From QSR to QMSR: FDA’s Quality Revolution For Medical Devices
The medical device’s domain marked one of its biggest evolutions by release of transition from Quality System Regulation (QSR) to […]
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.
IVD Medical Devices Registration & Approval In India
IVDs in India are regulated as drugs under Section 3(b)(i) and 3(b)(iv) of the Drugs and Cosmetics Act, 1940. With
Medical Devices Registration with MDA in Malaysia
The Medical Devices market in Malaysia is poised for significant growth, with projected revenue expected to reach MYR US$3,342.00m in
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
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