Malaysia’s Medical Device Authority (MDA) issued a reminder on 5 April 2022 that imported medical devices must be registered and imported by a licensed establishment as provided in sections 5 (1) and 15 (1), Medical Devices Act 2012 (Act 737) or obtain any approval issued by MDA. If you are
The Medical Device Authority (MDA) said that based on the definition under section 2 of Act 737, only disinfectants used to disinfect medical devices are categorized as medical devices. Other disinfectant products including body spray disinfectant are not categorized as medical devices and therefore they are not subject to the
The Medical Device Authority (MDA) decided on 29 March 2022 to replace the requirement of lot-to-lot variation tests. Instead, it’s instituting the approval of a new lot of COVID-19 test kits with the requirement under the post market duties and obligations of the establishment. With this arrangement, the establishment shall
The MDA Covid-19 assessment Committee Of experts has agreed that all Covid-19 test kit applications pending Conditional Approval and Special Access will be halted. In addition, all future applications will be submitted using the Medcast online system. The deadline for applications pending in CA and SA is set for March
The Health Sciences Authority Singapore has published updates to the guidance document titled ‘GN-21: Guidance on Change Notification for Registered Medical Devices Revision 4.9’. This guidance document takes effect on 25 April 2022. The main update in this revision is about ‘Change in Design and/or Specifications of General Medical Devices’
All Class B, C and D medical devices that are already in the Philippine market prior to the effectivity of FDA Circular 2021-002-A may continue to be manufactured, imported, exported, distributed, transferred, sold, or offered for sale without CMDN shall be extended until 31 March 2023. The Food and Drug
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