How To Import A “Low Risk” Class Medical Device To Singapore
We often receive requests for registering a low-risk medical device in Singapore.
Here is in a Nutshell what You Need to know
Singapore has four (4) different risk classes for medical devices:
- Class A (low risk);
- Class B (moderately low risk);
- Class C (moderately high risk); and
- Class D (high risk).
A Class A registration is relatively easy, while Classes B, C, and D require a more thorough registration process with HSA, which is the local government agency that is in charge of protecting and advancing national health and safety.
For low-risk medical devices that fall into class A, there is a simplified process that requires a local company in Singapore that is responsible for placing that medical device in the local market. This company has to initiate parallel product registration and dealer license application steps for that specific medical product.
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