
審批路徑
COFEPRIS sanitary registration
核心監管職能
- ▸衛生註冊
- ▸FDA/EU互認路徑
- ▸GMP合規
- ▸進口許可
- ▸警戒報告
§ 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.
MedFlux即時監控COFEPRIS的監管變化、安全警報和市場信號——讓您的團隊不錯過任何關鍵更新。
免費監控{abbr} →