• 2022-09-27 07:47:09

PFDA held a public hearing about updated draft for the In-vitro diagnostic (IVD) medical device regulation and registration in the Philippines including discussion on transition period and implementation timeline.

• 2022-02-18 08:32:17

PFDA released draft document of the updated guidelines for in-vitro diagnostic medical devices (IVD) certification. This new regulation will conform to the risk-based classification of the ASEAN medical device directive (AMDD). A tentative list of registrable IVDs together with a revised set of requirements to register COVID-19 Test Kits was also released on a separate document.

• 2021-08-01 15:11:37

Recently, NMPA issued has issued a draft Regulation on self-testing for medical device registration. It has been published for public comments.

• 2020-12-23 01:53:56

To further develop a more practical and effective safety surveillance system, TFDA has set up regulations of serious adverse event reporting especially for medical devices. This article leads you into the main differences of the current and upcoming regulations.