December 2021

Medical device cyber security alert apache log4j

Medical Device cyber security vulnerability: Apache-Log4j

On 22 December 2021, the Health Sciences Authority (HSA) of Singapore published a medical device advisory alerting all industry stakeholders about a recent suite of cybersecurity vulnerabilities known as the Apache Log4j Vulnerabilities, that could potentially affect medical devices utilizing the Apache Java Logging Library Log4j. These cybersecurity vulnerabilities allow remote code execution by attackers […]

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Philippines FDA medical device authorizations during public health emergency

Philippines FDA medical device authorizations during state of emergency

The Philippines FDA issued Circular no. 2021-025 listing the latest guidelines for the application of FDA authorizations in light of the extended state of public health emergency. The extended state of emergency came into effect on 13 September 2021 by Proclamation no. 1218 and will last until 12 September 2022 unless lifted earlier or extended

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Vietnam product labeling new regulation

Vietnam issues new regulation for product labeling

On 9 December 2021, the Vietnam government released Decree No. 111/2021/ND-CP which amended Decree No. 43/2017/NĐ-CP on product labeling regulation, including medical devices.  This decree will come into effect on 15 February 2022. According to this new decree, organizations and individuals producing, exporting, and importing goods must determine and label the origin of goods, as

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Indonesia Medical Device Online Registrations Temporarily Closed

Indonesia Medical Device Online Registrations to Close Temporarily

The medical device online registration system in Indonesia, Kemkes, will be shut down temporarily, as of 20 December 2021 to 14 January 2022 for maintenance purposes. This was announced on 1 December 2021 by the Ministry of Health in letter No. UM.01.05/5/2046/2021. This means that the online registration system (http://regalkes.kemkes.go.id) will be closed for the

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Product classification medical device singapore

Medical Device Product Classification Guidance for Singapore

New guidance on classifying products as medical devices has been issued by the Health Sciences Authority (HSA), Singapore. The publication of the final document entitled “Medical Devices Product Classification Guide” at the end of November 2021 follows a stakeholder consultation earlier in the year and incorporates additional clarifications on product types as per the feedback

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Singapore Regulatory Fee Increase for Medical Devices

Regulatory Fee Increase for Medical Devices in Singapore

A regulatory fee increase for medical devices in Singapore has been announced by the Health Sciences Authority (HSA). The fee increases apply to various health product categories, retail pharmacies licensing, and permit issuances. The announcement was made on 1 December 2021; the average increment of 3% will take effect on 1 July 2022. The affected

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meet patcharawat andaman medical thailand

Medical device importation to Thailand

Over the summer, Andaman Medical was happy to welcome a new member of staff in Thailand, Mr. Patcharawat Lertcharoenbundit as Logistics Specialist. The arrival of Patcharawat means we have further strengthened our importation service offering in Thailand. Patcharawat has 4 years’ experience as a Regulatory Affairs Pharmacist; he graduated from the Faculty of Pharmaceutical Sciences

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Vietnam issues new regulation for medical device management

Vietnam issues new regulation for medical device management

On 8 November 2021, the Vietnam government signed Decree 98/2021/ND-CP regulating the management of Medical Devices. The new decree enters into force on 01 January 2022. From this date, Decree 36/2016/NĐ-CP, Decree 169/2018/NĐ-CP, and Decree 03/2020/NĐ-CP will become obsolete. The new decree covers many aspects of medical device management from registrations to advertising, from import

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