Choose a Mexico Registration Holder (MRH) 常见问题 - 更新 October 2025
How To 选择MRH的7个关键标准. Pure Global 法规专家提供的专业指导
Pure Global将法规专业知识与AI驱动工具相结合,简化COFEPRIS注册流程。我们的独立MRH服务确保您完全掌控注册,同时在分类、档案编制和新简化途径方面获得专家指导,实现更快批准。
Published rates: LR $1K-$2K, Class I $3K-$4K, Class II/III $5K-$7K
Leverage existing FDA/EU approvals for 30-day COFEPRIS review times
Not affiliated with distributors - you control your registrations
30+ countries, local Mexico office, Spanish/English fluency
医疗器械市场总规模(2024年)
2024-2029年预期增长率
COFEPRIS审查(简化途径vs标准途径)
续期费用为原始费用的50%
常见问题
理解墨西哥注册持有人(MRH)要求
评估MRH定价和透明度
COFEPRIS途径和时间表
MRH选择标准和尽职调查
Low Risk (LR)
$1,000 - $2,000
Class I Devices
$3,000 - $4,000
Class II/III Devices
$5,000 - $7,000
Includes:
- ✓ Classification verification
- ✓ Spanish translation
- ✓ COFEPRIS submission
- ✓ Query response management
Essential Criteria:
- ☐ Published pricing transparency
- ☐ Local Mexico office presence
- ☐ Independent (not distributor)
- ☐ 5+ years COFEPRIS experience
- ☐ Spanish/English fluency
- ☐ Abbreviated Pathway expertise
- ☐ Client references available
✅ Pure Global meets all criteria
注意： 本常见问题指南提供有关法规要求的一般信息，不应被视为法律建议。法规可能会发生变化。请始终咨询合格的法规专业人士以获取具体指导。
Last updated: October 2025 | Based on Choose a Mexico Registration Holder (MRH) official documentation