On March 25th, 2024, the Medical Device Authority (MDA) of Malaysia posted an announcement regarding Establishment License Information. Per Section 15 (1) of the Medical Device Act (Act 737), it was stated that no establishment shall import, export, or place in the market any registered medical device unless it holds
The Philippines’ Food and Drug Administration (FDA) previously issued FDA Circular No. 2021-021, supplementing the Administrative Order (AO) of the Department of Health No. 2020-0017, which took effect on 18 December 2021. Section IX of the said Circular stated that all retailers should be given 2 years from the circular’s
On April 01, 2024, the Bureau of Procurement of Goods and Services (BPBJ: Biro Pengadaan Barang dan Jasa) Ministry of Health socialized a Decree of the Minister of Health of the Republic of Indonesia No. HK.01.07/MENKES/163/2024 which was assigned on 26 February 2024 about Consolidated Display on Sectoral Electronic Catalogue
During the harmonization to ASEAN requirements, the Philippines Food and Drug Administration (PFDA) aims to prevent a negative impact on the supply of medical devices by issuing past provisions FC No. 2021-002A, FC No. 2021-002B, and FC No. 2021-002C (valid until Mar 31, 2024) which provide regulatory flexibility to all
In the first quarter of 2024, The Department of Infrastructure and Medical Equipment released Decision No. 166/QĐ-BYT and Decision No. 490 / QĐ-BYT regarding the issuance of criteria and principles for assessment of the general technical documentation for Non-In Vitro and In-Vitro Medical Devices following ASEAN regulations (CSDT). They have
The Procurement Goods/Services (LKPP: Lembaga Kebijakan Pengadaan Barang dan Jasa Pemerintah) under the Indonesia Ministry of Health announces the updated timeline for the e-Catalogue listing has been extended until 30 June 2024. Stakeholders can still list their products in the e-Catalogue during the timeline announced until further notice. With regard
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