andamanmedical

The Philippines FDA issued Circular no. 2021-002 on Monday 4th January 2021, which contains the implementation scheduleof the Administrative Order No 2018-002: “Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements” over three (3) phases. Administrative Order (AO) no. 2018-002 section IX stipulates that the requirement of registration for all medical

The Philippines Food and Drug Administration (FDA) has resumed access to its online Verification Portal which provides comprehensive lists of FDA Licensed Establishments and Registered Health Products. The portal is open access so that the general public can verify whether a medical device placed in the Filipino market is properly licensed and distributed by an authorized dealer. The portal was

Updated guidelines on the evaluation of COVID-19 test kits have been released by the Research Institute for Tropical Medicine (RITM) in the Philippines, which cover the “…Evaluation of In Vitro Diagnostic Medical Devices and other related laboratory diagnostic supplies for COVID-19”. These guidelines cover the evaluation of PCR test kits, in vitro reagents, and other

The National Telecommunications Commission of the Philippines issues permits and certificates to importers of indoor equipment and devices that require Wireless Data Networks (WDN) or are WIFI-enabled or Bluetooth-enabled medical devices.  Background The National Telecommunications Commission (NTC) is responsible for the supervision, adjudication, and control of all telecommunication services in the Philippines. The NTC works closely

To ensure safety, the Philippines FDA will ban powdered medical gloves and have advised the general public, including all healthcare professionals, that powdered gloves will be phased out by the end of 2018 in favor of powder-free medical gloves. The Philippines Food and Drug Administration (FDA) has released Advisory No. 2017-180, dated June 20, 2017,

All local manufacturers, distributors (importers, exporters and wholesalers), traders and re-packers of medical devices, in-vitro medical devices and health-related devices in the Philippines shall comply with the labeling requirements as drafted by the Center for Device Regulation, Radiation Health and Research (CDRRHR). Republic Act No. 3720 (Food, Drugs and Devices and Cosmetics Act), as amended by RA