Getting Started with Japan PSE Certification | History and Product Categories Explained
Introduction: Want your products to enter the Japanese market smoothly? Then you need to know one key term – PSE
Regulatory News
Global medical device regulatory updates and registration guides
Exporting Veterinary Medical Equipment to the US: Compliance Requirements Explained!
In recent years, with the rapid growth of the pet health industry, “veterinary medical devices” such as pet therapy devices,
The EU AI Act and Its Application Under the MDR
At EU level, medical devices (including AI medical devices) are mainly regulated by the MDR. The MDR aims to ensure
Key Compliance Points for Biosafety Cabinets Under GB 41918-2022
The new national standard GB 41918-2022 “Biosafety Cabinets” replaces YY 0569-2011 “Class II Biosafety Cabinets” and regulates biosafety cabinets as
NMPA Registration: Sample Third-Party Warehousing and Transport Documents for Medical Device Distributors
When third-party warehousing and transport companies apply for the first time, they often face the dilemma of having no real
The Core of CE Certification: Conformity Assessment Modules Explained
CE conformity assessment modules are the core operational framework of the CE marking system. Their key role is to define
EU Safety Requirements for General Consumer Products
Regulation (EU) 2023/988 on general product safety (GPSR) was adopted on 10 May 2023, entered into force on 30 May
Core Parts of 21 CFR Relevant to the FDA
The FDA (US Food and Drug Administration) regulatory framework for medical devices consists of multiple parts of 21 CFR (Code
FDA Medical Device Recalls Explained
A recall is a method of removing or correcting products that violate laws administered by the US Food and Drug
FDA Warning Letters to Medical Device Companies Explained
The core value of FDA warning letters is that they clearly show “which practices do not comply with regulations”. The