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
Regulatory News
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),
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
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
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
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 end of April 2022.
The page for FAQs covers a range
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 April 2022.
One of the updates is under the pre-market product