Health Products Act (HPA) and the Health Products (MD) Regulations 2010
HSA Medical Device Regulations in Singapore
In Singapore, the Health Sciences Authority (HSA) is responsible for medical device safety, quality control, and vigilance. The HSA regulates medical devices and in-vitro diagnostic devices under the Health Products Act (HPA) and the Health Products (Medical Devices) Regulations 2010. Qserve supports medical device and IVD manufacturers with the HSA Medical Device Regulations in Singapore.
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Medical Device Classification in Singapore
HSA Medical Device Regulations in Singapore
Manufacturers must register all medical devices in Singapore’s Medical Device Information Communication System (MEDICS) and be approved by HSA before manufacturers can supply them in Singapore, except for some low-risk Class A devices. They are exempted from product registration. The registration and documentation requirements depend on the device’s risk classification and the type of evaluation route.
Singapore has recognized certain overseas regulatory approvals from countries such as Australia, Canada, Japan, the US, and the EU. These are known as Overseas Reference Regulatory Agencies. Singapore closely follows the countries that participate in the MDSAP. This shows that it is useful to consider Singapore as part of your market access strategy in determining your MDSAP approach.
Depending on your overseas approval and available data and evidence, you can select the most suitable approach for your device to meet the HSA Medical Device Regulations in Singapore.
Registration routes in Singapore
Submission pathways
There are four types of evaluation routes:
- Full Route (with or without priority)
This route applies to devices that are not approved in one of the overseas reference regulatory agencies.
- Abridged Route
The abridged route is used when your device is at least approved by one of the overseas reference regulatory agencies, irrespective of the risk class.
- Expedited Route
This is a fast-track approach. However, it is not only dependent on overseas approval. This approach is also depending on the risk class of the device.
- Immediate Route
This route can be in specific cases depending on the risk class and number of years the device has been marketed without any safety issues.
Find comprehensive details about the evaluation routes in the blog Things You Need To Know about Medical Device Registration in Singapore.