The Philippines Food and Drug Administration (FDA) is seeking comments from IVD manufacturers and distributors (importers/exporters/wholesalers) on draft guidelines entitled “Specific list of registrable IVD medical devices and revised technical requirements for registration of COVID-19 test kits”. The draft FDA Circular provides a specific list of registrable IVDs including the
Indonesia’s Ministry of Health has announced that it has simplified registration for some Class A medical devices and Classes 1 & 2 of household health supplies (PKRT). Medical Device Distribution Certificate (IDAK, previously called SDAK) holders can take advantage of this new simplified registration by applying for a Distribution Permit
The Malaysian Medical Device Authority (MDA) has launched an enhanced version of MeDC@St, its online application system for medical device registrations, at the end of January 2022. MeDC@St 2.0+ will incorporate additional features such as changes to certain modules including: Change Notification module Change notification applications are now allowed to
The Philippines Department of Health (DOH) has released guidelines on the appropriate procurement, distribution and use of antigen self-test kit on 26 January 2022. The guidelines include instructions to manufacturers, suppliers and distributors on ensuring that the instructions for use are user-friendly including a requirement to create a step-by-step video
The Singapore Health Sciences Authority (HSA) has updated regulatory Guidance GN-15 on Medical Device Product Registration to expand the types of approvals from the following reference regulatory agencies: For Class B Medical Devices, the updated reference agencies’ approval types include: The US Food and Drug Administration (US FDA) De Novo
The Singapore Health Sciences Authority (HSA) has issued updated Guidance on the Grouping of Medical Devices for Registration (GN12-2 revision 2). This concerns: Dental Medical Devices of Class B only which wish to apply for registration using dental grouping terms. Applicants may group their dental devices using GN-12-1 or
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