The Health Sciences Authority (HSA) of Singapore has been recognized by the World Health Organization (WHO) as a WHO Stringent Regulatory Authority (SRA) for high-risk (Class C and D) in vitro diagnostic medical devices (IVDs). The HSA joins the five founding members (European Union, The United States, Canada, Australia, and
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The Health Sciences Authority of Singapore (HSA) is soliciting the industry’s feedback on the Draft Guidance Document: GN-14 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices Revision 3. Updates in the Draft Guidance Document includes: Inclusion of Standalone software (SaMD) definition per IMDRF; Clarifications on the classification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
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