China
- Regulatory Authority:
National Medical Products Administration (NMPA)
- Legislations:
Order No.650 of the State Council of the People’s Republic of China, 2014
- Registration period:
5 to 6 months
Class I devices (by notification):
15 to 32 months
Class II and III devices (registration):
- Language of labeling and documentation:
Chinese, English
- Certificate validity period:
5 years
- Authorized Representative:
country resident