Regulatory requirements for export of Medical Devices to Thailand, Australia and US

Hi,

Pl help - we need to export our medical devices subassemblies to customer in Thailand, Australia and US.

Can anyone tell about the regulatory procedures for export of devices from China to Thailand, Australia and US ?

Thanks,

Re: Medical Devices for Thailand, Aust and US

Any answers ?

Re: Medical Devices for Thailand, Aust and US

I'm sorry, but I truely don't know anything about the requirements for export from China. I do hope that there will be someone here who are able to provide some input on this one

Re: Medical Devices for Thailand, Aust and US

For the US you will need a US based agent and will need to meet all US regulations regardless if you have approvals elsewhere. Start by looking at Importing into the U.S. continue from that site. For Australia you will also need a representative in Australia that will hold the license. That is your first step. Your representative in Australia will be familiar with the regulatory requirements. I'm not familiar with the requirements for Thailand, but you might find some information at [FONT=Arial, Helvetica, sans-serif]Medical Device Foreign Regulations.[/FONT]

Thailand FDA should be a good place to start. Also, GOOGLE is your friend.

Re: Medical Devices for Thailand, Aust and US

Al Rosen said:

For the US you will need a US based agent and will need to meet all US regulations regardless if you have approvals elsewhere. Start by looking at Importing into the U.S. continue from that site. For Australia you will also need a representative in Australia that will hold the license. That is your first step.

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Thanks Al. Can you pl let me know for export to EU also ? Do all medical devices require CE marking ?

Re: Medical Devices for Thailand, Aust and US

Qualityalways said:

Thanks Al. Can you pl let me know for export to EU also ? Do all medical devices require CE marking ?

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CE marking is a minimum for the EU. Registration is required for the individual countries. Again, an "Authorized Representative" is required and can help. Please look through the various threads about this subject in the cove. The MDD is posted as well as many other useful documents and links.