NMPA releases a final guidance on Device Master File (DMF) submissions
As per the Announcement no. 36 of 2021, lists requirements for voluntary submission of domestic Class III and imported Class II and III medical devices and IVDs.
New Rules for Cosmetics Registration in China starting May 2021
The new regulations on cosmetics in china are coming into effect on May 1st, 2021. They include new classification of cosmetic product, new requirements for the ingredients, labeling, safety assessment and animal testing.
Anvisa approves the emergency use of antibodies for Covid-19 treatment
The indication for use is for mild and moderate Covid-19 cases in adults and pediatric patients (12 years and older) with laboratory-confirmed infection.
EU Medical Device Regulation Technical Documentation Structure and Requirements
The main purpose of technical documentation in the EU Medical Device Regulation (MDR) is to prove that a medical device meets the general safety and performance requirements.
Mexico’s Cofepris Submits preliminary draft amendment of the Health Products Regulation
On April 7th, Cofepris submitted a preliminary draft amendment on Heath products regulation with the goal to optimize current practices based on best practices of international regulatory agencies.
FioCruz reinforces the position adopted by Anvisa, EMA and WHO on vaccine safety
Confidentiality agreement between the two regulatory authorities confirms Anvisa’s recognition on the international scene.