Registration and Listing | 合法醫療器材資訊網

2020年8月30日—Howtoregisterfacilitiesandproducts,andhowtoupdateregistrations.AnimalandVeterinary.Domesticandforeignestablishmentsthat ...

How to register facilities and products, and how to update registrations Animal and Veterinary

Domestic and foreign establishments that manufacture, repack, or re-label animal drug products in the United States are required to register with the FDA. Domestic and foreign drug manufacturers, repackers or re-labelers are also required to list all of their commercially marketed drug products. This process is done in conjunction with the human drug registration process.

Cosmetics

The Voluntary Cosmetic Registration Program (VCRP) is an FDA post-market reporting system for use by manufacturers, packers, and distributors of cosmetic products that are in commercial distribution in the United States.

Drugs

Domestic and foreign establishments that manufacture, repack, or re-label drug products in the Unit...

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

Registration and Listing | 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

【“通德”遠紅外線彈性繃帶(未滅菌)】許可證字號:衛署醫器製壹字第003560號

【“達克” PD-L1免疫組織化學染色22C3檢測套組】許可證字號:衛部醫器輸字第028961號

【“秀山莊”肢體護具 (未滅菌)】許可證字號:衛署醫器製壹字第001930號

【"白雲藍天"耳鼻喉佈施藥裝置(未滅菌)】許可證字號:衛署醫器陸輸壹字第001341號

【“恆隆行”軀幹裝具 (未滅菌)】許可證字號:衛署醫器製壹字第002652號

【"壹誠"一般手術用手動式器械(滅菌)】許可證字號:衛部醫器製壹字第005207號

【“克洛瑪”菲瑞斯公主玻尿酸】許可證字號:衛部醫器輸字第026879號

【"鈦醫" 牙齒骨內植入物附件 (未滅菌)】許可證字號:衛部醫器製壹字第006794號

【"邁克奇" 沙門氏菌抗血清試劑（未滅菌）】許可證字號:衛部醫器輸壹字第020378號

【"720 CRX" 矯正鏡片 (未滅菌)】許可證字號:衛部醫器製壹字第006822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

【羅氏抗PD-L1 (SP142) 兔單株一級抗體檢驗試劑】許可證字號:衛部醫器輸字第033118號

【"里凡諾瓦" 心肺血管繞道術輔助設備 (未滅菌)】許可證字號:衛部醫器輸壹字第016756號

【"雅氏"腰椎人工椎間盤】許可證字號:衛署醫器輸字第017432號

【“可立耳”巴哈系統】許可證字號:衛署醫器輸字第018132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