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
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
The CYBER SECURITY AGENCY (CSA) of SINGAPORE encourages Medical Device (MD) Manufacturers to join the Cybersecurity Labelling Scheme for Medical Devices [CLS(MD)] Sandbox, which started 20 October 2023 and will end in July 2024 The CLS(MD) label indicates the level of cybersecurity provisions and features in the devices and allows
On April 15th, 2024, Malaysia’s Medical Device Authority (MDA) announced the General Directive of the Minister of Health No. 1/2024 Pursuant to the Provisions of the Medical Device Authority Act 2012 [Act 738], regarding the Implementation of the Policy of One License for Each Establishment Role. This requirement applies to
On April 2nd, 2024, the Medical Device Authority (MDA) of Malaysia announced the cancellation of the Circular of the Authority for Medical Devices (PBPP) Number 1/2022: Exemption from the Compliance Assessment Process by the Compliance Assessment Body (CAB) for The Registration of Covid-19 Test Kits. This requirement applies to manufacturers
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