馬來西亞醫療器材分類：基於風險的系統和東盟指令協調

For Rule 11 of MDA/GD/0009 - Rules of Classification for General Medical Devices, the classification hinges on whether the monitoring is for "Vital Physiological Parameters" where a variation could result in immediate danger. For general home wellness, Class B is possible. However, if the device is intended for Post-Operative Monitoring where clinicians make immediate life-saving interventions based on the data, the MDA classifies this as Class C. Since your device covers both scenarios, you must register it as Class C to legally cover the hospital-use claim.

In Malaysia, the "Intended Use" is the primary driver. Under MD-GD0001 Rule 3, most cancer screening IVDs are Class C. However, if the MDA determines that the test is intended for screening blood, tissues, or organs for high-risk infectious agents (even if secondary), or if the failure of the screening has a massive public health impact (similar to Rule 1 for HIV/Hepatitis), it may escalate to Class D. For cancer markers, they usually stay in Class C, but your Clinical Evidence Report (CER) must prove that the "Population Screening" claim does not lead to unacceptable rates of false negatives for this fatal disease.

确切如此。根据 东盟法规Rule 13，任何含有药用物质且该物质对器械功能起辅助作用的产品，一律归为最高风险等级 Class D。即便该药物含量极低，只要具备生物活性，分类就会升级。如果该药物未在 NPRA 注册，MDA 会要求进行“会审（Joint Consultation）”，这通常会将总审批周期延长 6-12 个月，因为需要额外评估药物部分的安全性。

是的。在马来西亚，分组（Grouping）中的风险等级由最高等级的组件决定。MDA/GD-04 Rule 9 规定，如果能量释放的强度或方式可能对人体造成显著伤害（如激光手术属于 Class C），则整个注册项必须按照 Class C 进行申报。这意味着您可能需要通过合格评定机构 (CAB) 的完整技术文件审核（Full Audit），而不能走 B 类的简化审计路径。