Mexico COFEPRIS Announces Revised Draft Labeling Standard
The medical device regulator in Mexico, COFEPRIS, recently released a new project for the NOM for Medical Device labeling, NOM-137-SSA1-2024 that is open for industry comment.
A Busy Few Months for Brazil ANVISA
This update summarizes Brazil's medical device regulatory activity for the first months of 2024.
Hong Kong Regulatory Updates: Additional Leveraged Country Authorizations and a Digital Platform
Medical device makers who want to access the Hong Kong market must comply with the latest regulatory requirements in this special administrative region of China.
Singapore HSA-Thai FDA Reliance Program for Medical Devices
In this on-demand webinar, our Emergo by UL’s expert shares insights on how to navigate the Singapore HSA-Thai FDA Reliance Program for Medical Devices.
Mexico COFEPRIS Announces Revised Labeling Standard
This is the first in a series of regulatory updates on the labeling standard for medical devices, IVDs and pharmaceuticals in Mexico.
Software Development Lifecycle Regulatory Compliance for Medical Devices
Learn more about the software development lifecycle to increase software safety reliability and compliance with international standards.
Software Development Lifecycle Training
Our software development lifecycle (SDLC) training supports conformity to IEC 62304 and IEC 82304 standards.
EU Update: New Guidance on Clinical Investigation Investigator's Brochures
Medical device makers doing business in the EU should become familiar with the regulatory requirement of providing an investigator’s brochure (IB).
Second Report on the European Clinical Evaluation Consultation Procedure (CECP)
The EC published its second overview of the Clinical Evaluation Consultation Procedure (CECP) (Article 54) of the Medical Devices Regulation (MDR) 2017/745.
Update for EU Amending Regulation and Regulators Who Leverage CE Marking Certificates
Regulators are scrambling to confirm that their provisions regarding leveraging CE Marking Certificates are sufficiently aligned to Regulation 2023/607 by the May 26, 2024 deadline.