The CYBER SECURITY AGENCY (CSA) of SINGAPORE encourages Medical Device (MD) Manufacturers to join the Cybersecurity Labelling Scheme for Medical Devices [CLS(MD)] Sandbox, which started 20 October 2023 and will end in July 2024 The CLS(MD) label indicates the level of cybersecurity provisions and features in the devices and allows users to make informed purchasing […]
On April 15th, 2024, Malaysia’s Medical Device Authority (MDA) announced the General Directive of the Minister of Health No. 1/2024 Pursuant to the Provisions of the Medical Device Authority Act 2012 [Act 738], regarding the Implementation of the Policy of One License for Each Establishment Role. This requirement applies to establishments that act as authorized
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 who want to register their
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 and processes for initial, renewal,
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 of Authorization (LOA) with accurate
Malaysia: Announcement on Faster Approval for Establishment License Application Read More »
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 an establishment license granted under
Malaysia: Establishment License Information By The Malaysian MDA Read More »
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 effectivity to comply with its
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 Ministry of Health. The legal
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 Class B, C, and D
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 provided the principles for evaluating
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 to Freeze and Unfreeze regulated
Indonesia: Listing Product Schedule Update in the Ministry of Health e-Catalogue Read More »
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ANDAMAN MEDICAL PTE LTD (Head Office Singapore)
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Level 09-02, 300 Tampines Avenue 5,
Singapore 529653
