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Recap 2023 : Key Medical Device Regulatory highlights in Asia and ROW

Medical Device

ASIA CHINA Notice from the Device Review Center of the State Food and Drug Administration on the release of key points for the functional review of artificial intelligence software for magnetic...

Healthcare Compliance, Medical Devices, Regulatory Updates

Cosmetic Labeling Requirements & Guidelines

Cosmetics

To ensure consumer safety, it is crucial for cosmetic manufacturers to be meticulous in labeling their pTo protect consumer safety, cosmetic manufacturers must ensure accurate, complete, and transparent...

Pharma/Biotech – Asia, ROW Regulatory News, Nov. 2023 Vol. 2

Biopharma

ASIA MALAYSIA Revised Guideline for Facilitated Registration Pathway (FRP) Malaysia’s NPRA has updated its Facilitated Registration Pathway (FRP) guideline. The revised framework now includes...

Asia Regulatory News, BioTech, Conditional Approval, Facilitated Registration Pathway, Pharma, Regulatory Updates, ROW Regulatory News, Therapeutic Goods

Medical Devices-Asia and ROW Regulatory News-Nov. 2023

Medical Device

ASIA CHINA NMPA released Guidance Draft for comments on 54 guiding principles for registration review of Class II medical devices including the “Guiding Principles for Registration Review of...

Asia Regulatory News, Clinical Evaluation, Medical Devices, Regulatory News, ROW Regulatory News

Challenges, Benefits, and Future Trends in Compliance Intelligence

Medical Device

Regulatory compliance—often referred to as business compliance—covers an organization’s responsibility to follow all applicable laws, regulations, and governing standards. Compliance Intelligence tools...

Compliance Intelligence, Medical Device Industry. Compliance Intelligence, Regulatory Compliance

Modifications to Medical Device Registration in Mexico

Medical Device

In August 2023, the COFEPRIS, the Mexican Regulatory body in charge of the regulation of Medical Devices, revised the Guidance Document by defining types and impact of product or organizational modifications...

COFEPRIS, Medical Device Regulations, Medical Devices, Mexico, Regulatory Guidelines