對于泰國醫(yī)療器械注冊產品來說，了解泰國醫(yī)療器械分類規(guī)則及產品在泰國是否屬于醫(yī)療器械，屬于幾類醫(yī)療器械是前期重點事項之一。泰國醫(yī)療器械分類與我國清單制、FDA分類數據庫差異較大，而是采用了歐盟的分類規(guī)則判定模式，一起來看具體內容。
對于泰國醫(yī)療器械注冊產品來說，了解泰國醫(yī)療器械分類規(guī)則及產品在泰國是否屬于醫(yī)療器械，屬于幾類醫(yī)療器械是前期重點事項之一。泰國醫(yī)療器械分類與我國清單制、FDA分類數據庫差異較大，而是采用了歐盟的分類規(guī)則判定模式，一起來看具體內容。
泰國醫(yī)療器械注冊知識之泰國醫(yī)療器械分類
根據泰國醫(yī)療器械分類法規(guī)：Risk classification of medical devices, B.E. 2562 (2019)，
Clause 1. Medical devices shall be classified into 2 classes:
條款1. 醫(yī)療器械應分為兩類：
(1) in vitro diagnostic medical devices;
（1）體外診斷醫(yī)療器械；
(2) non-in vitro diagnostic medical devices
（2）非體外診斷醫(yī)療器械
并且進一步將體外診斷器械和非體外診斷器械依據風險登記分為四個級別，1級風險最低、2級、3級次之，4級風險最高。具體如下：
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:
條款2. 體外診斷醫(yī)療設備應根據個體和公共健康風險的級別從低到高進行分類，具體如下：
(1) type 1 medical device means a medical device with low individual and
public health risks;
(1) 類型1醫(yī)療設備指的是具有低個體和公共健康風險的醫(yī)療設備；
(2) type 2 medical device means a medical device with a moderate individual
risk or a low public health risk;
(2) 類型2醫(yī)療設備指的是具有中等個體風險或低公共健康風險的醫(yī)療設備；
(3) type 3 medical device means a medical device with a high individual risk
or a moderate public health risk;
(3) 類型3醫(yī)療設備指的是具有高個體風險或中等公共健康風險的醫(yī)療設備；
(4) type 4 medical device means a medical device with high individual and
public health risks
(4) 類型4醫(yī)療設備指的是具有高個體和公共健康風險的醫(yī)療設備。
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條 非體外診斷醫(yī)療器械應根據可能引起的風險程度從低到高進行分類，如下所示：
(1) type 1 medical device means a medical device with a low risk;
(1) 第一類醫(yī)療器械指低風險醫(yī)療器械；
(2) type 2 medical device means a medical device with a low-moderate risk;
(2) 第二類醫(yī)療器械指低-中等風險醫(yī)療器械；
(3) type 3 medical device means a medical device with a moderate-high risk;
(3) 第三類醫(yī)療器械指中等-高風險醫(yī)療器械；
(4) type 4 medical device means a medical device with a high risk.
(4) 第四類醫(yī)療器械指高風險醫(yī)療器械。
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.
非體外診斷醫(yī)療器械的風險水平分類應符合本通知附件2。
如有泰國醫(yī)療器械注冊或是泰國醫(yī)療器械分類判定服務需求，歡迎您隨時方便與杭州證標客醫(yī)藥技術咨詢有限公司聯(lián)絡，聯(lián)系人：呂工，電話：18058734169，微信同。