Europe
MHRA Guidance on Medicines and Medical Devices The Medicines and Healthcare products Regulatory Agency (MHRA), the UK authority responsible for medical devices regulation, published updated guidance on distinguishing medicines and medical devices in controversial...
RegDesk News/Info
Changes to Class I Medical Device Requirements in Brazil Agência Nacional de Vigilância Sanitária (ANVISA) is the regulatory body responsible for the regulation and approval of pharmaceuticals and medical devices in Brazil. On March 3, 2019, ANVISA published a...
RegDesk News/Info
Manufacturers and distributors are two separate entities with the same goal in mind– they both want to sell medical devices. Manufacturers want to sell the products that they produce, but because they often have no reach, no network, or not enough resources to carry...
RegDesk News/Info
Oftentimes, medical device manufacturers spend so much time attempting to comply with the complex regulations of their target markets that they fail to direct enough attention toward picking the right distributor for their product. Once a distributor is chosen,...
Asia
#WebinarWednesday is back! Join us on January 23rd at 11am EST to discuss South Korea’s medical device regulations and registration processes with our guest speaker Yoojin Ahn, a leading regulatory affairs and quality assurance expert based in Anyang-si, South Korea....
RegDesk News/Info
“So is RegDesk essentially a regulatory consulting firm?” Questions like these haunt everyone on the ours team. More often than not, inquisitors are quick to slap the “consulting firm” label onto the RegDesk name when attempting to categorize the company. But the...
