对于泰国医疗器械注册人来说，了解术语和定义非常重要，比如辅助设备、制造、标签、广告等。术语和定义界定了范围、事项和边界，将帮助我们更好的厘清事项，掌握要点。考虑到重要的术语和定义相对较多，我将分两个文章来说明，一起看正文。

泰国医疗器械注册之几个重要的术语和定义（一）

“supplementary equipment”means an article, appliance or product specifically intended by the manufacturer or owner to be used in conjunction with a medical device for facilitating or causing such medical device to be usable for the intended purpose thereof; 

“辅助设备”是指制造商或所有者专门打算与医疗器械一起使用的物品、器具或产品，以促进或使该医疗器械可用于其预期目的;

 “manufacture” means an act of making, assembling, inventing, divisional repackaging, combinational re-packaging, improving, transforming, modifying or sterilising; 

“制造”是指制造、组装、发明、分案重新包装、组合重新包装、改进、改造、修改或消毒的行为;

 “sell” means an act of distributing, supplying, giving, exchanging, lending, granting a lease, granting a lease on a hire-purchase basis or transferring rights or possession to another person, for the purpose of trade, and shall also include an act of having in possession for sale; 

“出售”是指为贸易目的而分配、供应、给予、交换、出借、授予租赁、以租购方式授予租赁或将权利或占有转让给他人的行为，还应包括为出售而占有的行为;

 “import” means an act of bringing or ordering into the Kingdom; 

“进口”是指将或命令带入王国的行为;

 “export” means an act of bringing or sending out of the Kingdom; 

“出口”是指将王国带出或送出王国的行为;

 “label” means any statement displayed on a medical device or the container or packaging thereof; 

“标签”是指显示在医疗器械或其容器或包装上的任何声明;

 “medical device documentation” means paper or any other object capable of presenting a meaning through any statement relating to a medical device, which is inserted or enclosed in the container or packaging of such medical device and shall also include a manual for using such medical device; 

“医疗器械文档”是指插入或封装在此类医疗器械的容器或包装中的纸张或任何其他能够通过与医疗器械有关的任何声明来表达含义的任何其他物体，还应包括使用此类医疗器械的手册;

 “statement” includes an act of causing an appearance through a letter, figure, artificial mark, image, cinematographic movie, light, sound or mark or any act enabling persons in general to comprehend the meaning; 

“陈述”包括通过文字、数字、人工标记、图像、电影、灯光、声音或标记引起外观的行为，或任何使一般人能够理解其含义的行为;

 “advertising” means an act, by whatever method, done with a view to causing members of the public to see, hear or know a statement, for the purpose of trade, and shall also include an act of sale promotion;

“广告” 指为贸易目的而以任何方法使公众看到、听到或知道某项陈述的行为，也应包括促销行为;

如有泰国医疗器械注册或是ISO13485认证咨询服务需求，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。