L
Hello,
I am attempting to import suction cupping sets for use in massage and alternative therapy treatments. From my understanding, this is a Class I medical device. I searched the FDA database and other companies have similar things listed under regulation 890.5765 "Pressure-applying device".
I buy a Chinese brand from a distributor in California, but would like to buy from the manufacturer. The manufacturer says they do not have FDA registration and had no problems selling to US customers.
I'm not sure about this and want to import it correctly without any problems. The California supplier is listed under the FDA as a specification developer for this regulation number.
Whats the best way about importing this item if the manufacturer won't register and list their products? As a initial importer, I think I have to import from registered manufacturers. If I became a specification developer, could I import from non registered manufacturers? I rather not have to pay the FDA fee if at all possible.
Thanks in advance.
I am attempting to import suction cupping sets for use in massage and alternative therapy treatments. From my understanding, this is a Class I medical device. I searched the FDA database and other companies have similar things listed under regulation 890.5765 "Pressure-applying device".
I buy a Chinese brand from a distributor in California, but would like to buy from the manufacturer. The manufacturer says they do not have FDA registration and had no problems selling to US customers.
I'm not sure about this and want to import it correctly without any problems. The California supplier is listed under the FDA as a specification developer for this regulation number.
Whats the best way about importing this item if the manufacturer won't register and list their products? As a initial importer, I think I have to import from registered manufacturers. If I became a specification developer, could I import from non registered manufacturers? I rather not have to pay the FDA fee if at all possible.
Thanks in advance.