对于泰国医疗器械注册产品来说，了解泰国医疗器械分类规则及产品在泰国是否属于医疗器械，属于几类医疗器械是前期重点事项之一。泰国医疗器械分类与我国清单制、FDA分类数据库差异较大，而是采用了欧盟的分类规则判定模式，一起来看具体内容。

泰国医疗器械注册知识之泰国医疗器械分类

根据泰国医疗器械分类法规：Risk classification of medical devices, B.E. 2562 (2019)，

Clause 1. Medical devices shall be classified into 2 classes:

条款1. 医疗器械应分为两类：

 (1) in vitro diagnostic medical devices; 

（1）体外诊断医疗器械；

(2) non-in vitro diagnostic medical devices

（2）非体外诊断医疗器械

并且进一步将体外诊断器械和非体外诊断器械依据风险登记分为四个级别，1级风险最低、2级、3级次之，4级风险最高。具体如下：

Clause 2. In vitro diagnostic medical devices shall be classified according to the level of individual and public health risks from low to high levels as follows: 

条款2. 体外诊断医疗设备应根据个体和公共健康风险的级别从低到高进行分类，具体如下：

(1) type 1 medical device means a medical device with low individual and public health risks; 

(1) 类型1医疗设备指的是具有低个体和公共健康风险的医疗设备；

(2) type 2 medical device means a medical device with a moderate individual risk or a low public health risk; 

(2) 类型2医疗设备指的是具有中等个体风险或低公共健康风险的医疗设备；

(3) type 3 medical device means a medical device with a high individual risk or a moderate public health risk; 

(3) 类型3医疗设备指的是具有高个体风险或中等公共健康风险的医疗设备；

(4) type 4 medical device means a medical device with high individual and public health risks

(4) 类型4医疗设备指的是具有高个体和公共健康风险的医疗设备。

Clause 3. Non-in vitro diagnostic medical devices shall be classified according to the level of risks that may be caused from low to high levels as follows:

第3条 非体外诊断医疗器械应根据可能引起的风险程度从低到高进行分类，如下所示： 

(1) type 1 medical device means a medical device with a low risk;

(1) 第一类医疗器械指低风险医疗器械；

(2) type 2 medical device means a medical device with a low-moderate risk;

(2) 第二类医疗器械指低-中等风险医疗器械；

(3) type 3 medical device means a medical device with a moderate-high risk;

(3) 第三类医疗器械指中等-高风险医疗器械；

(4) type 4 medical device means a medical device with a high risk.

(4) 第四类医疗器械指高风险医疗器械。 

The classification of non-in vitro diagnostic medical devices according to the level of risks shall be in accordance with Document No. 2 annexed to this Notification.

非体外诊断医疗器械的风险水平分类应符合本通知附件2。

如有泰国医疗器械注册或是泰国医疗器械分类判定服务需求，欢迎您随时方便与杭州证标客医药技术咨询有限公司联络，联系人：吕工，电话：18058734169，微信同。