Jan 21, 2021 | e-Labeling, EMA, Health, Language Service Provider, Medical Translation, Regulatory
On May 26th 2021, the European Union’s Medical Device Directive (MDD) (93/42/EEC) and Directive on Active Implantable Medical Devices (90/385/EEC) will be replaced and fully covered by the Medical Device Regulation (MDR). Since the original medical device directive’s... 
May 4, 2020 | News, Regulatory
The FDA announced that it would strengthen its oversight for companies marketing the COVID-19 serology tests. After questions came to light in regards to the accuracy of some of the testing kits, the FDA is now requiring commercial manufacturers to submit an emergency... 
Jan 21, 2020 | News, Regulatory
Beginning of Changes China released the second draft of the Drug Administration Law of the People’s Republic of China (DAL) to the Committee of the National People’s Congress of China (NPC) for discussion. The first draft adjusted the individual...
