Classification is the first step in the process. Ensure that your medical device is correctly classified under Class B according to HSA's guidelines. Class B devices are typically low to moderate risk devices.

In Singapore, medical devices are classified based on their risk level, which is determined by the Health Sciences Authority (HSA). The classification system is aligned with international guidelines such as the Global Harmonization Task Force (GHTF) and the ASEAN Medical Device Directive (AMDD).

Ensure that your device is classified as Class B based on its intended use and risk profile according to the HSA classification rules.

The time it takes to obtain A-class medical device registration with the Health Sciences Authority (HSA) in Singapore typically ranges from 4 to 8 weeks. This time frame can vary depending on several factors, including the completeness of your application, HSA's workload, and the nature of the device.

No, A-class medical device registration with the Health Sciences Authority (HSA) in Singapore does not require annual review. However, the registration does have a validity period, and certain obligations remain throughout the life cycle of the device.

Handling A-class medical device registration with the Health Sciences Authority (HSA) in Singapore offers several key benefits, particularly for low-risk medical devices. These benefits include access to a regulated market, streamlined approval processes, enhanced product credibility, and a foundation for expanding into other markets.

Handling A-class medical device registration with the Health Sciences Authority (HSA) in Singapore offers several key benefits, especially for low-risk medical devices. These benefits include access to a regulated market, streamlined approval processes, enhanced product credibility, and a foundation for expanding into other markets.

The time cycle for registering an A-class medical device with the Health Sciences Authority (HSA) in Singapore is generally relatively short due to the low-risk nature of these devices. However, the exact duration can depend on several factors, such as the completeness of your application, HSA's current workload, and the accuracy of the information provided.