i have a company in the US and i want to purchase sterelizers from China for the dental industry and sell them in the states.my question is does the product and the facility where manufactured have to be asme certified in China or can you asme certify the sterelizers in the US and does the facility that manufactures them have to be certified
Hello and welcome to the cove
Those sterilizers may be regulated by FDA as medical devices, and as such may be subject to various controls and requirements, depending on their classification. Among these requirements, a premarket notification ("
510k") submission may be required. If that is the case, both the product and the manufacturing facility will be required to meet prescribed requirements, and certain certifications may be required. However, I'm not currently aware of a specific requirement to provide ASME certificates. Once the relevant classification and product code are verified, the specific requirements (including any certifications) are available online at the FDA's website.
If you provide more specific details regarding the type of sterilizer(s) and intended use, some relevant product codes may be suggested.
Cheers,
Ronen.
Edit: if you're interested in importing dental sterilizers from China in general (not a specific brand), maybe try to look for models that are already 510(k) cleared by / on behalf of the manufacturer.