在医疗器械产品合法引入泰国市场之前,需要在Thai FDA进行注册。当地的主要法规为Medical Device Act B.E. 2551 (2008)和Medical Device Act (2nd Edition) B.E. 2562 (2019) 等。另外作为东盟ASEAN成员国,泰国也会参考东盟相关法规。境外制造商首先需要在泰国指定授权当地代理人。注册证有效期为5年,会颁发给该...
最后,泰国食品药品监督管理局(Thai FDA)根据医疗器械的风险等级实施不同的监管措施。对于风险最低的Class 1类产品,制造商仅需要将其列入注册列表中即可。而对于风险较高的Class 2和Class 3类产品,则需要向泰国FDA提交通知,并等待其审核。对于风险最高的Class 4类产品,制造商则必须获得泰国FDA的批准许可,才能...
必应词典为您提供thai-fda的释义,网络释义: 泰国食品药物管理局;泰国食品药品管理局办公室;
In order to import pharmaceuticals, food, food supplements, cosmetics products for animal health, or other medical, narcotic and toxic substances, registration with the Food and Drug Administration (FDA) of Thailand must be applied for. Drug Registration Process Thailand A license from the Thai ...
Medical devices in Thailand are regulated by a specialized division in the Thai FDA. Medical devices will require either licensing or registration. The Thai FDA groups medical devices into 3 classes’ sub-categories as follows: Class 1 medical device: condoms, surgical gloves, syringes and diagnosti...
Regulatory services and license holding in Thailand for investors and foreign companies. Thai FDA registration, MLM license, fulfillment
ThaiFDA is currently in a transition phase from policy-based classification to risk-based classification of medical devices.Currently, medical devices are classified according to the level of risk that may cause harm or impact on public health. Policy based classification comprises of Class I (Licens...
Im勉强支付模子,因为它是昂贵的。 Im说服了卖主一定得到它从某处中国[translate] a.Thai FDA need CFS stamp from you . 泰国粮食与药物管理局需要CFS邮票从您[translate]
2.Thai FDA need real certificate add as below from your company by not stamp .5个回答 2.Thai FDA需要真正的证书,如下添加您的公司通过不戳。2013-05-23 12:21:38 回答:匿名 2.Thai粮食与药物管理局需要真正的证明增加作为下面从您的公司由不是邮票。 2013-05-23 12:23:18 回答:匿名...
The Thai FDA Quality Award evaluation is organized by the Thai Food and Drug Administration of the Ministry of Public Health, to recognize outstanding enterprises that produce pro-health products, comply with business ethics, fulfill corporate social responsibilities, and promote public health in the ...