對于泰國醫(yī)療器械注冊產(chǎn)品來說，了解泰國醫(yī)療器械分類規(guī)則及產(chǎn)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(shù)據(jù)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(nèi)容。
對于泰國醫(yī)療器械注冊產(chǎn)品來說，了解泰國醫(yī)療器械分類規(guī)則及產(chǎn)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(shù)據(jù)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(nèi)容。
泰國醫(yī)療器械注冊知識之泰國醫(yī)療器械分類
根據(jù)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(yīng)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(jù)風(fēng)險登記分為四個級別，1級風(fēng)險最低、2級、3級次之，4級風(fēng)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(shè)備應(yīng)根據(jù)個體和公共健康風(fēng)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(shè)備指的是具有低個體和公共健康風(fēng)險的醫(yī)療設(shè)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(shè)備指的是具有中等個體風(fēng)險或低公共健康風(fēng)險的醫(yī)療設(shè)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(shè)備指的是具有高個體風(fēng)險或中等公共健康風(fēng)險的醫(yī)療設(shè)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(shè)備指的是具有高個體和公共健康風(fēng)險的醫(yī)療設(shè)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(yīng)根據(jù)可能引起的風(fēng)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(fēng)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(fēng)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(fēng)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(fēng)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(fēng)險水平分類應(yīng)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(wù)需求，歡迎您隨時方便與杭州證標客醫(yī)藥技術(shù)咨詢有限公司聯(lián)絡(luò)，聯(lián)系人：呂工，電話：18058734169，微信同。