Completeness of the Application: If all required documents are submitted correctly and completely, the process will generally be quicker. Incomplete or incorrect applications may require additional time to address the issues.

Validity Period: The registration of a D-class medical device is valid for 5 years from the date of approval.

Market Authorization: Once registered, the device is legally authorized to be sold and marketed in Singapore, which opens up business opportunities within the country.

Completeness of the application: If the required documents are complete and correctly submitted, the process will be faster. Incomplete or incorrect submissions may cause delays as HSA may request additional information.

D-class medical device registration with the Health Sciences Authority (HSA) in Singapore refers to the regulatory process for registering low-risk medical devices that are intended for use in healthcare settings.

To apply for D-class medical device registration with the Health Sciences Authority (HSA) in Singapore, you will need to follow a structured process to ensure compliance with the country’s regulatory requirements for medical devices. Below is a detailed guide on how to register and apply for D-class medical device registration in Singapore.

To apply for D-class medical device registration in Singapore with the Health Sciences Authority (HSA), you must follow a clear process to ensure that your device meets regulatory requirements. The process involves several steps, including preparing necessary documents, submitting the application, and waiting for approval.

Class D medical devices are considered low-risk devices and typically do not require extensive clinical data or a detailed regulatory pathway.