醫療器材Q＆A (3) | 合法醫療器材資訊網

Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III ... Read More

Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III ... Read More

and Drug Administration, FDA)，將其歸類為Class Ⅲ。依據法規， Class Ⅲ的器材原則. 上在美國皆須經由上市前核可(Premarket Approval, PMA)申請，方可於 ... Read More

2021年6月9日 — An approved Premarket Approval Application (PMA) -- like an approved New Drug Application (NDA) -- is, in effect, a private license granted to ... Read More

2019年5月16日 — A Premarket Approval (PMA) application is a scientific, regulatory documentation to FDA to demonstrate the safety and effectiveness of the Class ... Read More

2020年5月22日 — Overview; Steps in the PMA Process; Early Collaboration & Day-100 Meetings; FDA Action on a PMA; References ... Read More

2020年8月31日 — Alphabetical Listing of PMA Guidance Documents. 30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day ... Read More

任何人或製造商若要將醫療器材產品（Class I,II,III）行銷到美國，除部分免510(k)​品項及無須進行上市前核准（Premarket Approval, PMA）外，都必須在進口美國 ... Read More

2. 上市前審查（Premarket Approval，PMA）：此上市途徑主要為. Class Ⅲ醫療器材，部分為經FDA 判定不符合實質相等性. （Substantial Equivalence，SE）​模式 ... Read More