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

【"居霹" 手術用器具馬達與配件或附件 (未滅菌)】許可證字號:衛署醫器輸壹字第012656號

【“富爾彬”外科手術用攝影機 (未滅菌)】許可證字號:衛部醫器輸壹字第013911號

【“波士頓科技”安博倫程式設定裝置】許可證字號:衛部醫器輸字第029112號

【“亞培”第二代二尖瓣夾合器夾子導管輸送系統】許可證字號:衛部醫器輸字第029770號

【人工耳蝸植入系統】許可證字號:衛署醫器輸字第006954號

【閏爵氣球擴張導管】許可證字號:衛署醫器輸字第008462號

【“波士頓科技” 綠光雷射系統】許可證字號:衛部醫器輸字第033720號

【美樂迪人工電子耳】許可證字號:衛署醫器輸字第018541號

【"帝寶" 助聽器 (未滅菌)】許可證字號:衛部醫器陸輸壹字第002015號

【“法斯樂舒順”蘭斯頓雙腔導管】許可證字號:衛署醫器輸字第023106號

【“波士頓科技”綠光雷射光纖】許可證字號:衛署醫器輸字第022964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

【"得禎" 減壓坐墊 (未滅菌)】許可證字號:衛部醫器陸輸壹字第003227號

【"倍達樂" 交流電力可調整式病床 (未滅菌)】許可證字號:衛部醫器輸壹字第022290號

【“佳世達” 光學取模系統應用軟體 (未滅菌)】許可證字號:衛部醫器陸輸壹字第004148號

【"碧雅思" 牙科手機及其附件 (未滅菌)】許可證字號:衛部醫器輸壹字第021050號

【三通聯板　〝雅客〞】許可證字號:衛署醫器輸字第008527號

【康復特波經皮神經電刺激器及生物阻抗分析儀】許可證字號:衛部醫器製字第007070號

【“新廣業”氣體面罩頭套帶(未滅菌)】許可證字號:衛部醫器陸輸壹字第003838號

【羅氏多電極凝集分析二磷酸腺苷檢驗試劑】許可證字號:衛部醫器輸字第025543號

【“邁瑞”可攜式彩色都卜勒超音波系統】許可證字號:衛部醫器陸輸字第000736號

【“博美敦”歐菲菈迷你懸吊帶系統】許可證字號:衛部醫器輸字第025630號

【"諧泰"軀幹裝具(未滅菌)】許可證字號:衛署醫器陸輸壹字第001452號

【德賽正常值複合品管液】許可證字號:衛署醫器輸字第015098號

【“貝克”食道置放器】許可證字號:衛部醫器製字第006603號

【“索芙特摩”法西瑪海水鼻用噴霧器 (未滅菌)】許可證字號:衛署醫器輸壹字第007896號

【“渥克”艾翠光凝流動複合樹脂】許可證字號:衛部醫器輸字第028051號

【“伯瑞” 抗生素感受性試驗紙錠-莫匹羅星】許可證字號:衛部醫器輸字第027676號

【“榮研”自動尿液分析儀】許可證字號:衛署醫器輸壹字第005906號

【"成春" 一般手術用手動式器械 (未滅菌)】許可證字號:衛部醫器陸輸壹字第002751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