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Market Information

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.

Market Info

Medical Device Regulation

Center for Devices and Radiological Health (CDRH), under the FDA.

Classification, Fees, Timeline
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Product Registration Routes

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)

Useful Information

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.

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