對于泰國醫療器械注冊人來說，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。考慮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。
對于泰國醫療器械注冊人來說，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。考慮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療器械一起使用的物品、器具或產品，以促進或使該醫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;
“label” means any statement displayed on a medical device or the container or
packaging thereof;
“標簽”是指顯示在醫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;
“醫療器械文檔”是指插入或封裝在此類醫療器械的容器或包裝中的紙張或任何其他能夠通過與醫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藥技術咨詢有限公司聯絡，聯系人：呂工，電話：18058734169，微信同。