The Philippines Food and Drug Administration (FDA) has issued FDA Circular No. 2022-005, which provides some information on the process on labelling drug products under Maximum Retail Price (MRP), in
read more...Regulatory News
Hong Kong Drug Office Publishes Frequently Asked Questions for Clinical Trial Certificates
Hong Kong Drug Office has published a set of frequently asked questions on the application for clinical trial certificate (CTC) in June 2022.
The document covers some pertinent topics, including the
MDA Malaysia Publishes Guideline on Re-registration of Registered Medical Device
The Malaysian Medical Device Authority (MDA) has released the first edition of the guideline on the re-registration process for registered medical devices in June 2022.
There are two stages for the
read more...Australia TGA Publishes Latest Clinical Evidence Guidelines for Medical Devices
The Therapeutic Goods Administration (TGA) Australia has released the latest guidelines on clinical evidence requirements for medical devices, including in vitro diagnostic medical devices (IVDs), in June 2022.
One of the
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 pathways (FRPs) available for new drugs (including vaccines and biologicals),
read more...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.
A product will need to be assessed to determine its eligibility
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 support the registration of medical devices in Thailand. The latest
read more...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 for general medical devices in May 2022.
There are updates to
read more...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 May 2022.
Some examples of these medical devices include any app