Asia
The Government of Vietnam, at the proposal of the Minister of Healthcare, has published a decree amending and supplementing national medical device regulations. The proposed amendments aim to modify a wide scope of provisions and cover numerous aspects related to the...
Indonesia
The MoH in Indonesia has released SIKLARA- a medical device risk classification system that lines up with AMDD. This system aims to be more user friendly, as well as support registrants in determining medical device risk classes. Indonesia’s Device Risk Classification...
Asia
In February, India’s Ministry of Health and Family Welfare released its Medical Device Rules, 2017, a 142-page document that lays out all of the details of the regulations that are now being placed on medical devices that will be sold in the country. Until now,...
