Changes to Good Manufacturing Practice Regulations in Mexico: SaMD, UDI and More
In this second update, we discuss the change in the organization of PROY-NOM-241-SSA1-2024 on Good Manufacturing Practices.
US FDA Reorganizes Medical Device Guidance Databases
This regulatory update discusses how the U.S. Food and Drug Administration (FDA) recently adapted certain searches and information to highlight regulatory guidance for specific medical device types.
Japan Regulatory Requirements – Medical Device Software
In this on-demand webinar, our Emergo by UL subject matter expert shares insights on Japanese regulatory requirements for medical device software.
Mexico COFEPRIS Revises Draft of GMP Standard
Mexican market regulator COFEPRIS released a new draft of the NOM for Medical Device Good Manufacturing Practices, PROY-NOM-241-SSA1-2024, on July 26, 2024.
The Benefits of Developing Design Systems for Medical Products
Emergo by UL human factors specialists share considerations when developing medical products and outline benefits for establishing design systems.
Mexico COFEPRIS Revises Draft of Technovigilance Standard
The regulator in Mexico, COFEPRIS, released a new draft on July 24, 2024, for the NOM for Medical Device Technovigilance, PROY-NOM-240-SSA1-2024. This draft will be open for input and comments until Sept. 29, 2024.
Israel Registration Update: Modifications and Renewals
As reported by Emergo by UL, the Ministry of Health of Israel is implementing reforms to the registration process for medical devices and IVDs. Our first regulatory update described the three registration routes in Israel: Declaration Route, Fast-Track Route, and Normal Route. The second in the series presents details about the changes to modifications and renewals under this regulatory reform.
Optimizing a QMS for Medical Device Companies
In this on-demand webinar, our Emergo by UL subject matter expert shares insights on how to optimize a QMS for global medical device companies.
Due Diligence Services for Mergers and Acquisitions
Our due diligence services help medical device companies navigate complex regulatory requirements to avoid post-transaction complications.
Regulatory Analysis for Medical Device Mergers and Acquisitions
We will analyze the regulatory impact of the envisioned merger or acquisition and outline a regulatory roadmap by country for prioritization.