On December 31, 2024, the Vietnam Ministry of Health issued Notice No. 638/TB-HTTB, announcing the list of enterprises declaring medical device prices at the Ministry of Health. The list has been compiled under the provisions of Decree No. 85/2024/ND-CP, dated July 10, 2024, which outlines detailed regulations in the Law
On January 1, 2025, the Government of Vietnam issued Decree No. 04/2025/ND-CP, amending and supplementing several articles of Decree No. 98/2021/ND-CP regarding the management of medical devices. The decree extends the validity of medical device import licenses as follows: Import licenses for medical devices issued from January 1, 2018, to
The Director General of Posts and Information Resources and Equipment Decree No. 109/2024, regarding the recognition of Foreign Test Centres for Telecommunication Device Certification, expired on December 31, 2024. As of January 1, 2025, Test Result Reports issued by these Foreign Test Centres are no longer valid for the Certification
The Medical Device Authority (MDA) of Malaysia hosted a Facebook Live event on January 14, 2025, titled “Chief Executive New Year Message: What’s Beyond 2025”. Delivered by the MDA Chief Executive, the session highlighted key regulatory and developmental plans for the coming years. Key Highlights from the Facebook Live Event
On January 1, 2025, the Republic of Indonesia will officially implement Electronic Catalogue Version 6 for the procurement of goods and services, in accordance with a directive from the President of the Republic of Indonesia. As part of this transition, Electronic Catalogue Version 5 will be deactivated on December 31,
The Health Sciences Authority (HSA) of Singapore has issued a new guidance document, “GN-37-R1 Change Management Program (CMP) for SaMD, including machine-learning enabled SaMD,” which became effective on 4th December 2024. Key Highlights of GN-37-R1 Introduction of the Change Management Program (CMP) The CMP provides a framework for “pre-specified changes”
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