Regulatory updates Archives

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

May 29, 2024

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.

Andaman Medical Regulatory Affairs Update Malaysia

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

May 28, 2024

On May 23, 2024, the Medical Device Authority (MDA) of Malaysia issued a draft guidance document for the fifth edition of Change Notification for Registered Medical Devices, designated as MDA/GD/0020. The main highlights from this draft guidance document are as follows:• Establishments are required to identify the appropriate application type,

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

May 22, 2024

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,

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

May 21, 2024

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

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

May 14, 2024

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

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

May 13, 2024

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

Regulatory Updates

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

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

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

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

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

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

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