The Medical Device Authority of Malaysia (MDA) announced that enhancements have been made to the MeDC@St 2.0+. For notification module, an improved features have been added to the Clinical Research Use sub-module as follows: The online form has a new look and allows batch uploads on medical device listings. Print
The Medical Device Authority (MDA) released the Third Edition Guidance Document of Medical Face Mask and Respirator (MDA/GD/0033) on May 19, 2023. This guideline was intended to provide clarification on medical face masks and respirators regulated under the Section 2 of Medical Device Act (Act 737) and is applicable to
The Health Sciences Authority of Singapore (HSA) is soliciting the industry’s feedback on the Draft Guidance Document: GN-14 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices Revision 3. Updates in the Draft Guidance Document includes: Inclusion of Standalone software (SaMD) definition per IMDRF; Clarifications on the classification
Starting May 2, 2023, the Medical Device Authority of Malaysia (MDA) will implement the use of ‘Electronic Medical Device Registration Certificate’. This electronic medical device registration certificate can be downloaded from the MeDC@St2.0+ system once the application status is deemed as complete. A transition period up until December 31, 2023,
The Philippines Food and Drug Administration (FDA) issued an advisory to inform that they will not be accepting any online applications for any services, except for applications for Compassionate Special Permit (CSP) and Certificate for Customs Release (CFCR), during their system maintenance and upgrade period. Starting 05 April 2023, all
In consideration of the challenges brought about by the full implementation of AO 2018-002, the FDA recognizes that there is a need to provide medical device companies more time to prepare the technical documentary requirements based on the ASEAN Common submission dossier template (CSDT) in applying for CMDR. With this,
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