Malaysia
- Regulatory Authority:
Medical Device Authority, Ministry of Health Malaysia
- Legislations:
Medical Device Regulations 2012
Medical Device Act 737 2012
Medical Device Authority Act 738 2012
- Registration period:
from 2 to 6 months
(depends on risk class)
- Language:
English
- Certificate validity period:
5 years
- Authorized Representative:
country resident
- Notes:
local tests not required