Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros. These updates are presented by China Med Device,...

Covidien issued voluntary recall notice for Coated Braided Nylon Nonabsorbable Suture on January 4, 2024. It is a Class I recall, which indicates the...

NMPA published the four IVD-related guidelines on January 18, 2024. They are aimed to facilitate manufacturers with more product-specific guidance and clarity in registration...

NMPA published the twelve guidelines for in vitro diagnostic reagents related products on January 3, 2024. It comes as the File No.1 released by...

NMPA published the “Guideline on Core Raw Materials of In Vitro Diagnostic Reagents” on January 3, 2024, along with eleven IVD related guidance. It...

The article highlights the key points associated with the regulatory framework for specific categories of medicinal products. Table of content ...

NMPA conducted on-site quality inspection on eleven types of medical devices and released the result on December 18, 2023. Eighteen manufacturers are found incompliance,...

This blog provides a deep dive into the newest version of the FDA eSTAR, version 5.0, released on December 6, 2023. Why did the FDA...

The new article highlights the aspects related to the inclusion of new products in the Australian Register of Therapeutic Goods (ARTG), a country’s register...

As we eagerly anticipate the 14th China International Medical Device Regulatory Forum (CIMDR) from March 30 to April 4, 2024, we find ourselves reflecting...

WASHINGTON, Dec. 13, 2023 /PRNewswire/ -- MCRA, the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm...