May 2024

Regulatory Affairs Update Thailand

Thailand: Draft Announcement on the Expenses for Document Evaluation, Analysis, 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 expenses for document evaluation, analysis, establishment inspection, or medical device inspection for monitoring, auditing, or surveillance to control medical device manufacturing, import, and sale. This announcement will be effective 90 days after issuance in the Royal Gazette. The expenses for document evaluation, […]

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

Andaman Medical Regulatory Affairs Update Malaysia

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On May 23, 2024, the Medical Device Authority (MDA) of Malaysia issued a draft guidance document for the fifth edition of Change Notification for Registered Medical Devices, designated as MDA/GD/0020. The main highlights from this draft guidance document are as follows:• Establishments are required to identify the appropriate application type, either Single Application or Multiple

Malaysia: Draft For Public Comment on Guidance Documents: Change Notification For Registered Medical Device – Fifth Edition Read More »

Regulatory Affairs Update: Vietnam

Vietnam: Issuance of New Circular Governing the List of Products Eligible for Price Negotiation and Its Processes by Vietnam’s Ministry of Health

On May 14, 2024, the Ministry of Health of Vietnam issued Circular 05/2024/TT-BYT regulating the list of drugs, medical devices, and testing supplies eligible for price negotiation and the process and procedures for selecting contractors for bidding packages and applying for price negotiation. This circular takes effect from May 15, 2024. Accordingly, the list of

Vietnam: Issuance of New Circular Governing the List of Products Eligible for Price Negotiation and Its Processes by Vietnam’s Ministry of Health Read More »

Regulatory Affairs Update: Malaysia

Malaysia: Encouragement to Submit Medical Device Re-Registration Applications One Year before the Certificate Expiration Date

Per the MDA/GL/08 entitled “Guidelines for Re-Registration of Registered Medical Devices,” applications for medical device re-registration are to be submitted online via the MeDC@St 2.0+ system one year before the certificate expiration date. The re-registration button will become available in the system one year prior, allowing establishments to submit their applications. Simultaneously, as a form

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Regulatory Affairs Update: Singapore

Singapore: HSA’s Registration Approvals Recognised by Hong Kong MDD for Class II / III / IV Listing in Hong Kong

Medical device companies can use the registration approvals accorded by the Health Sciences Authority (HSA) of Singapore to enter the Hong Kong market starting 02 April 2024. The HSA issued this information via the April 2024 Nexus Newsletter. This means that valid registration approvals could be used to demonstrate conformance to the Essential Principles of

Singapore: HSA’s Registration Approvals Recognised by Hong Kong MDD for Class II / III / IV Listing in Hong Kong Read More »

Regulatory Affairs Update: Indonesia

Indonesia: Guidelines for the Circulation of Medical Devices and Household Health Supplies (PKRT: Perbekalan Kesehatan Rumah Tangga) through Electronic Systems

Indonesia Ministry of Health (MoH) shared Guidelines for the Circulation of Medical Devices and Household Health Supplies through Electronic Systems which was signed on 05 April 2024. The guideline is intended as a reference for business actors, medical device and Household Health Supplies associations, and other stakeholders in implementing the circulation of medical devices and

Indonesia: Guidelines for the Circulation of Medical Devices and Household Health Supplies (PKRT: Perbekalan Kesehatan Rumah Tangga) through Electronic Systems Read More »

Regulatory Affairs Update: Indonesia

Indonesia: Implementation of GDPMD Certificate (CDAKB: Cara Distribusi Alat Kesehatan yang Baik) as a Requirement for Marketing Authorization

On May 07, 2024, the Indonesia Ministry of Health issued an Announcement Number FR.03.06/E.V/1095/2024 about the Implementation of the GDPMD Certificate (CDAKB: Cara Distribusi Alat Kesehatan yang Baik) as a Requirement for Marketing Authorization that was signed on 30th April 2024. Based on the Regulation of the Minister of Health Number 4 of 2014 concerning

Indonesia: Implementation of GDPMD Certificate (CDAKB: Cara Distribusi Alat Kesehatan yang Baik) as a Requirement for Marketing Authorization Read More »

Regulatory Affairs Update: Malaysia

Malaysia: Medical Device Authority (MDA) Released Circular Letter No. 1/2024: Medical Devices Imported from or Exported to Countries with No Diplomatic Relations with Malaysia Subject to Trade Restrictions

The Medical Device Authority of Malaysia (MDA) has issued Circular Letter No. 1 of 2024 titled “Medical Devices Imported from or Exported to Countries with No Diplomatic Relations with Malaysia Subject to Trade Restrictions.” In accordance with the implementation of Circular Letter No. 1/2024, the procedure for registering medical devices imported from or exported to

Malaysia: Medical Device Authority (MDA) Released Circular Letter No. 1/2024: Medical Devices Imported from or Exported to Countries with No Diplomatic Relations with Malaysia Subject to Trade Restrictions Read More »

Regulatory affairs update: Thailand

Thailand: Thai FDA Announces Streamlined Procedures: Exemption of Hard Copy Documents for Regulatory Transactions

Thai FDA has announced exemptions for certain hard copy document submissions to streamline processes and administrative load on registrants. In this announcement, registrants contacting divisions under the Thai FDA authority will no longer be required to furnish hard copies of their ID card, household registration, and company affidavit. This significant update aims to enhance efficiency

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