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Market Information
Philippines healthcare expenditure was forecast to continuously increase between 2024 and 2028 by in total 9.6 billion U.S. dollars.
Market Trend: The Philippines healthcare insurance market is projected to grow from $4.46 Bn in 2022 to $8.31 Bn by 2030, registering a CAGR of 8.1% during the forecast period of 2022-2030.
Philippines medical equipment market's revenue is expected to show an annual growth rate (CAGR 2023-2028) of 10.78%, resulting in a market volume of US$1,218.00m by 2028.
The Center for Device Regulation, Radiation Health, and Research (CDRRHR) operates as the national body within the Department of Health's Food and Drug Administration, overseeing the control of manufacturing, importation, exportation, distribution, sales, advertising, and utilization of electrical or electronic devices with radiation-emitting capabilities.
Medical Device Regulation
Center for Device Regulation, Radiation Health, and Research (CDRRHR), under the FDA.
https://www.fda.gov/about-fda/fda-organization/center-devices-and-radiological-health
Classification, Fees, Timeline
DEVICE CLASS | FEES | TIMELINE |
|---|---|---|
Class A: CMDN | PHP 1,515 ++ | 1 to 2 months |
Classes B, C & D: CMDR | PHP 7,575 | 6 to 9 months |
IVD: CPR | PHP 7,575 | 6 to 9 months ++ |
Product Registration Routes
Medical devices must be approved in country of origin before they can register in the Philippines.
DEVICE CLASS | CONDITION |
|---|---|
Class A: CMDN | Notification |
Classes B, C & D: CMDR | Registration |
IVD: CPR | Registration |
PATHWAY | CONDITIONS |
|---|---|
Abridged | |
Full |
-
Only has approval from country of origin
-
Only has approval reference agencies and ASEAN
Reference agencies: AU, CHINA, CND, EU, JP, KR, SWISS, UK, US
Useful Information
Validity of License: 5 years.
License transfer: Transfer application requires the original registration certificate.
Importer and Distributor: Local License Holder, on behalf of the product owner, is responsible to appoint Importers and Distributors.
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