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
The FDA Circular No. 2021-021, which took effect on 18 December 2021, was issued to provide guidelines on the licensing of retailers of medical devices in the Philippines, as well as acting as a supplement for the previously issued Administrative Order (AO) No. 2020-0017 regarding the simplification of the requirements
On March 25th, 2024, the Medical Device Authority (MDA) of Malaysia published an announcement regarding faster approval for establishment license applications. The complete applications will be processed within 14–21 working days after the review officer receives them. The following elements will be reviewed during the evaluation process: An updated Letter
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