On 23 December 2022, Malaysia’s Medical Device Authority (MDA) has released a draft guidance document for the requirements of application of certificate of free sale (CFS), manufacturing certificate (MC) and certificate of free sale for export only (CFS EO) medical devices. This draft guidance document will serve as a revised
On 14 December 2022, the Medical Device Authority of Malaysia (MDA) has published an announcement on how to keep up with the MDA for their latest regulatory information and activities, which also known as Medical Device Authority-Regulatory Information Subscription (MDA-RIS). This program of e-mail notification subscription is an initiative by
The Health Sciences Authority (HSA) of Singapore published the 4th Revision of GN-35: Guidance on Special Access Routes (SAR) in January 2023. The major highlighted change of this revised regulation is regarding the stipulated turnaround-time (TAT) of 28 working days for Special Access Route (SAR) application review for specific categories
On 16 December 2022, the Medical Device Authority (MDA) of Malaysia has published an announcement to emphasize that all Conditional Approval and Special Access for COVID-19 test kits have been halted. Any future placement of COVID-19 test kits on the Malaysian market shall be subjected to their registration under section
On 13 December 2022, the Medical Device Authority of Malaysia (MDA) has published an announcement to emphasize the requirement for applying renewal of establishment license. The establishments (local manufacturer, authorized representative, distributor, and importer in Malaysia) shall apply for renewal of its establishment license at least 90 days before the
On 21 November 2022, the Ministry of Health (MoH) of Indonesia announced that a new development and improvement plan will be applied to the online licensing system of medical devices and household supplies registration, issuance of online certificates, and issuance of medical devices distribution license (IDAK). Therefore, the following changes
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