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
The Malaysian Medical Device Authority (MDA) released a new Guideline for the Registration of COVID-19 IVD Test Kits (MD/GL/07) on 24 January 2022. The guideline covers both the registration of COVID-19 test kits for those kits which have previously obtained Special Access Notification or Conditional Approval. It also covers registration
The Malaysian Medical Devices Authority (MDA) has decided that all COVID-19 test kits whether for professional use or for personal use must be registered under Section 5 of the Medical Devices Act 2012 (Act 737) before being placed on the market. This is effective as of 1 February 2022. This
The Food and Drug Administration Policy and Planning Service (FDA PPS) of the Philippines has issued draft guidelines for comments and input from industry stakeholders covering the categorization of borderline health products under the jurisdiction of the FDA. The FDA’s jurisdiction covers multiple product categories such as devices, cosmetics, drugs,
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