對于泰國醫(yī)療器械注冊人來說，了解術語和定義非常重要，比如輔助設備、制造、標簽、廣告等。術語和定義界定了范圍、事項和邊界，將幫助我們更好的厘清事項，掌握要點?？紤]到重要的術語和定義相對較多，我將分兩個文章來說明，一起看正文。

泰國醫(yī)療器械注冊之幾個重要的術語和定義（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; 

“輔助設備”是指制造商或所有者專門打算與醫(yī)療器械一起使用的物品、器具或產(chǎn)品，以促進或使該醫(yī)療器械可用于其預期目的;

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

“制造”是指制造、組裝、發(fā)明、分案重新包裝、組合重新包裝、改進、改造、修改或消毒的行為;

 “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”是指為貿(mào)易目的而分配、供應、給予、交換、出借、授予租賃、以租購方式授予租賃或將權利或占有轉讓給他人的行為，還應包括為出售而占有的行為;

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

“進口”是指將或命令帶入王國的行為;

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

“出口”是指將王國帶出或送出王國的行為;

 “l(fā)abel” means any statement displayed on a medical device or the container or packaging thereof; 

“標簽”是指顯示在醫(yī)療器械或其容器或包裝上的任何聲明;

 “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; 

“醫(yī)療器械文檔”是指插入或封裝在此類醫(yī)療器械的容器或包裝中的紙張或任何其他能夠通過與醫(yī)療器械有關的任何聲明來表達含義的任何其他物體，還應包括使用此類醫(yī)療器械的手冊;

 “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; 

“陳述”包括通過文字、數(shù)字、人工標記、圖像、電影、燈光、聲音或標記引起外觀的行為，或任何使一般人能夠理解其含義的行為;

 “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;

“廣告” 指為貿(mào)易目的而以任何方法使公眾看到、聽到或知道某項陳述的行為，也應包括促銷行為;

如有泰國醫(yī)療器械注冊或是ISO13485認證咨詢服務需求，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。