1.
Chinese Journal of Medical Instrumentation
;
(6): 61-63, 2016.
Artigo
em Chinês
| WPRIM
| ID: wpr-265571
RESUMO
This paper introduces the premarket registration procedures and the post market regulatory requirements in India. According to Indian medical device act and related medical regulations on medical device, this is a preliminary discussion on the registration management system to provide referance for foreign medical device to enter India market.
Assuntos
Equipamentos e Provisões , Economia , Padrões de Referência , Índia
2.
Chinese Medical Equipment Journal
;
(6): 124-126,131, 2015.
Artigo
em Chinês
| WPRIM
| ID: wpr-600537
RESUMO
The concept and classification of Korean medical device were introduced. The phases for Korea to import medical device include selecting Korean certification holder, hospital admittance, device marketing and supervision after marketing. China and other countries can find references to export medical devices into Korea.