Singapore (Health Sciences Authority)
Looking to register and distribute your medical devices here in Singapore? Stendard is the right partner for you. We will help you to strategise, classify and group your products accordingly, which will help you to save up significantly on the cost and time to register your medical device. At the same time, we can also help review your current documentation and re-package them into the ASEAN CSDT format required by the Health Sciences Authority (HSA) of Singapore.
US, Europe, China, ASEAN and rest of the world
If you are deciding to market your medical devices into the global markets, our QMS preparation (ISO 13485 and US FDA 21 CFR) has already gotten you prepared for the global market. In addition, we work closely with our affiliated partners based in the US, Europe, China, ASEAN countries and other parts of the world to help you overcome the local registration requirements, while we remain as the main point of contact for you.
Local License Holder / Representative
As a local in-country licence holder representing your organisation, we remain impartial and allow you to swiftly register your products with the local regulatory authorities. You may also switch distributors at any time, without any fears of confidentiality concerns, as well as incurring further costs and delays with local business activities.