Thailand Medical Device Regulations & Registration Process
The production of medical devices in Thailand was estimated around 4.9 million U.S. dollars in 2022. The total market size […]
MedTech Insights
Stay updated with the latest in medical technology through MedTech Insights. Explore trends, innovations, news, and expert analysis on healthcare devices, digital health, diagnostics, and MedTech advancements.
FAQs: Malaysia MDA Regulations for Medical Device Registration
Here are answers to some of the Frequently Asked Questions (FAQs) about Malaysia regulations for Medical Device registration. MDA Registration
Thailand Medical Device Import License Regulations
If you’re looking to import medical equipment into Thailand, you’ll need to get a Thai FDA license first. There’s paperwork, licenses,
Australia Medical Device Regulations & TGA Registration Guidelines
Australia’s medical device market is sizeable—about USD 6.34bn in 2023, with cardiology devices near USD 0.92bn—and is projected to hit
Thai FDA Updates Medical Device Advertising Rules – Jan, 2025
The Food and Drug Administration Announcement RE: Determination of Criteria, Conditions, and Requirements for Approval, Issuance of License, and License
In Vitro Companion Diagnostics Regulations In Australia
A Companion Diagnostic (CDx) is an in-vitro diagnostic (IVD) medical device that plays a critical role in personalized medicine treatment
In Vitro Diagnostics: Meaning, Types And Benefits
The term “in vitro” is a Latin word that means “in glass”. Thus, from a scientific approach, we can say
Q-Submission Meetings for Medical Devices with US FDA
Bringing a medical device to the US market involves more than just paperwork — the FDA often expects early discussions
UK Releases Amendment & Guidance on Regulations in 2024 for Medical Devices (Post-market Surveillance Requirements)
In January 2025, MHRA UK released guidance on implementation of amendments to Medical Devices Regulation 2024 regarding Post-market surveillance (PMS)