FDA certification | 合法醫療器材資訊網

,2017年1月17日—FDAdoesnotdeveloportestproductsbeforeapprovingthem.Instead,FDAexpertsreviewtheresultsoflaboratory,animal,andhumanclinical ...,2021年3月3日—HowtoknowifamedicaldeviceisFDA-approved,cleared,orauthorized.TheFDAdoesNOTissueregistrationcertificates.,TheFDAisresponsibleforprotectingthepublichealthbyensuringthesafety,efficacy,andsecurityofhumanandveterinarydrugs,biologicalproducts, ...,2020年8月12日—FDA'sexportcertificationprovidestheagency'sofficialattestationconcerningaproduct'sregu...

FDA Export Certificates | 合法醫療器材資訊網

Is It Really 'FDA Approved?' | 合法醫療器材資訊網

2017年1月17日 — FDA does not develop or test products before approving them. Instead, FDA experts review the results of laboratory, animal, and human clinical ... Read More

Are There "FDA Registered" or "FDA Certified" Medical ... | 合法醫療器材資訊網

2021年3月3日 — How to know if a medical device is FDA-approved, cleared, or authorized. The FDA does NOT issue registration certificates. Read More

U.S. Food and Drug Administration | 合法醫療器材資訊網

The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, ... Read More

Food Export Certificates | 合法醫療器材資訊網

2020年8月12日 — FDA's export certification provides the agency's official attestation concerning a product's regulatory or marketing status, based on ... Read More

Registration and Listing | 合法醫療器材資訊網

2020年8月30日 — How to register facilities and products, and how to update registrations. Animal and Veterinary. Domestic and foreign establishments that ... Read More

Medical Devices | 合法醫療器材資訊網

FDA regulates the sale of medical device products in the U.S. and monitors the safety ... Jun 30 - FDA recommends using only FDA-cleared or NIOSH-approved ... Read More

Training and Continuing Education | 合法醫療器材資訊網

FDA Learning Portal for Students, Academia, and Industry. Find education and resources related to FDA's regulatory, product quality, and safety ... Read More

How to Get FDA Approval | 合法醫療器材資訊網

To get FDA approval, drug manufacturers must conduct lab, animal, and human clinical testing and submit their data to FDA. FDA will then review the data and may ... Read More

相關資訊整理

FDA certification | 合法醫療器材資訊網

FDA Export Certificates | 合法醫療器材資訊網

Is It Really 'FDA Approved?' | 合法醫療器材資訊網

Are There "FDA Registered" or "FDA Certified" Medical ... | 合法醫療器材資訊網

U.S. Food and Drug Administration | 合法醫療器材資訊網

Food Export Certificates | 合法醫療器材資訊網

Registration and Listing | 合法醫療器材資訊網

Medical Devices | 合法醫療器材資訊網

Training and Continuing Education | 合法醫療器材資訊網

How to Get FDA Approval | 合法醫療器材資訊網

【"寶麗"研磨裝置及其附件 (未滅菌)】許可證字號:衛部醫器輸壹字第014569號

【"何人可" 洗鼻器 (未滅菌)】許可證字號:衛部醫器輸壹字第018131號

【“合皓”牙齒骨內植入物附件(未滅菌)】許可證字號:衛署醫器輸壹字第009765號

【"巨賈" 矯正鏡片 (未滅菌)】許可證字號:衛部醫器製壹字第006292號

【“眼力健”愛鷹視雷射屈光矯正評估工作站】許可證字號:衛部醫器輸字第032898號

【"鈦醫" 牙齒骨內植入物附件 (未滅菌)】許可證字號:衛部醫器陸輸壹字第004379號

【"優亞特"約束帶(未滅菌)】許可證字號:衛署醫器製壹字第003463號

【“彼娜波”安擎抽吸幫浦】許可證字號:衛部醫器輸字第033739號

【輸液器（美製）】許可證字號:衛署醫器輸字第000413號

【"愛瑪士" 綠光雷射系統】許可證字號:衛署醫器輸字第010501號

【亞培性傳染病檢驗套組】許可證字號:衛部醫器輸字第033527號

【“美樂迪”聲電刺激聲音處理器】許可證字號:衛署醫器輸字第021225號

【"安施" 非動力式神經外科用器械 (未滅菌)】許可證字號:衛部醫器輸壹字第014541號

【“瑞士水愛麗”玻尿酸植入物】許可證字號:衛部醫器輸字第031564號

【“好美得卡奧斯得寧”三項能局部人工膝關節系統】許可證字號:衛部醫器輸字第030018號

【"賽斯" 牙科手機及其附件(未滅菌)】許可證字號:衛署醫器輸壹字第010480號

【“都邇”放射線影片(未滅菌)】許可證字號:衛部醫器輸壹字第020871號

【舒美軟性隱形眼鏡】許可證字號:衛署醫器輸字第006003號

【3M兒童醫用口罩(未滅菌)】許可證字號:衛署醫器輸壹字第011643號

【"愛惜康" 內視鏡縫合輔助器】許可證字號:衛署醫器輸字第009509號

【"慕樂" 軀幹護具 (未滅菌)】許可證字號:衛署醫器輸壹字第002860號

【昕睫彩色二週拋式軟性隱形眼鏡】許可證字號:衛署醫器製字第002515號

【亞培輔理善越佳型醫院用血糖血酮監測儀】許可證字號:衛部醫器陸輸字第000582號

【"萬力" 搖控後荷式治療機】許可證字號:衛署醫器輸字第007480號

【"優奇"血液迴路管】許可證字號:衛署醫器輸字第012728號

【“銀谷” 醫用腰帶(未滅菌)】許可證字號:衛部醫器輸壹字第022323號

【“西門子”螺旋式電腦斷層掃描系統】許可證字號:衛署醫器輸字第022925號

【貝克曼庫爾特爾瑞 β-2-微球蛋白試劑】許可證字號:衛署醫器輸字第012209號

【“唯德康”一次性內視鏡使用注射針】許可證字號:衛部醫器陸輸字第000984號

【"晉皇" 金石型呼吸管路細菌過濾器】許可證字號:衛署醫器製字第001430號

FDA Export Certificates | 合法醫療器材資訊網

Is It Really &#39;FDA Approved?&#39; | 合法醫療器材資訊網

Are There "FDA Registered" or "FDA Certified" Medical ... | 合法醫療器材資訊網

U.S. Food and Drug Administration | 合法醫療器材資訊網

Food Export Certificates | 合法醫療器材資訊網

Registration and Listing | 合法醫療器材資訊網

Medical Devices | 合法醫療器材資訊網

Training and Continuing Education | 合法醫療器材資訊網

How to Get FDA Approval | 合法醫療器材資訊網

Is It Really 'FDA Approved?' | 合法醫療器材資訊網