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 establishments, healthcare facilities, and public […]
The Health Sciences Authority of Singapore (HSA) is soliciting the industry’s feedback on the Draft Guidance Document: GN-14 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices Revision 3. Updates in the Draft Guidance Document includes: Inclusion of Standalone software (SaMD) definition per IMDRF; Clarifications on the classification of control materials and software;
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, is given to the establishment,
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ANDAMAN MEDICAL PTE LTD (Head Office Singapore)
Tampines Junction Business Center
Level 09-02, 300 Tampines Avenue 5,
Singapore 529653
