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PHILIPPINES: PFDA amends administrative order No. 2018-0002 “Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements” – July, 2019

PHILIPPINES: PFDA amends administrative order No. 2018-0002 “Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements” – July, 2019

  • 2020-05-06 09:31:48

PFDA starts to iron out flaws ahead of the upcoming implementation of AO 2018-0002. Things to keep an eye out for are the new guidelines for risk classification, separate scope for refurbished medical devices, guidelines and process of securing licenses for local medical products.

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[ANALYSIS] Dipping into the healthcare market of the Philippines - Facts, Opportunities and Imminent Changes - June, 2019

[ANALYSIS] Dipping into the healthcare market of the Philippines - Facts, Opportunities and Imminent Changes - June, 2019

  • 2020-05-06 07:05:38

The Medical Device Market of the Philippines offers Foreign Manufacturers a wealth of opportunities, due to the strong demand for innovative devices and the market’s extreme dependency on foreign imports. With local production covering less than 10% of the national demand and being restricted to a small variety of products, the Philippines promise favorable conditions for foreign companies interested in expanding to Asia.

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