Looking to distribute your medical devices here in Singapore? We are the right partner for you. We can help you to classify and group your products as well as advising on the timeline, cost and effort required for product registration. At the same time, we can also help review your current documentation and re-package them into the CSDT format required by the Health Science Authority (HSA) of Singapore.
US, Europe, china and rest of world
For companies deciding to market your medical devices into the global markets, our QMS (ISO 13485 and US FDA QSR) and regulatory consultancy efforts ensure that your medical devices are ready for registration in the target markets. We have our affiliated partners in US, Europe, China and other parts of the world to assist in the registration strategy and process. As such, we have the registration risk mitigated to as low as possible.