Jan 17 - 2:38
In Brazil, the institution that oversees medical device regulations is the Brazilian National Health Surveillance Agency (ANVISA). The beginning of the medical device registration process requires the classification of...
Jan 9 - 1:24
Medical device regulations tend to vary substantially from region to region as virtually every country has its own set of rules that manufacturers must comply with in order to bring a device to market. These...
Nov 8 - 8:07
Although medical device companies are not required to comply with ISO 13485:2016 until March of next year, the International Organization for Standardization (ISO) Technical Management Board is contemplating rewriting...
Oct 29 - 3:31
The International Coalition of Medicines Regulatory Authorities (ICRMA) announced on Friday that they are seeking industry experts for a one year project to ensure proper awareness of track and trace systems for...
Oct 8 - 4:33
ANVISA, Brazil’s drug regulatory body, announced Wednesday at the RAPS’ Regulatory Convergence that more than 800 new and generic drug application backlogs would be eliminated by January 2019. This elimination would...
Apr 10 - 9:17
The National Health Regulatory Agency (NHRA) in Bahrain, has released a circular regarding the importation of medical devices to the country. Medical device shipments must now be pre-approved by the NHRA before...
