醫療設備
醫療設備
美國食品和藥物管理局（FDA）監管並監督醫療設備和輻射發射產品的安全性。
FDA的設備與放射健康中心（CDRH）負責監管從事在美國銷售的醫療設備的製造，重新包裝，重新貼標籤和/或進口的公司。 CDRH還確保醫療設備的安全性和有效性，並防止不必要地暴露於輻射輻射產品。
FDA將醫療設備分為三類-I類，II類和III類。設備的類別確定了確保醫療設備的安全性和有效性所必需的監管控制級別，以及為了獲得FDA批准/批准而適用的營銷流程。 I類設備被認為是“低風險”的，II類設備需要“一般控制和特殊控制”，最後，III類設備需要獲得上市前批准（PMA）。
從醫療設備分類和企業註冊到必要的提交，Provision Consulting Group提供與您的醫療設備一起進入美國市場所需的所有服務。
PROVISION的FDA醫療器械諮詢服務包括：
For foreign manufacturers, finding distributors registered as initial importers with the FDA is not easy because most distributors in the US do not want to manage the complicated responsibilities of the initial importer. The ideal solution would be to identify an independent company that specializes in the initial importer role. Provision Consulting Group ("PCG"), with many years of experience assisting 650+ clients worldwide to navigate and comply with complex FDA medical device regulations, provides that exact professional initial importer service for our clients overseas.
Our FDA initial importer service allows foreign manufacturers to spend more time developing their devices rather than searching for distributors and learning FDA regulations. Our clients not only save the FDA's annual initial importer registration fee by designating PCG as their initial importer, but, more importantly, they reclaim valuable time that would otherwise be spent deciphering complex FDA regulations. Time is a precious resource that money can't buy!
Now, the services PCG provides:
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US Agent Service
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Recognized as a US Agent on behalf of foreign companies for the FDA and act as a mediator between foreign companies and the FDA (i.e. regarding inspection notices, warning letters or import alert letters)
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Assist in responding to questions from the FDA concerning the submissions and the products of foreign companies
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Deemed the emergency contact with the FDA
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Any foreign establishment engaged in the manufacturing, preparation, propagation, compounding, or processing of drugs imported into the United States must identify a “US agent” for that establishment
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Report death, serious injury, and malfunctions as well as register, report, and archive all non-conformities, customer complaints, recalls and post-market survey activities (803.40 and 803.42)
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Report of Corrections and Removals (806)
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Conduct Medical Device Tracking (821), if applicable
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Be in compliance with the FDA’s quality system requirements, including FDA’s on-site inspection (820)—the cost to cover the FDA inspection shall be billed separately at the time of the inspection
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Conform with specific procedures envisaged in regarding the storage, keeping and handling of the devices (820)
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Assist with customs clearance in regard to the US FDA initial importer identification
