As a medical device manufacturer, you are required to submit product data to the GUDID in order meet UDI compliance requirements. If your company markets relatively few products in America, you may simply choose to do so by uploading spreadsheets directly to the...
Global Ophthalmic Medical Devices – Meeting Market Demands According to the Vision Council of America, approximately 75% of adults use some sort of vision correction. And with the rising number of retail chain stores, optometrists and opticians, the global vision...
Despite frequent and rapid changes in the regulation process, companies cannot ignore the value of bringing medical devices to the Chinese market. It is a potential high-growth area for many global medical device manufacturers. So, if you’re a medical device...
The European Database for Medical Devices (EUDAMED) EU MDR, the European Union’s Medical Device Regulation is intended to support both pre-market product registration processes and post-market surveillance & vigilance activities by national regulators across the...
Mistake by Florida on child COVID-19 rate raises the question: Can Florida’s numbers be trusted? “It’s unacceptable to publish information that changes so dramatically that it warrants explanation, and then to not provide any explanation,” said Jason Salemi,...
The US Food and Drug Administration (FDA) has released new guidance regarding Unique Device Identification (UDI) compliance dates for Class I and unclassified medical devices. Effective immediately, the FDA has postponed GUDID (Global UDI Database) compliance for...
