June 2024

Regulatory Affairs Update: Indonesia

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

The procurement process through the e-Catalogue website of the the Procurement Goods/Services (LKPP: Lembaga Kebijakan Pengadaan Barang dan Jasa Pemerintah) under the Ministry of Health (MoH) of Indonesia has been updated. The MoH has extended the listing deadline until 31 December 2024. In addition, the Freezing and Unfreezing process in the e-Catalogue, regulated under the MoH […]

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Regulatory Affairs Update: Thailand

Thailand: Criteria, Methods, And Conditions To Install Medical Devices Outside The Premises Specified In The Certificate

On April 25, 2024, the Ministry of Public Health (MOPH) announced the Criteria, Methods, and Conditions for Assembly to Install Medical Devices Outside the Place Specified in the Certificate of Establishment, License, Notification license, or Listing License, B.E. 2567 (2024). The registrant, licensee, notifier, or the listing licensee who assembles and installs medical devices outside

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Regulatory Affairs Update: Thailand

Thailand: Simplification Of The Registration Process For Medical Devices

The Thai Food and Drug Administration (TFDA) implemented a new notification aimed to simplify the registration process of medical devices under the “Specification of Data, Documents, or Evidence Not Required for Submission under the Ministerial Regulations on the Permission and Issuance of Licenses for the Manufacturing or Importation of Medical Devices and the Notification License

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Regulatory Affairs Update: Thailand

Thailand: List of Foreign Agencies Accepted by the TFDA for Inspection or Certification of Medical Devices or Medical Device Establishments

On June 4, 2024, the Thailand Food and Drug Administration (TFDA) announced the list of foreign agencies recognized or accepted for inspection or certification of medical devices or its establishments. The details are as elaborated below: No. Agency Condition 1 Therapeutic Goods Administration (TGA) It is a medical device that has been approved to be

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Regulatory Affairs Update: Malaysia

Malaysia: MDA Announced The Implementation Of Electronic Establishment License Certificates Starting June 5, 2024

The Medical Device Authority (MDA) has announced the implementation of electronic establishment licenses, effective from June 5, 2024. Once the application is completed (status complete) and the license fee has been paid, establishments may download the establishment license from the MeDC@St2.0+ system. Additionally, MDA will continue to issue physical establishment license certificates for use by

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Regulatory Affairs Update: Malaysia

Malaysia: Revocation Of Medical Device Authority (MDA) Circular No. 1/2022: Exemption Of The Compliance Assessment Process By Conformity Assessment Bodies (CAB) For The Registration Of COVID-19 Test Kits

The Medical Device Authority (MDA) has announced the revocation of Circular Letter No. 1/2022, which exempted the compliance assessment process by Conformity Assessment Bodies (CAB) for the registration of COVID-19 test kits under the Medical Device Act 2012. Effective February 23, 2024, COVID-19 test kit registration must adhere to the procedures outlined in the MDA/GL/IVD-1

Malaysia: Revocation Of Medical Device Authority (MDA) Circular No. 1/2022: Exemption Of The Compliance Assessment Process By Conformity Assessment Bodies (CAB) For The Registration Of COVID-19 Test Kits Read More »

Regulatory Affairs Update: Malaysia

Malaysia: MDA Announced the Implementation of the One License Per Establishment Role Policy Starting July 1, 2024

Following the enactment of the One License Per Establishment Role Policy outlined in the “General Directive of the Minister of Health No. 1/2024, in accordance with the provisions of the Medical Device Authority Act 2012 [Act 738]: Implementation of the One License Per Establishment Role Policy,” the Medical Device Authority (MDA) of Malaysia has declared

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Regulatory Affairs Update: Malaysia

Malaysia: Draft on Guidance Documents: Change Notification For Registered Medical Device – Fifth Edition

On May 23, 2024, the Medical Device Authority (MDA) of Malaysia issued a draft guidance document for the fifth edition of Change Notification for Registered Medical Devices, designated as MDA/GD/0020. The main highlights from this draft guidance document are as follows:  Establishments are required to identify the appropriate application type, either Single Application or Multiple

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Regulatory Affairs Update: Indonesia

Indonesia: Ministry of Health Letter of Filling New System of Pharmacy and Medical Device Dictionary (KFA: Kamus Farmasi dan Alat Kesehatan)

On May 21, 2024, the Indonesian Ministry of Health (MoH) issued a letter numbered FR.03.01/E.V/1179/2024 regarding Filling the New System of Pharmacy and Medical Device Dictionary (KFA), which was signed on 14 May 2024. KFA is a dictionary that contains unique codes for pharmaceutical products and medical devices and can be used and integrated into

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Regulatory Affairs Update: Thailand

Thailand: FDA Announced a Comprehensive Guide to Evaluating Academic Documents and Medical Device Licensing Inspections

Thai Food and Drug Administration (FDA) announced the Criteria, Methods, and Conditions for Evaluating Academic Documents, Analysis, Establishments Inspection or Inspections for Consideration and Permission of Medical Device Licensing, B.E. 2567 (2024). The goal is to streamline the licensing process for medical devices while maintaining high quality, efficiency, and safety standards. Highlights of the announcement

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Regulatory Affairs Update: Thailand

Thailand: Draft Announcement on The Highest Rates of Expenses for Document Evaluation, Analysis, Business Establishment Inspection, or Medical Device Inspection for Monitoring, Auditing, or Surveillance to Control the Manufacturing, Import, and Sale of Medical Devices

The Thailand Food and Drug Administration (TFDA) issued a draft announcement governing the highest rates of expenses for document evaluation, analysis, business establishment inspection or medical device inspection monitoring, auditing, or surveillance to control the manufacturing, import, and sale of medical devices. This announcement will be effective after its issuance date in the Royal Gazette.

Thailand: Draft Announcement on The Highest Rates of Expenses for Document Evaluation, Analysis, Business Establishment Inspection, or Medical Device Inspection for Monitoring, Auditing, or Surveillance to Control the Manufacturing, Import, and Sale of Medical Devices Read More »

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