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,
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
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 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
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
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
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