July 2021

Philippines second update license applications during covid-19

Philippines FDA issues second update to license application guidelines during Covid-19

The Philippines Food and Drug Administration (FDA) has issued a second amendment to its guidelines on FDA-issued authorizations due to the ongoing global pandemic and community quarantine requirements. FDA Circular 2020-024 entitled “Updated guidelines for applications of authorizations with the FDA in light of community quarantine declarations” was first issued on 20 August 2020. It …

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philippines essential medical device list

The Philippines announces introduction of essential medical device list and price ceilings

During the COVID-10 pandemic a list of essential medical devices was drawn up as they were deemed essential for public health in combatting Coronavirus. These products also had a mandatory price ceiling fixed. The Philippines government has since decided to extend this measure to medical devices in general in order to secure supply chains and …

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Philippines FDA consultation on ban on mercury containing thermometer

Philippines FDA consultation on ban of mercury-containing thermometers

The Philippines Food and Drug Administration (FDA) has extended the date for comments on a draft Circular on Banning all Mercury-Containing Thermometers, Sphygmomanometers, Dental Amalgam Capsules and Liquid Mercury for Use in Dental Restorative Purposes. Comments may be submitted until 14 August 2021. This draft circular follows guidelines issued in May 2020 by the Department …

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indonesia removes import duty covid-19 medical devices

Indonesia removes import duty for some Covid-19 related medical devices

On 12 July 2021, Indonesia’s Ministry of Finance has just released Regulation No.: 92/PMK.04/2021 which is the third amendment to Regulation No.: 34/PMK.04/2020 concerning the provision of customs facilities and/or excise and taxation on the import of goods for the purposes of handling the Coronavirus pandemic in Indonesia. Regulation No.: 92/PMK.04/2021 lists various products that …

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Indonesia simplifies registration for some Class A medical devices

Indonesia simplifies registration for some Class A medical devices

The Ministry of Health in Indonesia is simplifying the registration process for 34 Class A medical devices as well as some Class I and II Household Health supplies (Perbekalan Kesehatan Rumah Tangga or PKRT). The new process will require SDAK (Sertifikat Distribusi Alat Kesehatan) or Medical Device Distribution Certificate (MDDC) holders to obtain Distribution Permit …

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