The FDA Circular No. 2021-021, which took effect on 18 December 2021, was issued to provide guidelines on the licensing of retailers of medical devices in the Philippines, as well as acting as a supplement for the previously issued Administrative Order (AO) No. 2020-0017 regarding the simplification of the requirements
On March 25th, 2024, the Medical Device Authority (MDA) of Malaysia published an announcement regarding faster approval for establishment license applications. The complete applications will be processed within 14–21 working days after the review officer receives them. The following elements will be reviewed during the evaluation process: An updated Letter
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
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