Regulatory Updates

Regulatory Affairs Update Indonesia

Indonesia: Decree Of The Minister Of Health Of The Republic Of Indonesia Number HK.01.07/Menkes/163/2024 About Consolidated Display on Sectoral Electronic Catalogue

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

Regulatory Affairs Update: Philippines

Philippines: Extension of the Regulatory Flexibility for Class B, C, and D Medical Devices that are not Included in the List of Registrable Medical Devices Based on FDA Circular No. 2020-001-A

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

Regulatory Affairs Update: Indonesia

Indonesia: Listing Product Schedule Update in the Ministry of Health e-Catalogue

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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