Which Products Are Subject to the EU Data Act?
Recently, more and more companies exporting to the EU have encountered a new issue: European buyers require products to comply
Regulatory News
Global medical device regulatory updates and registration guides
2026 Guide to Saudi SFDA Medical Device Registration and Doing Business: New Regulations and Market Access Explained
As Saudi Arabia’s Vision 2030 strategy advances, the largest medical device market in the Middle East is undergoing a deep
An Underestimated Market Opportunity: The Industry Being “Medicalized” Behind the Shanghai Adult Expo
The 2026 Shanghai Adult Expo was busier than ever. But what really deserves attention is not just its size, but
FDA: The Complete Compliance Path for Medical Device Biocompatibility Submissions
In FDA submissions for medical devices, biocompatibility assessment is an unavoidable core element. The FDA guidance Use of International Standard
FDA ASCA Program: What Manufacturers Need to Know About Accredited Testing Laboratories
How the FDA ASCA program works, why the accreditation body matters, and what to check before relying on an ASCA test report.
US FDA De Novo (New Classification) Requests for Medical Devices
This article focuses on De Novo classification requests to the US FDA. The five most common FDA submission types are:
US FDA Medical Device 510(k) Submissions
This article focuses on 510(k) submissions to the US FDA. A 510(k) is a premarket submission made to the FDA
Vietnam IMDA Medical Device Registration
This article focuses on Vietnam’s IMDA medical device registration rules and introduces the requirements for registering medical devices in Vietnam.
Singapore HSA Medical Device Registration
In Singapore, medical devices are regulated by the Health Sciences Authority (HSA). Established in April 2001 under the Ministry of
Overview of FDA Medical Device Regulation
In the US, medical devices are regulated by the FDA’s Center for Devices and Radiological Health (CDRH), which is highly