Philippines FDA Publishes Circular on Abridged and Verification Review Pathways
The Philippines Food and Drug Administration (FDA) has issued FDA Circular No. 2022-004, which provides insight on the facilitated registration …
Hong Kong Drug Office Releases Guidance Notes on Classification of Products
Hong Kong Drug Office has published some guidance notes on the classification of products as “pharmaceutical products” in June 2022. …
Thailand FDA and Singapore HSA Collaborate on Expedited Medical Device Registration Program
The Food and Drug Administration (FDA) of Thailand and Health Sciences Authority (HSA) Singapore have formed an expedited program to …
MDA Malaysia Releases Latest Guidance on Classification for General Medical Devices
The Malaysian Medical Device Authority (MDA) has released the second edition of the guidance document on the rules of classification …
Australia TGA Issues Factsheet on Software-Based Medical Devices in Digital Mental Health
The Therapeutic Goods Administration (TGA) Australia has released a factsheet on software based medical devices in digital mental health in …
Hong Kong Drug Office Updates Frequently Asked Questions’ Page
Hong Kong Drug Office has provided the latest set of frequently asked questions (FAQs) on their official website at the …
Singapore HSA Publishes Updated Guidelines on Software Medical Devices
The Health Sciences Authority (HSA) Singapore has published an updated version of the guidelines for software medical devices (MD) in …
Philippines FDA Updates Circular on Transition Period for Certificate of Medical Device Notification
The Philippines Food and Drug Administration (FDA) has issued FDA Circular No. 2021-002-B, an amended version of Circular No. 2021-002-A. …
Singapore HSA Publishes Guidelines on Risk Classification of Standalone Medical Mobile Applications and Qualification of Clinical Decision Support Software
The Health Sciences Authority (HSA) Singapore has published the first version of the guidelines on the determination of risk classification …