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 […]
MedTech
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
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
Medical Device Regulations & Registration in Vietnam
If you plan to sell medical devices in Vietnam, there’s a process you can’t skip. The government checks every product
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
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,
Responsibilities of Indian Authorized Agent for Medical Devices Import
An Indian Authorized Agent is an intermediate between the foreign manufacturer and the regulatory authority. Any foreign manufacturer who intends
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
ANMAT Medical Device Regulations and Registration In Argentina
ANMAT is the regulatory authority that regulates the medical device market in Argentina. ANMAT is the Administración Nacional de Medicamentos,