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
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
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
Abridged processing for applications of registration or notification of medical devices in the Philippines was introduced on 25 November 2021 as the Food and Drug Administration (FDA) issued Advisory No. 2021-3084. The introduction of this advisory means that medical devices that have already been approved by the regulatory authority of
New requirements for supplying COVID-19 Rapid Self-Test Kits in Malaysia were released by the Malaysian Medical Device Authority (MDA) on 10 November 2021 in Guidance Document MDA/GD/0059. The document guides companies on the requirements to follow in order to place Covid-19 Self-Test Kits on the market. This guidance is separate
Over recent years, the Vietnamese Government has issued various Decrees regulating the management of medical devices including: Decree No. 36/2016/ND-CP dated 15 May 2016; Decree No. 169/ND-CP dated 31 December 2018, and Decree No. 03/2020/ND-CP dated 01 January 2020. However, in order to unify regulations on medical device and equipment
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