Overview of Medical Device Anvisa Regulations in Brazil

Overview of Medical Device Anvisa Regulations in Brazil

The most important regulation for Medical Devices in Brazil is RDC 751/2022, which provides for the risk classification, notification and registration regimes, labeling requirements, and instructions for use of medical devices.

US FDA Releases Food Allergen Labeling

US FDA Releases Food Allergen Labeling

In May 2023, the U.S. Food and Drug Administration issued five more final orders completing the process of publishing different monographs as part of the over the counter (OTC) monograph reform under the Act CARES.

REGISTRATION OF DRUG MASTER FILE (DMF) IN JAPAN

In Japan, the Drug Master File (DMF) is called “Master File” or “MF”. The Purpose of DMF is to protect the “know-how” of API manufacturing methods against the marketing authorization applicant (MAA) / holder (MAH) of pharmaceutical products.  The foreign manufacturers of APIs can apply for DMF registration.

US-FDA Formal Meetings with OTC Sponsors

Overview: On February 1st, 2022, the US Food and Drug Administration (FDA) issued a draft of guidance on formal meetings between sponsors of over-the counter (OTC) monograph drugs and the agency.The guidance clarifies how sponsors can obtain advice on studies to support their submissions. It also addresses meeting types, meeting formats, content of meeting requests […]

US-FDA TRANSITION PLAN FOR MEDICAL DEVICE UNDER EUA IN USA

On December 31st, 2021, the US Food and Drug Administration (FDA) published the draft of new guidance that outlines the transition plan for devices granted and marketed in USA under EUA designation during the coronavirus pandemic.