Registration in Singapore
Access to the Singaporean market
The main regulatory authority in Singapore is the Health Sciences Authority (HSA). Since 2007, HSA requires medical device registration, regulating supply, distribution, manufacturing, import, and marketing of all health products.
Registered devices are listed on the Singapore Medical Device Register (SMDR). Devices are classified into four classes (A, B, C, D), with Class A representing the lowest risk and Class D the highest.
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