Regulatory updates Archives

Malaysia: Cancellation of the Regulation Governing the Exemption from the Compliance Assessment Process by the Compliance Assessment Body (CAB) for the Registration of COVID-19 Test Kits

April 23, 2024

On April 2nd, 2024, the Medical Device Authority (MDA) of Malaysia announced the cancellation of the Circular of the Authority for Medical Devices (PBPP) Number 1/2022: Exemption from the Compliance Assessment Process by the Compliance Assessment Body (CAB) for The Registration of Covid-19 Test Kits. This requirement applies to manufacturers

Andaman Medical Regulatory Affairs Update Philippines

Philippines: Extension Of The Transitory Provision On The Licensing Of Retailers Of Medical Devices

April 22, 2024

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

Malaysia: Announcement on Faster Approval for Establishment License Application

April 16, 2024

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

Malaysia: Establishment License Information By The Malaysian MDA

April 16, 2024

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

Philippines: Extension of Transition Period for Licensing of Retailers of Medical Devices

April 15, 2024

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

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

April 9, 2024

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 Updates

Malaysia: Cancellation of the Regulation Governing the Exemption from the Compliance Assessment Process by the Compliance Assessment Body (CAB) for the Registration of COVID-19 Test Kits

Philippines: Extension Of The Transitory Provision On The Licensing Of Retailers Of Medical Devices

Malaysia: Announcement on Faster Approval for Establishment License Application

Malaysia: Establishment License Information By The Malaysian MDA

Philippines: Extension of Transition Period for Licensing of Retailers of Medical Devices

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

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