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市场信息
USA’s healthcare expenditure witnessed a 4.1 percent growth in healthcare spending in 2022, amounting to $4.5 trillion, equivalent to $13,493 per person. This health spending represented 17.3 percent of the nation's Gross Domestic Product.
Market Trend: An estimated 304 million, or 92.1%, Americans had health insurance in 2022.
Singapore’s medical equipment market is expected to show an annual growth rate (CAGR 2024-2028) of 5.49%, resulting in a market volume of US$225.40bn by 2028.
The Food and Drug Administration (FDA), operating under the Department of Health and Human Services (HHS), oversees the safety and efficacy of medical devices. The Center for Devices and Radiological Health (CDRH), formed in 1982, plays a key role in the regulation of medical devices.
Medical Device Regulation
Center for Devices and Radiological Health (CDRH), under the FDA.
https://www.fda.gov/about-fda/fda-organization/center-devices-and-radiological-health
分类、费用、时间表
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产品注册途径
Class I
General Controls, exempted from 510(k) submission.
Class II
General Controls and Special Controls, requires 510(k) submission.
Class III
General Controls and Premarket Approval (PMA)
有用信息
Validity of License: Indefinite, unless revoked or product recalled. Annual Establishment Registration is required.
License transfer: Not necessary to notify FDA about the transfer of a 510(k) clearance (although the new 510(k) holder will be required to file device listing form FD-2892).
Importer and Distributor: Local License Holder, on behalf of the product owner, is responsible to appoint Importers and Distributors.
