Importing exempt Class I device from non-registered manufacturer

L

LloydC

#1
#1
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.
 
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MIREGMGR

#2
#2
LloydC said:
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.
Click to expand...
Every medical device marketed in the US must be the legal responsibility of a particular company, as indicated by that company having registered with the FDA and listed that device at the FDA DRLM site. Since the product is made by a non-registered company, it is not a medical device when they sell it. Thus if you bring it into the US, it must be on the basis that you are importing a non-medical-device object and making it into a medical device. You can do this as a Specification Developer or a Manufacturer...there is no practical difference in this context, as you have 100% responsibility for the device in any case. You will be responsible for the maker's quality control, biocompatibility, etc., in regard to the units they sell you.

There is no legal way to do what you seek to do without registering and listing with the FDA.

Aside from the ethical and legal constraints, the California supplier would have both motivation and knowledge to observe your actions in the marketplace and "drop a dime on you" with FDA if you were marketing a product as a device without registering and listing.
 
bio_subbu

bio_subbu

Super Moderator
#3
#3
To import a medical device both the U.S. initial distributor/importer and the foreign manufacturer have to register with the FDA. An initial distributor/importer is only required to register with the FDA. A foreign manufacturer must register their establishment with the FDA, list their devices, and pay the establishment registration fee. If you were to become a specification developer, you would have to register, list, and pay the fee. If you use a foreign contract manufacturer, the foreign contract manufacturer is also required to register, list and pay the fee.

Please refer below link on “Who Must Register, List and Pay the Fee”

http://www.fda.gov/MedicalDevices/D...urDevice/RegistrationandListing/ucm053165.htm

As regards to registration instructions refer below FDA links

http://www.fda.gov/MedicalDevices/D...urDevice/RegistrationandListing/ucm053185.htm.

http://www.fda.gov/MedicalDevices/D...YourDevice/RegistrationandListing/default.htm

Hope you will find useful and relevant.

Regards
S. Subramaniam
 
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