Aug 22 - 4:39
Designation According to the notice published by the Medical Devices Division of CDSCO, the regulating authority registered six notified bodies, authorizing them to perform medical device manufacturing site audits, the...
May 22 - 5:49
The Saudi medical regulating authority announced upcoming changes in their medical device regulations. These changes are occurring with the goal to harmonize regulatory requirements with those of the European Union,...
Feb 9 - 1:02
The Turkish Ministry of Health (TMH) recently published a draft regulation to update its current, European Union-aligned Medical Device Regulation. While most of the requirements proposed in the draft regulation are...
Jan 23 - 8:42
The majority of medical devices sold in Japan are paid for by the Japanese National Health Insurance (NHI) system via reimbursement, which is oftentimes an even more critical matter than regulatory compliance. In order...
Jan 20 - 12:17
In Japan, pharmaceuticals and medical devices are regulated by the Pharmaceutical and Medical Device Agency (PMDA) and the Ministry of Health, Labour and Welfare (MHLW). The PMDA is an independent agency that works...
Jan 17 - 9:24
#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...
