Medical Devices | 合法醫療器材資訊網

FDAregulatesthesaleofmedicaldeviceproductsintheU.S.andmonitorsthesafety...Jun30-FDArecommendsusingonlyFDA-clearedorNIOSH-approved ...

End of the COVID-19 Public Health Emergency

The COVID-19 public health emergency (PHE) declared under section 319 of the Public Health Service (PHS) Act expired on May 11, 2023.

Existing emergency use authorizations (EUAs) for devices remain in effect, and the FDA may continue to issue new EUAs going forward while the EUA declarations under section 564 of the Federal Food, Drug, and Cosmetic Act are in effect and when the criteria for issuance of an EUA are met.

Stay Up To Date with COVID-19 and Medical Device News[1] References Stay Up To Date with COVID-19 and Medical Device News (www.fda.gov)

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

Medical Devices | 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

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【"坤日"保護性限制帶(未滅菌)】許可證字號:衛署醫器製壹字第003905號

【“波士頓科技”英賽特植入式心律去顫器】許可證字號:衛署醫器輸字第025201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

【“可立耳”聲音處理器】許可證字號:衛署醫器輸字第020541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

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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