EU MDR/IVDR Post-Market Surveillance (PMS)
Manufacturers are expected to have post-market surveillance as a component of their total quality management system. Post-market surveillance ensures the […]
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.
CDSCO Medical Device Regulations & Registration Process In India
India’s medical device market is growing quickly and is now the fourth largest in Asia. The country is pushing to
Global Software as a Medical Device (SaMD) Regulations Guide
Software as a Medical Device (SaMD) is already part of many healthcare systems — from diagnostic tools to monitoring apps
Why Medical Device Submissions Get Rejected (Expert Guide)
Introducing a new medical device to the international market requires that you not only develop a new product, but manufacturers
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
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