Nov 27 - 4:35
The Ministry of Food and Drug Safety (MFDS), Korea’s national authority responsible for medical device regulation (previously known as Korea Food and Drug Administration or KFDA) issued an update to the requirements...
Nov 26 - 2:29
The Medical Device Authority (MDA), Malaysia’s agency for regulating medical device manufacturing, importation, and distribution, issued guidelines for the registration of drug-device and device-drug combination...
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...
