Catch up on the important regulatory changes that are coming your way in 2021 for medical devices in Southeast Asia in the recording of our live presentation at the Medical Fair Asia, in December 2020. Shouzheng Tan presented a quick fire 20-minute overview of the “Key regulatory changes for 2021
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,
On 20 May 2020, the Medical Device Authority (MDA) in Malaysia, released its first circular letter of the year, stating that there will be a transitional period for the enactment of the Medical Device (Advertising) Regulation 2019. This regulation was due to come into full effect on 1st July 2020.
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
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.
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
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