Asia Regulatory Information
Information on Asian regulations and market access for medical devices
Asia Regulatory Information
INDONESIA
Companies wishing to enter the medical device market in Indonesia must follow the regulations set by the Ministry of Health (KEMENKES).
MALAYSIA
The Medical Device Authority (MDA) is a statutory body that regulates the registration of medical devices in Malaysia under the leadership of the Ministry of Health (MOH).
PHILIPPINES
Companies that want to market or sell medical devices or IVD medical devices require a License to Operate (LTO).
SINGAPORE
To register a medical device in Singapore, you must first be registered locally in Singapore with the Accounting and Corporate Regulatory Authority (ACRA).
THAILAND
Before marketing a medical device in Thailand, it must first be registered online through the Pre-submission and E-submission system at the Thai Food and Drug Administration (FDA).
VIETNAM
The Department of Medical Equipment and Construction (DMEC) is the legal entity that regulates the registration of medical devices in Vietnam, under the leadership of the Ministry of Health before medical devices are marketed, imported, exported, or manufactured.
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