Regulatory updates Archives

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

April 3, 2024

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

Vietnam: Decision on the Criteria and Principles for the ASEAN CSDT Assessment of Non-In Vitro and In-Vitro Medical Devices

April 3, 2024

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

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

April 2, 2024

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

Andaman Medical Regulatory Affairs Update

Philippines: Deletion Of COVID-19 Medicines And Devices From The List Of VAT-Exempted Health Products

March 26, 2024

The Philippines Food and Drug Administration (FDA) issued an Advisory No. 2024-0498 dated 06 March 2024, entitled “Delisting of COVID-19 Medicines and Devices from the List of VAT-Exempt Health Products”, informing the stakeholders and all concerned clients that the products used for COVID-19 shall no longer be VAT-Exempted, effective 01

Andaman Medical Regulatory Affairs Update Singapore

Singapore: HSA Regulations Alignment Related With Software / Programmed or Programmable Medical Device

March 26, 2024

The Health Sciences Authority (HSA) of Singapore made several key updates to align with current International Medical Device Regulators Forum (IMDRF) regulatory recommendations regarding software/programmed or programmable medical devices. Product owners that are involved in Software as a Medical Device (SaMD) either being standalone or embedded within the Medical Device

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

March 20, 2024

As of December 2023, the Policy Institute for Procurement Goods/Services (Lembaga Kebijakan Pengadaan Barang dan Jasa Pemerintah (LKPP)) under Ministry of Health (MOH) Indonesia has announced the schedule of Product Listing in e-Catalogue system for Health Facility in Indonesia is open until 31 March 2024 or until further notice. For

Regulatory Updates

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

Vietnam: Decision on the Criteria and Principles for the ASEAN CSDT Assessment of Non-In Vitro and In-Vitro Medical Devices

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

Philippines: Deletion Of COVID-19 Medicines And Devices From The List Of VAT-Exempted Health Products

Singapore: HSA Regulations Alignment Related With Software / Programmed or Programmable Medical Device

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

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